For questions about BMS medicines during this time, please call 1-800-721-8909.

What is EMPLICITI® (elotuzumab)?

EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines:

  • REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.
  • POMALYST® (pomalidomide) and dexamethasone in adults who have received at least two prior treatments including REVLIMID and a proteasome inhibitor.

It is not known if EMPLICITI, REVLIMID, or POMALYST is safe and effective in children.

Patients and their loved ones share their
stories about relapsed multiple myeloma

Patients and their loved ones share their
stories about relapsed multiple myeloma

INSPIRING STORIES

Hear from other patients who continued their journeys with EMPLICITI® (elotuzumab).

I had actually gone to my doctor with something that had nothing to do with myeloma or anything that they found. And they ran some blood tests and I got a call from my GP saying that she had found this protein in my blood, which turned out to be multiple myeloma, and that was a cancer. Of course, the idea that I had a cancer in my blood was horrifying. I was in shock for a while—I couldn’t tell people about it.

I had different treatments and then EMPLICITI with POMALYST and dexamethasone. I’m not really sure what’s coming up next. But I see a lot of possibilities. I’m just going to keep on going.

Florence, Dinah's friend

Florence’s story

DINAH’S FRIEND

When the symptoms became obvious, Dinah came to me and she started the question of would I be one of her primary caretakers. It was a Saturday morning, she called me up. She started to speak, I said just cut to the chase, the answer is yes. Why not? I love you dearly, you’re like a sister to me.

Susan, Dinah's sister

Susan’s story

DINAH’S SISTER

Dinah has always been extremely strong. She had the point where she broke down, but then she got back up and said, I’m going to do what it takes. It never really defeated her. She just kept going. I admire her—she’s just amazing.

Read more about Dinah’s story

I had actually gone to my doctor with something that had nothing to do with myeloma or anything that they found. And they ran some blood tests and I got a call from my GP saying that she had found this protein in my blood, which turned out to be multiple myeloma, and that was a cancer. Of course, the idea that I had a cancer in my blood was horrifying. I was in shock for a while—I couldn’t tell people about it.

I had different treatments and then EMPLICITI with POMALYST and dexamethasone. I’m not really sure what’s coming up next. But I see a lot of possibilities. I’m just going to keep on going.

Florence, Dinah's friend

Florence’s story

DINAH’S FRIEND

When the symptoms became obvious, Dinah came to me and she started the question of would I be one of her primary caretakers. It was a Saturday morning, she called me up. She started to speak, I said just cut to the chase, the answer is yes. Why not? I love you dearly, you’re like a sister to me.

Susan, Dinah's sister

Susan’s story

DINAH’S SISTER

Dinah has always been extremely strong. She had the point where she broke down, but then she got back up and said, I’m going to do what it takes. It never really defeated her. She just kept going. I admire her—she’s just amazing.

Dinah talks about her experience with EMPLICITI.

After you watch the video, learn more about how to receive EMPLICITI.

Dinah is a former patient who received EMPLICITI + POMALYST® (pomalidomide)* + dexamethasone

Dinah:

I started doing pottery, it was a hobby. And then it turned into a business for a while... I just, I enjoy it. It’s something that calms me down...it centers me. When you’re centering a piece of clay... I think you center yourself.

I’m Dinah, and I have multiple myeloma. I had actually gone to my doctor with something that had nothing to do with the myeloma or anything that they found. And they ran some blood tests and I got a call from my GP saying that she had found this protein in my blood...and she wanted to explore that further.

Susan:

When Dinah called me after she had gotten her diagnosis, she told me that she had multiple myeloma, and I said, “What?” You know. “What is that and what does that mean?” And she said, “It’s cancer,” and then that’s when she broke apart.

Florence:

When Dinah was initially diagnosed, she was asymptomatic...you know, so the dream, the hope is that she would stay that way...but she didn’t. And within 5 or 6 years...when the symptoms became obvious… she came to me and she started the question of would I be one of her primary caregivers.

Dinah:

You have to have those kind of people in your life that are cheerleaders for you. We started looking at different ways to treat the myeloma. I did drop my numbers some. That kept me going for a number of years. And then the numbers started rising again. That was really hard. It still brings me up a little emotions. I just burst into tears. I went back to my doctor, my specialist…and he said I’ve got this trial…that I want you to go into. He said it involves this drug, EMPLICITI, which is an immunotherapy drug.

Voice Over:

Keep watching to hear more of Dinah’s story

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine, taken along with the medicines POMALYST® (pomalidomide) and dexamethasone used to treat adults with multiple myeloma who have received at least two prior treatments including lenalidomide and a proteasome inhibitor.

It is not known if EMPLICITI or POMALYST are safe and effective in children.

SELECTED IMPORTANT SAFETY INFORMATION ABOUT EMPLICITI

EMPLICITI® in combination with POMALYST® (pomalidomide) and dexamethasone may cause the following serious side effects: infusion reactions, infections, risk of developing new cancers (malignancies), liver problems.

There are also other serious risks (Boxed WARNINGS) associated with POMALYST. POMALYST can cause harm to unborn babies and blood clots. POMALYST is only available through the POMALYST REMS® program. More information on the REMS program is available at www.CelgeneRiskManagement.com or by calling 1-888-423-5436. Please listen to the Important Safety Information at the end of this video including more information about serious side effects. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI with POMALYST and dexamethasone. It is not known if EMPLICITI or POMALYST are safe and effective in children.

DINAH:

It was like a light was turned on, ok here, there are possibilities. This is working really well right now. Everything’s been holding…I’ve got all these projects that I’ve got to do now, and I find that really exciting.

FLORENCE:

I want her to be alive for years and years and years.

SUSAN:

It just never really defeated her. You know, she just kept going.

DINAH:

I like the fact that people don’t look at me and say…“Here’s a person that has cancer.” I’m not really sure what’s coming up next. But I see a lot of possibilities. And I’m just gonna keep on going.

Voice Over:

This is important safety information that you need to know about EMPLICITI and POMALYST. Your healthcare team can work with you to help answer any questions you may have about EMPLICITI and POMALYST.

WARNINGS: Risk to unborn babies, and blood clots.

What is the most important information I should know about POMALYST®?

Before you begin taking POMALYST, you must read and agree to all of the instructions in the POMALYST REMS® program. Before prescribing POMALYST, your healthcare provider (HCP) will explain the POMALYST REMS program to you and have you sign the Patient-Physician Agreement Form.

POMALYST can cause serious side effects, including possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take POMALYST.

POMALYST is similar to the medicine thalidomide (THALOMID®), which is known to cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.

Females must not get pregnant for at least 4 weeks before starting POMALYST, while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for at least 4 weeks after stopping POMALYST.

Females who can become pregnant will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.

Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in treatment, and for at least 4 weeks after stopping POMALYST.

Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after your treatment with POMALYST®. If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and Celgene Corporation at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

POMALYST® can pass into human semen.

Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.

Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.

Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects. Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.

Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.

Before taking POMALYST, tell your healthcare provider if you have had a blood clot in the past. If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia).

About all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST®:

Signs or symptoms of a blood clot in the lung, arm, or leg may include shortness of breath, chest pain, or arm or leg swelling.

Signs or symptoms of a heart attack may include chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.

Signs or symptoms of stroke may include sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance, a red, itchy skin rash, peeling of your skin or blisters, severe itching, fever.

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with POMALYST: swelling of your lips, mouth, tongue, or throat. Trouble breathing or swallowing. Raised red areas on your skin (hives). A very fast heartbeat. You feel dizzy or faint.

Who should not take POMALYST?
Do not take POMALYST if you are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. See “What is the most important information I should know about POMALYST?”

Are allergic to pomalidomide or any of the ingredients in POMALYST.

What should I tell my healthcare provider (HCP) before taking EMPLICITI and POMALYST®?

If you smoke cigarettes (POMALYST may not work as well in people who smoke), have any other medical conditions, or are breastfeeding. Do not breastfeed during treatment with EMPLICITI, POMALYST and dexamethasone—it is not known if EMPLICITI and POMALYST pass into breast milk and can harm the baby.
If you have liver problems.
If you have kidney problems and are receiving hemodialysis treatment.
Have an infection.

Are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, POMALYST may cause birth defects or death to an unborn baby. Have any other medical conditions.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. POMALYST and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines.

How should I take POMALYST?
Take POMALYST exactly as prescribed and follow all the instructions of the POMALYST REMS program.

Swallow POMALYST capsules whole with water 1 time a day. Do not break, chew, or open capsules.

Take POMALYST at the same time each day with or without food.

If you are on hemodialysis, take POMALYST after hemodialysis on hemodialysis days.
Do not open POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.

If you miss a dose of POMALYST and it has been less than 12 hours since your regular time, take POMALYST as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

If you take too much POMALYST, call your healthcare provider (HCP) right away.
Do not share POMALYST with other people. It may cause birth defects and other serious problems.

What are the possible side effects of EMPLICITI and POMALYST®?

See “What is the most important information I should know about POMALYST?”
EMPLICITI and POMALYST can cause serious side effects, including low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked by your healthcare provider (HCP) weekly for the first 8 weeks of treatment and monthly after that.

Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with EMPLICITI and POMALYST. Tell your HCP right away if you develop any of the following symptoms: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; color changes in your stool; pain or swelling on the upper right side of your stomach area (abdomen); confusion; bleeding or bruising more easily than normal, or feeling very tired.

Infusion Reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, chest pain, trouble breathing, dizziness, or light-headedness.

Infections. Those receiving EMPLICITI with POMALYST® and dexamethasone may develop infections; some can be serious. Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash. Severe allergic and severe skin reactions can happen with POMALYST and may cause death.

Dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.

Nerve damage. Stop taking POMALYST and call your HCP if you develop numbness, tingling, pain, or a burning sensation in your hands, legs, or feet.

New cancers (malignancies). New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Those receiving EMPLICITI with POMALYST and dexamethasone have a risk of developing new cancers. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI, POMALYST and dexamethasone. Talk with your HCP about your risk of developing new cancers.

Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS.

The most common side effects of EMPLICITI when used with POMALYST and dexamethasone include constipation and high blood sugar.

The most common side effects of POMALYST include tiredness and weakness, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infection, back pain, and fever.

These are not all the possible side effects of EMPLICITI and POMALYST®. Your HCP may tell you to stop taking POMALYST if you develop certain serious side effects during treatment. Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read EMPLICITI Full Prescribing Information and Patient Information on this website. Please read POMALYST Full Prescribing Information, including Boxed WARNINGS and Medication Guide on this website.

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine, taken along with the medicines POMALYST (pomalidomide) and dexamethasone used to treat adults with multiple myeloma who have received at least two prior treatments including lenalidomide and a proteasome inhibitor.

What is POMALYST® (pomalidomide)?
POMALYST is a prescription medicine, taken along with the medicine dexamethasone, used to treat adults with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment.

It is not known if EMPLICITI or POMALYST is safe and effective in children.

© 2021 Bristol-Myers Squibb Company. All rights reserved.
US-EMP-21-0005 02/21

Watch Video
Fullscreen

View Video Transcript

Dinah:

I started doing pottery, it was a hobby. And then it turned into a business for a while... I just, I enjoy it. It’s something that calms me down...it centers me. When you’re centering a piece of clay... I think you center yourself.

I’m Dinah, and I have multiple myeloma. I had actually gone to my doctor with something that had nothing to do with the myeloma or anything that they found. And they ran some blood tests and I got a call from my GP saying that she had found this protein in my blood...and she wanted to explore that further.

Susan:

When Dinah called me after she had gotten her diagnosis, she told me that she had multiple myeloma, and I said, “What?” You know. “What is that and what does that mean?” And she said, “It’s cancer,” and then that’s when she broke apart.

Florence:

When Dinah was initially diagnosed, she was asymptomatic...you know, so the dream, the hope is that she would stay that way...but she didn’t. And within 5 or 6 years...when the symptoms became obvious… she came to me and she started the question of would I be one of her primary caregivers.

Dinah:

You have to have those kind of people in your life that are cheerleaders for you. We started looking at different ways to treat the myeloma. I did drop my numbers some. That kept me going for a number of years. And then the numbers started rising again. That was really hard. It still brings me up a little emotions. I just burst into tears. I went back to my doctor, my specialist…and he said I’ve got this trial…that I want you to go into. He said it involves this drug, EMPLICITI, which is an immunotherapy drug.

Voice Over:

Keep watching to hear more of Dinah’s story

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine, taken along with the medicines POMALYST® (pomalidomide) and dexamethasone used to treat adults with multiple myeloma who have received at least two prior treatments including lenalidomide and a proteasome inhibitor.

It is not known if EMPLICITI or POMALYST are safe and effective in children.

SELECTED IMPORTANT SAFETY INFORMATION ABOUT EMPLICITI

EMPLICITI® in combination with POMALYST® (pomalidomide) and dexamethasone may cause the following serious side effects: infusion reactions, infections, risk of developing new cancers (malignancies), liver problems.

There are also other serious risks (Boxed WARNINGS) associated with POMALYST. POMALYST can cause harm to unborn babies and blood clots. POMALYST is only available through the POMALYST REMS® program. More information on the REMS program is available at www.CelgeneRiskManagement.com or by calling 1-888-423-5436. Please listen to the Important Safety Information at the end of this video including more information about serious side effects. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI with POMALYST and dexamethasone. It is not known if EMPLICITI or POMALYST are safe and effective in children.

DINAH:

It was like a light was turned on, ok here, there are possibilities. This is working really well right now. Everything’s been holding…I’ve got all these projects that I’ve got to do now, and I find that really exciting.

FLORENCE:

I want her to be alive for years and years and years.

SUSAN:

It just never really defeated her. You know, she just kept going.

DINAH:

I like the fact that people don’t look at me and say…“Here’s a person that has cancer.” I’m not really sure what’s coming up next. But I see a lot of possibilities. And I’m just gonna keep on going.

Voice Over:

This is important safety information that you need to know about EMPLICITI and POMALYST. Your healthcare team can work with you to help answer any questions you may have about EMPLICITI and POMALYST.

WARNINGS: Risk to unborn babies, and blood clots.

What is the most important information I should know about POMALYST®?

Before you begin taking POMALYST, you must read and agree to all of the instructions in the POMALYST REMS® program. Before prescribing POMALYST, your healthcare provider (HCP) will explain the POMALYST REMS program to you and have you sign the Patient-Physician Agreement Form.

POMALYST can cause serious side effects, including possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take POMALYST.

POMALYST is similar to the medicine thalidomide (THALOMID®), which is known to cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.

Females must not get pregnant for at least 4 weeks before starting POMALYST, while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for at least 4 weeks after stopping POMALYST.

Females who can become pregnant will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.

Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in treatment, and for at least 4 weeks after stopping POMALYST.

Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after your treatment with POMALYST®. If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and Celgene Corporation at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

POMALYST® can pass into human semen.

Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.

Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.

Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects. Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.

Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.

Before taking POMALYST, tell your healthcare provider if you have had a blood clot in the past. If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia).

About all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST®:

Signs or symptoms of a blood clot in the lung, arm, or leg may include shortness of breath, chest pain, or arm or leg swelling.

Signs or symptoms of a heart attack may include chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.

Signs or symptoms of stroke may include sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance, a red, itchy skin rash, peeling of your skin or blisters, severe itching, fever.

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with POMALYST: swelling of your lips, mouth, tongue, or throat. Trouble breathing or swallowing. Raised red areas on your skin (hives). A very fast heartbeat. You feel dizzy or faint.

Who should not take POMALYST?
Do not take POMALYST if you are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. See “What is the most important information I should know about POMALYST?”

Are allergic to pomalidomide or any of the ingredients in POMALYST.

What should I tell my healthcare provider (HCP) before taking EMPLICITI and POMALYST®?

If you smoke cigarettes (POMALYST may not work as well in people who smoke), have any other medical conditions, or are breastfeeding. Do not breastfeed during treatment with EMPLICITI, POMALYST and dexamethasone—it is not known if EMPLICITI and POMALYST pass into breast milk and can harm the baby.
If you have liver problems.
If you have kidney problems and are receiving hemodialysis treatment.
Have an infection.

Are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, POMALYST may cause birth defects or death to an unborn baby. Have any other medical conditions.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. POMALYST and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines.

How should I take POMALYST?
Take POMALYST exactly as prescribed and follow all the instructions of the POMALYST REMS program.

Swallow POMALYST capsules whole with water 1 time a day. Do not break, chew, or open capsules.

Take POMALYST at the same time each day with or without food.

If you are on hemodialysis, take POMALYST after hemodialysis on hemodialysis days.
Do not open POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.

If you miss a dose of POMALYST and it has been less than 12 hours since your regular time, take POMALYST as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

If you take too much POMALYST, call your healthcare provider (HCP) right away.
Do not share POMALYST with other people. It may cause birth defects and other serious problems.

What are the possible side effects of EMPLICITI and POMALYST®?

See “What is the most important information I should know about POMALYST?”
EMPLICITI and POMALYST can cause serious side effects, including low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked by your healthcare provider (HCP) weekly for the first 8 weeks of treatment and monthly after that.

Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with EMPLICITI and POMALYST. Tell your HCP right away if you develop any of the following symptoms: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; color changes in your stool; pain or swelling on the upper right side of your stomach area (abdomen); confusion; bleeding or bruising more easily than normal, or feeling very tired.

Infusion Reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, chest pain, trouble breathing, dizziness, or light-headedness.

Infections. Those receiving EMPLICITI with POMALYST® and dexamethasone may develop infections; some can be serious. Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash. Severe allergic and severe skin reactions can happen with POMALYST and may cause death.

Dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.

Nerve damage. Stop taking POMALYST and call your HCP if you develop numbness, tingling, pain, or a burning sensation in your hands, legs, or feet.

New cancers (malignancies). New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Those receiving EMPLICITI with POMALYST and dexamethasone have a risk of developing new cancers. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI, POMALYST and dexamethasone. Talk with your HCP about your risk of developing new cancers.

Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS.

The most common side effects of EMPLICITI when used with POMALYST and dexamethasone include constipation and high blood sugar.

The most common side effects of POMALYST include tiredness and weakness, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infection, back pain, and fever.

These are not all the possible side effects of EMPLICITI and POMALYST®. Your HCP may tell you to stop taking POMALYST if you develop certain serious side effects during treatment. Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read EMPLICITI Full Prescribing Information and Patient Information on this website. Please read POMALYST Full Prescribing Information, including Boxed WARNINGS and Medication Guide on this website.

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine, taken along with the medicines POMALYST (pomalidomide) and dexamethasone used to treat adults with multiple myeloma who have received at least two prior treatments including lenalidomide and a proteasome inhibitor.

What is POMALYST® (pomalidomide)?
POMALYST is a prescription medicine, taken along with the medicine dexamethasone, used to treat adults with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment.

It is not known if EMPLICITI or POMALYST is safe and effective in children.

© 2021 Bristol-Myers Squibb Company. All rights reserved.
US-EMP-21-0005 02/21

I get along great with the doctors and the nurses. The nurses I see regularly are so supportive. They talk to me about their families, how their new babies are doing, their kids... and whenever I see one of my doctors, she always gives me the thumbs up. I respect them, I think they’re great, I think they’re brilliant, and I feel like my clinic is nearly a home away from home. I couldn’t ask for a better team of nurses and doctors.

My best friend Wade really helped me through my diagnosis and treatment. He supports me and makes me laugh along the way. We talk and laugh, even when we are sitting in the waiting room for my treatments. We have a good time together as friends. That’s always been our normal routine, so that’s what makes me feel the most comfortable through it all. I don’t know what I’d have done without having Wade by my side.

Wade, Angela's caregiver

Wade’s story

ANGELA’S CAREGIVER

I believe it’s my job to hold her up whenever she needs me to. She’s done the same for me for years, so it was just something I did without even thinking about it.

Read more about Angela’s story

I get along great with the doctors and the nurses. The nurses I see regularly are so supportive. They talk to me about their families, how their new babies are doing, their kids... and whenever I see one of my doctors, she always gives me the thumbs up. I respect them, I think they’re great, I think they’re brilliant, and I feel like my clinic is nearly a home away from home. I couldn’t ask for a better team of nurses and doctors.

My best friend Wade really helped me through my diagnosis and treatment. He supports me and makes me laugh along the way. We talk and laugh, even when we are sitting in the waiting room for my treatments. We have a good time together as friends. That’s always been our normal routine, so that’s what makes me feel the most comfortable through it all. I don’t know what I’d have done without having Wade by my side.

Wade, Angela's caregiver

Wade’s story

ANGELA’S CAREGIVER

I believe it’s my job to hold her up whenever she needs me to. She’s done the same for me for years, so it was just something I did without even thinking about it.

Angela shares how EMPLICITI and her best friend Wade helped her through her journey.

After you watch the video, learn more about how to receive EMPLICITI.

Angela receives EMPLICITI + REVLIMID® (lenalidomide) + dexamethasone

Voice Over:

“Grandma, catch me.”

Angela:

When I got the call from the physician that I had cancer, I remember sitting at my desk and tears rolling down my cheeks. It was a shock. That you just, you just sit there and think how did I get cancer? And then I thought what do I do now? I was terrified. And all of a sudden, you feel very alone. I was in hopes that this could be a cancer that maybe I could have chemo and, and go through that and, and get better. And I found out it didn’t work that easily. I got real emotional and said this is me, this is my life. I’m by myself and knowing I had a great family, but I felt like no one really understood what it was really feeling like to me, and I didn’t know how to explain it. You got to toughen up. You got to get strong because you’re gonna fight this. And that’s where I set my mind from that day forward. I was in remission for 3 years, drug free, and I had to go back for a yearly exam. And they checked the blood, urine, everything, and the doctor told me that, “Angela, the cancer is coming back.” Immediately, your heart just kind of drops and I just, I thought I just don’t know if I have the strength to go through all that again. And then, I felt sorrier for Wade because he looked so shocked.

Wade:

I did not do as well at that appointment as I did at follow-up appointments where I would pay attention because they would say something to her, and I, I would think I got to listen to this because in 2 or 3 hours she’s gonna remember this and she’s gonna want answers and I got to pay attention.

Angela:

He really got me through it. I don’t know what I would have done without having him. Wade and I talked about it and I discussed it with my son, and he said, “Well mom, I know it’s kind of scary, but,” he said, “it could be great, it could help.” And I said, “Well that sounds like the best thing right now, so I guess we should kind of give it a chance.” I started with EMPLICITI in combination with REVLIMID and dexamethasone.

Voice Over:

EMPLICITI® (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines Revlimid® also known as lenalidomide and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

It is not known if EMPLICITI is safe and effective in children.

SELECTED IMPORTANT SAFETY INFORMATION FOR EMPLICITI® (elotuzumab) and REVLIMID® (lenalidomide) EMPLICITI in combination with REVLIMID and dexamethasone may cause the following serious side effects: infusion reactions, infections, risk of developing new cancers (malignancies), liver problems. There are also other serious risks (Boxed WARNINGS) associated with REVLIMID. REVLIMID can cause harm to unborn babies and blood clots. REVLIMID can also cause low blood counts. REVLIMID is only available through the REVLIMID REMS® program. More information on the REMS program is available at www.CelgeneRiskManagement.com or by calling 1-888-423-5436. Please listen to the Important Safety Information at the end of this video, including more information about serious side effects. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI with REVLIMID and dexamethasone.

Angela:

The nurses and the doctors make you feel so special. They get to know us. They give us hugs. And look forward to seeing me in 2 weeks. I do things with my grandkids. I can stay with them and keep them and do for them. Don’t feel bad if you ever have fear, scared of what tomorrow holds, because we all do. You let your feelings out, you cry, you get angry sometimes, whatever you feel, but then you’ve, you’ve got to come back and be strong.

Wade:

She made up her mind that she was going to fight this. That was her goal. That never wavered.

Voice Over:

This is important information that you need to know about EMPLICITI and REVLIMID. Your healthcare team can work with you to help answer any questions you may have about EMPLICITI and REVLIMID.

WARNINGS FOR REVLIMID: Risk to unborn babies, risk of low blood counts and blood clots.

What is the most important information I should know about REVLIMID?

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID, your healthcare provider (HCP) will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form. REVLIMID can cause serious side effects, including possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take REVLIMID. REVLIMID is similar to the medicine thalidomide, which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. Females must not get pregnant for at least 4 weeks before starting REVLIMID, while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, for at least 4 weeks after stopping REVLIMID.

Females who can become pregnant will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.

Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.

Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after treatment with REVLIMID. If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and Celgene Corporation at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID.
Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.

Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects. Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects.

Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.

Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take REVLIMID. Most people who take REVLIMID will also take a blood thinner medicine to help prevent blood clots. Before taking REVLIMID, tell your healthcare provider if you have had a blood clot in the past; if you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia); about all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID. Signs or symptoms of a blood clot in the lung, arm, or leg may include shortness of breath, chest pain, or arm or leg swelling. Signs or symptoms of a heart attack may include chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.

Signs or symptoms of stroke may include sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.

A red, itchy skin rash, peeling of your skin or blisters, severe itching, fever.

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID: swelling of your lips, mouth, tongue, or throat, trouble breathing or swallowing, raised red areas on your skin (hives), a very fast heartbeat, you feel dizzy or faint.

Who should not take REVLIMID?
Do not take REVLIMID if you are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. See “What is the most important information I should know about REVLIMID?” Are allergic to lenalidomide or any of the ingredients in REVLIMID.

What should I tell my healthcare provider (HCP) before taking EMPLICITI or REVLIMID?
Before you take EMPLICITI or REVLIMID, tell your healthcare provider about all of your medical conditions, including if you have liver problems, have kidney problems or receive hemodialysis treatment, have thyroid problems, have an infection, have had a serious skin rash with thalidomide treatment. You should not take REVLIMID. Are lactose intolerant. REVLIMID contains lactose. Are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby. Are breastfeeding. Do not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID?
Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program. Swallow REVLIMID capsules whole with water 1 time a day. Do not break, chew, or open your capsules. REVLIMID may be taken with or without food. Take REVLIMID at the same time each day. Do not open REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body right away with soap and water. If you miss a dose of REVLIMID and it has been less than 12 hours since your regular time, take REVLIMID as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

If you take too much REVLIMID, call your HCP right away. Do not share REVLIMID with other people. It may cause birth defects and other serious problems.

What are the possible side effects of EMPLICITI and REVLIMID?
See “What is the most important information I should know about REVLIMID?” EMPLICITI and REVLIMID can cause serious side effects, including increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.

Infusion Reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, chest pain, trouble breathing, dizziness, or light-headedness.

Infections. Those receiving EMPLICITI with REVLIMID and dexamethasone may develop infections; some can be serious. Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash. Severe allergic and severe skin reactions can happen with REVLIMID and may cause death.

Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs. Those receiving EMPLICITI with REVLIMID and dexamethasone also have a risk of developing new cancers. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI with REVLIMID and dexamethasone. Talk with your HCP about your risk of developing new cancers.

Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with EMPLICITI and REVLIMID. Tell your HCP right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; color changes in your stool; pain or swelling on the upper right side of your stomach area (abdomen); confusion; bleeding or bruising more easily than normal, or feeling very tired.

Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS while taking REVLIMID. Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender swollen lymph nodes; low-grade fever, pain or rash.

Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.

Risk of early death in MCL. In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of EMPLICITI when used with REVLIMID and dexamethasone include fatigue, diarrhea, fever, constipation, cough, numbness, weakness, tingling, or burning pain in your arms or legs, sore throat or runny nose, upper respiratory tract infection, decreased appetite, and pneumonia.

The most common side effects of REVLIMID include diarrhea, rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet and skin, sleep problems (insomnia), headache, muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of a cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed, shaking or trembling (tremor), joint aches, and pain in your back or stomach-area (abdomen).

These are not all the possible side effects of EMPLICITI and REVLIMID. Your HCP may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

What is REVLIMID® (lenalidomide)?
REVLIMID is a prescription medicine used to treat adults with multiple myeloma in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

It is not known if EMPLICITI or REVLIMID is safe and effective in children.

Please read the Patient Information in the full Prescribing Information for EMPLICITI, and the Medication Guide in the full Prescribing Information for REVLIMID, including Boxed WARNINGS, on this website.

© 2021 Bristol-Myers Squibb Company. All rights reserved.
US-EMP-21-0003 02/21

Watch Video
Fullscreen

View Video Transcript

Voice Over:

“Grandma, catch me.”

Angela:

When I got the call from the physician that I had cancer, I remember sitting at my desk and tears rolling down my cheeks. It was a shock. That you just, you just sit there and think how did I get cancer? And then I thought what do I do now? I was terrified. And all of a sudden, you feel very alone. I was in hopes that this could be a cancer that maybe I could have chemo and, and go through that and, and get better. And I found out it didn’t work that easily. I got real emotional and said this is me, this is my life. I’m by myself and knowing I had a great family, but I felt like no one really understood what it was really feeling like to me, and I didn’t know how to explain it. You got to toughen up. You got to get strong because you’re gonna fight this. And that’s where I set my mind from that day forward. I was in remission for 3 years, drug free, and I had to go back for a yearly exam. And they checked the blood, urine, everything, and the doctor told me that, “Angela, the cancer is coming back.” Immediately, your heart just kind of drops and I just, I thought I just don’t know if I have the strength to go through all that again. And then, I felt sorrier for Wade because he looked so shocked.

Wade:

I did not do as well at that appointment as I did at follow-up appointments where I would pay attention because they would say something to her, and I, I would think I got to listen to this because in 2 or 3 hours she’s gonna remember this and she’s gonna want answers and I got to pay attention.

Angela:

He really got me through it. I don’t know what I would have done without having him. Wade and I talked about it and I discussed it with my son, and he said, “Well mom, I know it’s kind of scary, but,” he said, “it could be great, it could help.” And I said, “Well that sounds like the best thing right now, so I guess we should kind of give it a chance.” I started with EMPLICITI in combination with REVLIMID and dexamethasone.

Voice Over:

EMPLICITI® (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines Revlimid® also known as lenalidomide and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

It is not known if EMPLICITI is safe and effective in children.

SELECTED IMPORTANT SAFETY INFORMATION FOR EMPLICITI® (elotuzumab) and REVLIMID® (lenalidomide) EMPLICITI in combination with REVLIMID and dexamethasone may cause the following serious side effects: infusion reactions, infections, risk of developing new cancers (malignancies), liver problems. There are also other serious risks (Boxed WARNINGS) associated with REVLIMID. REVLIMID can cause harm to unborn babies and blood clots. REVLIMID can also cause low blood counts. REVLIMID is only available through the REVLIMID REMS® program. More information on the REMS program is available at www.CelgeneRiskManagement.com or by calling 1-888-423-5436. Please listen to the Important Safety Information at the end of this video, including more information about serious side effects. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI with REVLIMID and dexamethasone.

Angela:

The nurses and the doctors make you feel so special. They get to know us. They give us hugs. And look forward to seeing me in 2 weeks. I do things with my grandkids. I can stay with them and keep them and do for them. Don’t feel bad if you ever have fear, scared of what tomorrow holds, because we all do. You let your feelings out, you cry, you get angry sometimes, whatever you feel, but then you’ve, you’ve got to come back and be strong.

Wade:

She made up her mind that she was going to fight this. That was her goal. That never wavered.

Voice Over:

This is important information that you need to know about EMPLICITI and REVLIMID. Your healthcare team can work with you to help answer any questions you may have about EMPLICITI and REVLIMID.

WARNINGS FOR REVLIMID: Risk to unborn babies, risk of low blood counts and blood clots.

What is the most important information I should know about REVLIMID?

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID, your healthcare provider (HCP) will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form. REVLIMID can cause serious side effects, including possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take REVLIMID. REVLIMID is similar to the medicine thalidomide, which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. Females must not get pregnant for at least 4 weeks before starting REVLIMID, while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, for at least 4 weeks after stopping REVLIMID.

Females who can become pregnant will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.

Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.

Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after treatment with REVLIMID. If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and Celgene Corporation at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID.
Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.

Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects. Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects.

Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.

Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take REVLIMID. Most people who take REVLIMID will also take a blood thinner medicine to help prevent blood clots. Before taking REVLIMID, tell your healthcare provider if you have had a blood clot in the past; if you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia); about all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID. Signs or symptoms of a blood clot in the lung, arm, or leg may include shortness of breath, chest pain, or arm or leg swelling. Signs or symptoms of a heart attack may include chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.

Signs or symptoms of stroke may include sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.

A red, itchy skin rash, peeling of your skin or blisters, severe itching, fever.

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID: swelling of your lips, mouth, tongue, or throat, trouble breathing or swallowing, raised red areas on your skin (hives), a very fast heartbeat, you feel dizzy or faint.

Who should not take REVLIMID?
Do not take REVLIMID if you are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. See “What is the most important information I should know about REVLIMID?” Are allergic to lenalidomide or any of the ingredients in REVLIMID.

What should I tell my healthcare provider (HCP) before taking EMPLICITI or REVLIMID?
Before you take EMPLICITI or REVLIMID, tell your healthcare provider about all of your medical conditions, including if you have liver problems, have kidney problems or receive hemodialysis treatment, have thyroid problems, have an infection, have had a serious skin rash with thalidomide treatment. You should not take REVLIMID. Are lactose intolerant. REVLIMID contains lactose. Are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby. Are breastfeeding. Do not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID?
Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program. Swallow REVLIMID capsules whole with water 1 time a day. Do not break, chew, or open your capsules. REVLIMID may be taken with or without food. Take REVLIMID at the same time each day. Do not open REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body right away with soap and water. If you miss a dose of REVLIMID and it has been less than 12 hours since your regular time, take REVLIMID as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

If you take too much REVLIMID, call your HCP right away. Do not share REVLIMID with other people. It may cause birth defects and other serious problems.

What are the possible side effects of EMPLICITI and REVLIMID?
See “What is the most important information I should know about REVLIMID?” EMPLICITI and REVLIMID can cause serious side effects, including increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.

Infusion Reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, chest pain, trouble breathing, dizziness, or light-headedness.

Infections. Those receiving EMPLICITI with REVLIMID and dexamethasone may develop infections; some can be serious. Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash. Severe allergic and severe skin reactions can happen with REVLIMID and may cause death.

Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs. Those receiving EMPLICITI with REVLIMID and dexamethasone also have a risk of developing new cancers. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI with REVLIMID and dexamethasone. Talk with your HCP about your risk of developing new cancers.

Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with EMPLICITI and REVLIMID. Tell your HCP right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; color changes in your stool; pain or swelling on the upper right side of your stomach area (abdomen); confusion; bleeding or bruising more easily than normal, or feeling very tired.

Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS while taking REVLIMID. Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender swollen lymph nodes; low-grade fever, pain or rash.

Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.

Risk of early death in MCL. In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of EMPLICITI when used with REVLIMID and dexamethasone include fatigue, diarrhea, fever, constipation, cough, numbness, weakness, tingling, or burning pain in your arms or legs, sore throat or runny nose, upper respiratory tract infection, decreased appetite, and pneumonia.

The most common side effects of REVLIMID include diarrhea, rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet and skin, sleep problems (insomnia), headache, muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of a cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed, shaking or trembling (tremor), joint aches, and pain in your back or stomach-area (abdomen).

These are not all the possible side effects of EMPLICITI and REVLIMID. Your HCP may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

What is REVLIMID® (lenalidomide)?
REVLIMID is a prescription medicine used to treat adults with multiple myeloma in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

It is not known if EMPLICITI or REVLIMID is safe and effective in children.

Please read the Patient Information in the full Prescribing Information for EMPLICITI, and the Medication Guide in the full Prescribing Information for REVLIMID, including Boxed WARNINGS, on this website.

© 2021 Bristol-Myers Squibb Company. All rights reserved.
US-EMP-21-0003 02/21

When I was first diagnosed, I thought I had a torn rotator cuff. It turned out that I had multiple myeloma. Here I am, 41 years old, wife and two kids, and a relatively active life. There was a lot of fear, a lot of anxiety, a lot of uncertainty around what was going to happen and what the future held for my family and myself.

What’s important is what you have around you and the attitude that you take. I had a very positive attitude, and I still do, and that was very important to me. I think it helped me get through a lot. I made one promise to both my kids, and that’s that I would be honest with them. I think that honesty helped them understand that they were part of this, that they could be a part of this journey that we were going to be on as a family, and that they could ask me any questions.

Dana, Randy's wife

Dana’s story

RANDY’S WIFE

Having a loved one with multiple myeloma and being the person that takes care of them changes a person, and it’s not always negative. Just like the person with multiple myeloma looks at things differently, so does the caregiver. I look at things daily through a different lens. I’m thankful every day for the things that I was not thankful for before, just the little things that you’re happy for that before didn’t matter. Since Randy’s been diagnosed, he inspires me every day—being able to deal with how he was feeling, and still being there for our kids and myself.

Read more about Randy’s story

When I was first diagnosed, I thought I had a torn rotator cuff. It turned out that I had multiple myeloma. Here I am, 41 years old, wife and two kids, and a relatively active life. There was a lot of fear, a lot of anxiety, a lot of uncertainty around what was going to happen and what the future held for my family and myself.

What’s important is what you have around you and the attitude that you take. I had a very positive attitude, and I still do, and that was very important to me. I think it helped me get through a lot. I made one promise to both my kids, and that’s that I would be honest with them. I think that honesty helped them understand that they were part of this, that they could be a part of this journey that we were going to be on as a family, and that they could ask me any questions.

Dana, Randy's wife

Dana’s story

RANDY’S WIFE

Having a loved one with multiple myeloma and being the person that takes care of them changes a person, and it’s not always negative. Just like the person with multiple myeloma looks at things differently, so does the caregiver. I look at things daily through a different lens. I’m thankful every day for the things that I was not thankful for before, just the little things that you’re happy for that before didn’t matter. Since Randy’s been diagnosed, he inspires me every day—being able to deal with how he was feeling, and still being there for our kids and myself.

Randy shares his experiences with multiple myeloma and EMPLICITI.

After you watch the video, learn more about how to receive EMPLICITI.

Randy receives EMPLICITI + REVLIMID® (lenalidomide) + dexamethasone

Randy:

I was probably in the best shape since I was in high school. I was running five miles a day. I was playing basketball. I was playing softball, just really kind of enjoying life, and you know, one day everything kind of changed, and I remember the day that my son and I were playing basketball in the driveway, you know... So we were having a little dunk contest and I hurt my shoulder on one of them. It felt just like it felt in college when I had a rotator cuff injury playing baseball. So, that’s what I thought it was, but it was actually bone pain caused by the disease that was manifesting itself in my body at the time. Finding out was–it was just something that you never expect. You never expect to hear cancer. It actually happened to be multiple myeloma. There was a lot of fear, a lot of anxiety, a lot of tears shed that night as well, a lot of uncertainty around, you know, what was going to happen and what the future kind of held for my family and myself. I knew in the back of my mind that I was always going to have this multiple myeloma. It was always going to be hanging over my head, and I always wanted to know what was next if it came back and what were my options if it came back. I would walk in with a page of questions. This is how I’m feeling. This is something I read. This is something I did. This is something I looked at, and oh, I was looking at clinical trials. Do you think I would be a candidate for a clinical trial going in and doing this…I started reading a little bit about EMPLICITI online and some of the things that it offered, and I had a conversation a couple of times with my oncologist, and EMPLICITI is the one that she felt was the appropriate one for me.

Voice Over:

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine, taken along with the medicines REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

It is not known if EMPLICITI or REVLIMID is safe and effective in children.

SELECTED IMPORTANT SAFETY INFORMATION FOR EMPLICITI® (elotuzumab) and REVLIMID® (lenalidomide)

EMPLICITI in combination with REVLIMID and dexamethasone may cause the following serious side effects: infusion reactions, infections, risk of developing new cancers (malignancies), liver problems. There are also other serious risks (Boxed WARNINGS) associated with REVLIMID. REVLIMID can cause harm to unborn babies and blood clots. REVLIMID can also cause low blood counts. REVLIMID is only available through the REVLIMID REMS® program. More information on the REMS program is available at www.CelgeneRiskManagement.com or by calling 1-888-423-5436. Please listen to the Important Safety Information at the end of this video, including more information about serious side effects. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI with REVLIMID and dexamethasone.

Dana:

Since Randy's been diagnosed, he inspires me every day–being able to deal with how he was feeling, still being there for our kids and myself, so he inspired me to be a better mother, wife, and friend to him overall.

Randy:

I feel so blessed in so many ways to have the family that I do and the support system around me that I do. You always hear so many things about multiple myeloma, and there’s no cure and it’s going to come back and you’re going to battle it again someday, and I know that and I’m okay with that. I think I’m a stronger person today, and that’s because of my family, that’s because of my friends. They’ve given me the ability to really just be who I am and who I should be. I can go to my son’s basketball games, baseball games without worrying about whether I’m going to have to run off because I’m not feeling well. I can go to my daughter’s concerts, her plays, without having to worry about man, it’s going to be two hours, and am I going to make it through it. I can just go and enjoy it and that’s great.

Voiceover:

His doctor discussed the potential side effects with him.

Randy:

Everything about life is different. There is nothing that I view in that same lens that I did three years ago. It just–it profoundly changes you. You appreciate every day that you have, and because there was a time when I wasn’t sure that I’d have tomorrow, so I love today. Today’s a great day because I’m here, and if tomorrow happens, tomorrow will be a great day, too because I’ll still be there.

Voiceover:

This is important information that you need to know about EMPLICITI and REVLIMID. Your healthcare team can work with you to help answer any questions you may have about EMPLICITI and REVLIMID.

WARNINGS FOR REVLIMID: Risk to unborn babies, risk of low blood counts and blood clots.

What is the most important information I should know about REVLIMID?
Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID, your healthcare provider (HCP) will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form.

REVLIMID can cause serious side effects, including possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take REVLIMID.

REVLIMID is similar to the medicine thalidomide, which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. Females must not get pregnant for at least 4 weeks before starting REVLIMID, while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, for at least 4 weeks after stopping REVLIMID.

Females who can become pregnant will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.

Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.

Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after treatment with REVLIMID.

If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and Celgene Corporation at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID.

Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.

Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects.

Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.

Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take REVLIMID. Most people who take REVLIMID will also take a blood thinner medicine to help prevent blood clots. Before taking REVLIMID, tell your healthcare provider if you have had a blood clot in the past; if you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia); and about all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID. Signs or symptoms of a blood clot in the lung, arm, or leg may include shortness of breath, chest pain, or arm or leg swelling. Signs or symptoms of a heart attack may include chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.

Signs or symptoms of stroke may include sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.

A red, itchy skin rash, peeling of your skin or blisters, severe itching, fever.

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID: swelling of your lips, mouth, tongue, or throat, trouble breathing or swallowing, raised red areas on your skin (hives), a very fast heartbeat, or you feel dizzy or faint.

Who should not take REVLIMID?

Do not take REVLIMID if you are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. See “What is the most important information I should know about REVLIMID?” Are allergic to lenalidomide or any of the ingredients in REVLIMID.

What should I tell my healthcare provider (HCP) before taking EMPLICITI or REVLIMID?

Before you take EMPLICITI or REVLIMID, tell your healthcare provider about all of your medical conditions, including if you have liver problems, have kidney problems or receive hemodialysis treatment, have thyroid problems, have an infection, have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.

Are lactose intolerant. REVLIMID contains lactose. Are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby. Are breastfeeding. Do not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID?

Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program. Swallow REVLIMID capsules whole with water 1 time a day. Do not break, chew, or open your capsules. REVLIMID may be taken with or without food. Take REVLIMID at the same time each day. Do not open REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body right away with soap and water. If you miss a dose of REVLIMID and it has been less than 12 hours since your regular time, take REVLIMID as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

If you take too much REVLIMID, call your HCP right away.

Do not share REVLIMID with other people. It may cause birth defects and other serious problems.

What are the possible side effects of EMPLICITI and REVLIMID?

See “What is the most important information I should know about REVLIMID?” EMPLICITI and REVLIMID can cause serious side effects, including increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.

Infusion Reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, chest pain, trouble breathing, dizziness, or light-headedness.

Infections. Those receiving EMPLICITI with REVLIMID and dexamethasone may develop infections; some can be serious. Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash. Severe allergic and severe skin reactions can happen with REVLIMID and may cause death.

Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs. Those receiving EMPLICITI with REVLIMID and dexamethasone also have a risk of developing new cancers. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI with REVLIMID and dexamethasone. Talk with your HCP about your risk of developing new cancers.

Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with EMPLICITI and REVLIMID. Tell your HCP right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; color changes in your stool; pain or swelling on the upper right side of your stomach area (abdomen); confusion; bleeding or bruising more easily than normal, or feeling very tired.

Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS while taking REVLIMID.

Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender swollen lymph nodes; low-grade fever, pain or rash.

Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.

Risk of early death in MCL. In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of EMPLICITI when used with REVLIMID and dexamethasone include fatigue, diarrhea, fever, constipation, cough, numbness, weakness, tingling, or burning pain in your arms or legs, sore throat or runny nose, upper respiratory tract infection, decreased appetite, and pneumonia.

The most common side effects of REVLIMID include diarrhea, rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet and skin, sleep problems (insomnia), headache, muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of a cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed, shaking or trembling (tremor), joint aches, and pain in your back or stomach-area (abdomen).

These are not all the possible side effects of EMPLICITI and REVLIMID. Your HCP may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

What is REVLIMID® (lenalidomide)?
REVLIMID is a prescription medicine used to treat adults with multiple myeloma in combination with the medicine dexamethasone, or as a maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

It is not known if EMPLICITI or REVLIMID is safe and effective in children.

Please read the Patient Information in the full Prescribing Information for EMPLICITI, and the Medication Guide in the full Prescribing Information for REVLIMID, including Boxed WARNINGS, on this website.

© 2021 Bristol-Myers Squibb Company. All rights reserved.
US-EMP-21-0004 02/21

Watch Video
Fullscreen

View Video Transcript

Randy:

I was probably in the best shape since I was in high school. I was running five miles a day. I was playing basketball. I was playing softball, just really kind of enjoying life, and you know, one day everything kind of changed, and I remember the day that my son and I were playing basketball in the driveway, you know... So we were having a little dunk contest and I hurt my shoulder on one of them. It felt just like it felt in college when I had a rotator cuff injury playing baseball. So, that’s what I thought it was, but it was actually bone pain caused by the disease that was manifesting itself in my body at the time. Finding out was–it was just something that you never expect. You never expect to hear cancer. It actually happened to be multiple myeloma. There was a lot of fear, a lot of anxiety, a lot of tears shed that night as well, a lot of uncertainty around, you know, what was going to happen and what the future kind of held for my family and myself. I knew in the back of my mind that I was always going to have this multiple myeloma. It was always going to be hanging over my head, and I always wanted to know what was next if it came back and what were my options if it came back. I would walk in with a page of questions. This is how I’m feeling. This is something I read. This is something I did. This is something I looked at, and oh, I was looking at clinical trials. Do you think I would be a candidate for a clinical trial going in and doing this…I started reading a little bit about EMPLICITI online and some of the things that it offered, and I had a conversation a couple of times with my oncologist, and EMPLICITI is the one that she felt was the appropriate one for me.

Voice Over:

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine, taken along with the medicines REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

It is not known if EMPLICITI or REVLIMID is safe and effective in children.

SELECTED IMPORTANT SAFETY INFORMATION FOR EMPLICITI® (elotuzumab) and REVLIMID® (lenalidomide)

EMPLICITI in combination with REVLIMID and dexamethasone may cause the following serious side effects: infusion reactions, infections, risk of developing new cancers (malignancies), liver problems. There are also other serious risks (Boxed WARNINGS) associated with REVLIMID. REVLIMID can cause harm to unborn babies and blood clots. REVLIMID can also cause low blood counts. REVLIMID is only available through the REVLIMID REMS® program. More information on the REMS program is available at www.CelgeneRiskManagement.com or by calling 1-888-423-5436. Please listen to the Important Safety Information at the end of this video, including more information about serious side effects. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI with REVLIMID and dexamethasone.

Dana:

Since Randy's been diagnosed, he inspires me every day–being able to deal with how he was feeling, still being there for our kids and myself, so he inspired me to be a better mother, wife, and friend to him overall.

Randy:

I feel so blessed in so many ways to have the family that I do and the support system around me that I do. You always hear so many things about multiple myeloma, and there’s no cure and it’s going to come back and you’re going to battle it again someday, and I know that and I’m okay with that. I think I’m a stronger person today, and that’s because of my family, that’s because of my friends. They’ve given me the ability to really just be who I am and who I should be. I can go to my son’s basketball games, baseball games without worrying about whether I’m going to have to run off because I’m not feeling well. I can go to my daughter’s concerts, her plays, without having to worry about man, it’s going to be two hours, and am I going to make it through it. I can just go and enjoy it and that’s great.

Voiceover:

His doctor discussed the potential side effects with him.

Randy:

Everything about life is different. There is nothing that I view in that same lens that I did three years ago. It just–it profoundly changes you. You appreciate every day that you have, and because there was a time when I wasn’t sure that I’d have tomorrow, so I love today. Today’s a great day because I’m here, and if tomorrow happens, tomorrow will be a great day, too because I’ll still be there.

Voiceover:

This is important information that you need to know about EMPLICITI and REVLIMID. Your healthcare team can work with you to help answer any questions you may have about EMPLICITI and REVLIMID.

WARNINGS FOR REVLIMID: Risk to unborn babies, risk of low blood counts and blood clots.

What is the most important information I should know about REVLIMID?
Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID, your healthcare provider (HCP) will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form.

REVLIMID can cause serious side effects, including possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take REVLIMID.

REVLIMID is similar to the medicine thalidomide, which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. Females must not get pregnant for at least 4 weeks before starting REVLIMID, while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, for at least 4 weeks after stopping REVLIMID.

Females who can become pregnant will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.

Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.

Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after treatment with REVLIMID.

If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and Celgene Corporation at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID.

Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.

Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects.

Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.

Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take REVLIMID. Most people who take REVLIMID will also take a blood thinner medicine to help prevent blood clots. Before taking REVLIMID, tell your healthcare provider if you have had a blood clot in the past; if you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia); and about all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID. Signs or symptoms of a blood clot in the lung, arm, or leg may include shortness of breath, chest pain, or arm or leg swelling. Signs or symptoms of a heart attack may include chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.

Signs or symptoms of stroke may include sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.

A red, itchy skin rash, peeling of your skin or blisters, severe itching, fever.

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID: swelling of your lips, mouth, tongue, or throat, trouble breathing or swallowing, raised red areas on your skin (hives), a very fast heartbeat, or you feel dizzy or faint.

Who should not take REVLIMID?

Do not take REVLIMID if you are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. See “What is the most important information I should know about REVLIMID?” Are allergic to lenalidomide or any of the ingredients in REVLIMID.

What should I tell my healthcare provider (HCP) before taking EMPLICITI or REVLIMID?

Before you take EMPLICITI or REVLIMID, tell your healthcare provider about all of your medical conditions, including if you have liver problems, have kidney problems or receive hemodialysis treatment, have thyroid problems, have an infection, have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.

Are lactose intolerant. REVLIMID contains lactose. Are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby. Are breastfeeding. Do not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID?

Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program. Swallow REVLIMID capsules whole with water 1 time a day. Do not break, chew, or open your capsules. REVLIMID may be taken with or without food. Take REVLIMID at the same time each day. Do not open REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body right away with soap and water. If you miss a dose of REVLIMID and it has been less than 12 hours since your regular time, take REVLIMID as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

If you take too much REVLIMID, call your HCP right away.

Do not share REVLIMID with other people. It may cause birth defects and other serious problems.

What are the possible side effects of EMPLICITI and REVLIMID?

See “What is the most important information I should know about REVLIMID?” EMPLICITI and REVLIMID can cause serious side effects, including increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.

Infusion Reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, chest pain, trouble breathing, dizziness, or light-headedness.

Infections. Those receiving EMPLICITI with REVLIMID and dexamethasone may develop infections; some can be serious. Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash. Severe allergic and severe skin reactions can happen with REVLIMID and may cause death.

Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs. Those receiving EMPLICITI with REVLIMID and dexamethasone also have a risk of developing new cancers. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI with REVLIMID and dexamethasone. Talk with your HCP about your risk of developing new cancers.

Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with EMPLICITI and REVLIMID. Tell your HCP right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; color changes in your stool; pain or swelling on the upper right side of your stomach area (abdomen); confusion; bleeding or bruising more easily than normal, or feeling very tired.

Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS while taking REVLIMID.

Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender swollen lymph nodes; low-grade fever, pain or rash.

Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.

Risk of early death in MCL. In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of EMPLICITI when used with REVLIMID and dexamethasone include fatigue, diarrhea, fever, constipation, cough, numbness, weakness, tingling, or burning pain in your arms or legs, sore throat or runny nose, upper respiratory tract infection, decreased appetite, and pneumonia.

The most common side effects of REVLIMID include diarrhea, rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet and skin, sleep problems (insomnia), headache, muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of a cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed, shaking or trembling (tremor), joint aches, and pain in your back or stomach-area (abdomen).

These are not all the possible side effects of EMPLICITI and REVLIMID. Your HCP may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is EMPLICITI® (elotuzumab)?
EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.

What is REVLIMID® (lenalidomide)?
REVLIMID is a prescription medicine used to treat adults with multiple myeloma in combination with the medicine dexamethasone, or as a maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

It is not known if EMPLICITI or REVLIMID is safe and effective in children.

Please read the Patient Information in the full Prescribing Information for EMPLICITI, and the Medication Guide in the full Prescribing Information for REVLIMID, including Boxed WARNINGS, on this website.

© 2021 Bristol-Myers Squibb Company. All rights reserved.
US-EMP-21-0004 02/21

US Full Prescribing Information

Important Safety Information and Indications for EMPLICITI®, REVLIMID® (lenalidomide), and
POMALYST® (pomalidomide)

EMPLICITI in combination with REVLIMID and dexamethasone or in combination with POMALYST and dexamethasone may cause the following serious side effects:
Infusion reactions, infections, risk of developing new cancers (malignancies), and liver problems. There are also other serious risks (Boxed WARNINGS) associated with REVLIMID and POMALYST. REVLIMID and POMALYST can cause harm to unborn babies and blood clots. REVLIMID can also cause low blood counts. REVLIMID and POMALYST are only available through the REVLIMID REMS® or POMALYST REMS® programs. More information on the REMS programs is available at www.celgeneriskmanagement.com or by calling 1-888-423-5436. For more safety information, please read the full Important Safety Information below. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI with REVLIMID and dexamethasone or EMPLICITI with POMALYST and dexamethasone.

Important Safety Information and Indications

WARNINGS FOR REVLIMID: Risk to unborn babies, risk of low blood counts and blood clots.

WARNINGS FOR POMALYST: Risk to unborn babies, and blood clots.

What is the most important information I should know about REVLIMID & POMALYST?

Before you begin taking REVLIMID or POMALYST, you must read and agree to all of the instructions in the REVLIMID REMS® or POMALYST REMS® program. Before prescribing REVLIMID or POMALYST, your healthcare provider (HCP) will explain the REVLIMID REMS or POMALYST REMS program to you and have you sign the Patient-Physician Agreement Form.

REVLIMID & POMALYST can cause serious side effects, including:

  • Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take REVLIMID or POMALYST.
    • REVLIMID & POMALYST are similar to the medicine thalidomide (THALOMID®), which is known to cause severe life-threatening birth defects. REVLIMID & POMALYST have not been tested in pregnant females. REVLIMID & POMALYST have harmed unborn animals in animal testing.
    • Females must not get pregnant:
      • For at least 4 weeks before starting REVLIMID or POMALYST
      • While taking REVLIMID or POMALYST
      • During any breaks (interruptions) in your treatment with REVLIMID or POMALYST
      • For at least 4 weeks after stopping REVLIMID or POMALYST
    • Females who can become pregnant:
      • Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.
        If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
      • Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in treatment, and for at least 4 weeks after stopping REVLIMID or POMALYST.
      • Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after treatment with REVLIMID or POMALYST.
    • If you become pregnant while taking REVLIMID or POMALYST, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to:
      • FDA MedWatch at 1-800-FDA-1088
      • Celgene Corporation at 1-888-423-5436
    • There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID or POMALYST during pregnancy, or if their male partner takes REVLIMID or POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.

    • REVLIMID & POMALYST can pass into human semen:
      • Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID or POMALYST, during any breaks (interruptions) in your treatment with REVLIMID or POMALYST, and for 4 weeks after stopping REVLIMID or POMALYST.
      • Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.
      • Do not donate sperm while taking REVLIMID or POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID or POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID or POMALYST and may be born with birth defects.
    • Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

    • Do not donate blood while you take REVLIMID or POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID or POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID or POMALYST and may be born with birth defects.
  • Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.
  • Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take REVLIMID or POMALYST.
    • Most people who take REVLIMID or POMALYST will also take a blood thinner medicine to help prevent blood clots.
    • Before taking REVLIMID or POMALYST, tell your healthcare provider:
      • If you have had a blood clot in the past.
      • If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia).
      • About all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID or POMALYST:

  • Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling.
  • Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty, shortness of breath, feeling sick, or vomiting.
  • Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.
  • A red, itchy skin rash
  • Peeling of your skin or blisters
  • Severe itching
  • Fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID or POMALYST:

  • swelling of your lips, mouth, tongue, or throat
  • trouble breathing or swallowing
  • raised red areas on your skin (hives)
  • a very fast heartbeat
  • you feel dizzy or faint

Who should not take REVLIMID or POMALYST?

Do not take REVLIMID or POMALYST if you:

  • Are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID or POMALYST. See “What is the most important information I should know about REVLIMID & POMALYST?”
  • Are allergic to lenalidomide or pomalidomide or any of the ingredients in REVLIMID or POMALYST.

What should I tell my healthcare provider (HCP) before taking EMPLICITI, REVLIMID, or POMALYST?
Before you take EMPLICITI, REVLIMID, or POMALYST, tell your healthcare provider about all of your medical conditions, including if you:

  • smoke cigarettes (POMALYST may not work as well in people who smoke)
  • have liver problems
  • have kidney problems or receive hemodialysis treatment
  • have thyroid problems
  • have an infection
  • have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
  • are lactose intolerant. REVLIMID contains lactose.
  • are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID & POMALYST may cause birth defects or death of an unborn baby.
  • are breastfeeding. Do not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone or EMPLICITI and POMALYST and dexamethasone.
  • Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines or POMALYST and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID or POMALYST?

Take REVLIMID or POMALYST exactly as prescribed and follow all the instructions of the REVLIMID REMS & POMALYST REMS program.

  • Swallow REVLIMID or POMALYST capsules whole with water 1 time a day. Do not break, chew, or open your capsules.
  • REVLIMID or POMALYST may be taken with or without food.
  • Take REVLIMID or POMALYST at the same time each day.
  • If you are on hemodialysis, take POMALYST after hemodialysis, on hemodialysis days.
  • Do not open REVLIMID or POMALYST capsules or handle them any more than needed. If you touch a broken REVLIMID or POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.
  • If you miss a dose of REVLIMID or POMALYST and it has been less than 12 hours since your regular time, take REVLIMID or POMALYST as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
  • If you take too much REVLIMID or POMALYST, call your HCP right away.
  • Do not share REVLIMID & POMALYST with other people. It may cause birth defects and other serious problems.

What are the possible side effects of EMPLICITI, REVLIMID, and POMALYST?

  • See “What is the most important information I should know about REVLIMID & POMALYST?”
  • EMPLICITI, REVLIMID, and POMALYST can cause serious side effects, including:
    • Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.
    • Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked by your healthcare provider (HCP) weekly for the first 8 weeks of treatment and monthly after that.
    • Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with EMPLICITI, REVLIMID, and POMALYST. Tell your HCP right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white parts of your eyes (jaundice); dark or brown (tea-colored) urine; color changes in your stool; pain or swelling on the upper right side of your stomach area (abdomen); confusion; bleeding or bruising more easily than normal, or feeling very tired.
    • Infusion Reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, chest pain, trouble breathing, dizziness, or light-headedness.
    • Infections. Those receiving EMPLICITI with REVLIMID and dexamethasone or EMPLICITI with POMALYST and dexamethasone may develop infections; some can be serious. Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including: fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash. Severe allergic and severe skin reactions can happen with REVLIMID & POMALYST and may cause death.
    • Dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.
    • Nerve damage. Stop taking POMALYST and call your HCP if you develop numbness, tingling, pain, or a burning sensation in your hands, legs, or feet.
    • Risk of new cancers (malignancies). New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Those receiving EMPLICITI with REVLIMID and dexamethasone or EMPLICITI with POMALYST and dexamethasone have a risk of developing new cancers. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI with REVLIMID and dexamethasone, or EMPLICITI with POMALYST and dexamethasone. Talk with your HCP about your risk of developing new cancers.
    • Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your HCP may do blood tests to check you for TLS.
    • Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender, swollen lymph nodes; low-grade fever, pain or rash.
    • Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.
    • Risk of early death in MCL. In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.
  • The most common side effects of EMPLICITI when used with REVLIMID and dexamethasone include fatigue, diarrhea, fever, constipation, cough, numbness, weakness, tingling, or burning pain in your arms or legs, sore throat or runny nose, upper respiratory tract infection, decreased appetite, and pneumonia.
  • The most common side effects of EMPLICITI when used with POMALYST and dexamethasone include constipation and high blood sugar.
  • The most common side effects of REVLIMID include diarrhea, rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet and skin, sleep problems (insomnia), headache, muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of a cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed, shaking or trembling (tremor), joint aches, and pain in your back or stomach-area (abdomen).
  • The most common side effects of POMALYST include tiredness and weakness, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infection, back pain, and fever.
  • These are not all the possible side effects of EMPLICITI, REVLIMID, and POMALYST. Your HCP may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID or POMALYST if you develop certain serious side effects during treatment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is EMPLICITI® (elotuzumab)?

EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines:

  • REVLIMID® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.
  • POMALYST® (pomalidomide) and dexamethasone in adults who have received at least two prior treatments including REVLIMID and a proteasome inhibitor.

What is REVLIMID® (lenalidomide)?

REVLIMID is a prescription medicine used to treat adults with multiple myeloma in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

What is POMALYST® (pomalidomide)?

POMALYST is a prescription medicine, taken along with the medicine dexamethasone, used to treat adults with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment.