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 Lenalidomide REMS or POMALYST REMS^® program. Further information about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by telephone at 1-888-423-5436. Further information about the POMALYST REMS program is available at www.pomalystrems.com or by telephone at 1-888-423-5436. Before prescribing REVLIMID or POMALYST, your healthcare provider (HCP) will explain the Lenalidomide 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 REMS Call Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to:
    • FDA MedWatch at 1-800-FDA-1088
    • REMS Call Center 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 the REMS Call Center 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 up to 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 Lenalidomide 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 or break 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) can happen with REVLIMID and may cause death. Tell your healthcare provider if you get any of these symptoms of tumor flare reaction during treatment with 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.

It is not known if EMPLICITI, REVLIMID, or POMALYST 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 and POMALYST, including Boxed WARNINGS for REVLIMID and POMALYST.