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WHAT IS EMPLICITI?

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

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

 

image shows 2 women taking a selfie, one of them is identified as Angela B., an EMPLICITI patient
Angela B. 
  • EMPLICITI patient
How was EMPLICITI studied?
 

EMPLICITI (elotuzumab) was studied in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone and was compared with REVLIMID and dexamethasone alone. All patients in the study had received one to three prior multiple myeloma treatments.

image shows EMPLICITI™ (elotuzumab) plus REVLIMID plus dexamethasone

image shows EMPLICITI™ (elotuzumab) plus REVLIMID plus dexamethasone
 
image shows EMPLICITI™ (elotuzumab) plus REVLIMID plus dexamethasone
 
image shows EMPLICITI™ (elotuzumab) plus REVLIMID plus dexamethasone

Selected Important Facts About EMPLICITI

What should I discuss with my healthcare team before starting EMPLICITI?

Talk to your healthcare team about all of your medical conditions, including if you have an infection.

Let your healthcare team know as soon as possible if you are a woman who is pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if EMPLICITI can harm an unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby. It is not known if EMPLICITI passes into breastmilk. You should not breastfeed during treatment with EMPLICITI with REVLIMID and dexamethasone.

Before receiving EMPLICITI with REVLIMID and dexamethasone females and males must agree to the instructions in the REVLIMID REMS® program. The REVLIMID REMS® program has specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know.

Talk to your healthcare team to learn more about REVLIMID.

Interactions with other drugs may affect the way EMPLICITI works in your body.

Talk to your healthcare team about all of the medicines you are taking before starting EMPLICITI, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

Please read other Important Facts below.

image shows a portrait of a man identified as Phillip G., with a woman posing behind him
Phillip G.

How many people were in the study?

What was the main goal of the study?

The study was designed to look at progression-free survival at 2 years. Progression-free survival is the length of time during and after treatment of a disease that a patient lives with the disease but it does not get worse.

The study was also designed to look at the overall response rate. Overall response rate is the percentage of patients who responded to treatment—for example, patients whose level of M protein was lowered by a certain amount. Overall response rates include complete response, very good partial response, and partial response.

The main analysis for progression-free survival took place at 2 years. Patients still benefiting from treatment continued in the study, and a follow-up analysis was done at 4 years. Both evaluations were based on the entire population of 646 patients.

What were the results of the study?

EMPLICITI in combination with REVLIMID and dexamethasone showed:

  • AT 4 YEARS, MORE PEOPLE TAKING EMPLICITI WERE LIVING WITH THEIR DISEASE UNDER CONTROL
    • At 2 years, there was a 41% chance that people taking EMPLICITI with REVLIMID and dexamethasone were living with their disease under control, compared with a 27% chance for people taking REVLIMID and dexamethasone alone.
    • At the 4-year follow-up, there was a 21% chance that people taking EMPLICITI with REVLIMID and dexamethasone were still living with their disease under control, compared with a 14% chance for people taking REVLIMID and dexamethasone alone.
  • 30% LESS RISK OF DISEASE PROGRESSION
    • After at least 2 years of follow-up, people who received EMPLICITI with REVLIMID and dexamethasone were at 30% less risk of their disease progressing or passing away from any cause, compared with people taking REVLIMID and dexamethasone alone. After at least 4 years of follow-up, results were similar.
  • ~4 OUT OF 5 PEOPLE RESPONDED TO TREATMENT
    • About 4 out of 5 people (78.5%) responded to treatment with EMPLICITI with REVLIMID and dexamethasone compared to about 2 out of 3 people (65.5%) taking REVLIMID and dexamethasone alone.

Selected Important Facts About EMPLICITI

What are the most common side effects?

  • 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
  • pneumonia

These are not all of the possible side effects of EMPLICITI.

Call your doctor for medical advice about side effects.

You can report any side effects you experience to the FDA by calling 1-800-FDA-1088.

Please read other Important Facts below.

Every patient has a story to share.

Click below to learn more about Angela’s story.

When her grandkids are around, Angela feeds off their energy and excitement. They love having fun whenever they visit her. At home, Angela has a garden and a green thumb. She enjoys getting her hands dirty because gardening is what helps her relax.
The story behind the selfie
Call 1-844-EMPLICITI (1-844-367-5424)
am to 8 pm ET Monday through Friday

Or call your doctor
Get Started on EMPLICITI

  • Dexamethasone:

    A steroid used in the treatment of multiple myeloma, often in combination with other medications. To learn more about dexamethasone, ask your healthcare team.

  • Immunotherapy:

    A type of treatment that works with your immune system to help control certain cancers. It is different because it is not surgery, radiation, or traditional chemotherapy.

  • Intravenous (IV) infusion:

    When medicine is given directly into the bloodstream through a vein—usually in the arm, hand, or through an IV port.

  • M protein:

    A type of protein made by myeloma cells. M protein levels may be used to estimate the extent of myeloma disease, and measuring them is one way to evaluate response to myeloma treatments.

  • Natural Killer (NK) Cell:

    A type of white blood cell that helps fight infection or disease and can be important for destroying cancerous cells.

  • Overall response rate:

    The percentage of patients who responded to treatment—for example, patients whose level of M protein was lowered by a certain amount. Overall response rates include complete response, very good partial response, and partial response.

  • Progression-free survival:

    The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

  • REVLIMID®

     (also known as lenalidomide):

    An oral medication with anti-myeloma effects. It is used in combination with other medications. To learn more about REVLIMID, ask your healthcare team.

Important Facts About EMPLICITI™ (elotuzumab)OTHER IMPORTANT FACTS

EMPLICITI in combination with REVLIMID® (lenalidomide) 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 associated with REVLIMID to females and males of reproductive potential, including possible serious birth defects or death of an unborn baby, and specific requirements regarding birth control, pregnancy testing and blood and/or sperm donation. For more information, please read the Important Facts throughout this website or by expanding this section. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI.

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

Keep this information in a safe place, so you can refer to it before and during your treatment. Look out for these icons as you read:

Talk to your healthcare teamCall a healthcare provider right awayHelpful information to remember
What is EMPLICITI?

EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with other medications:

EMPLICITI
(elotuzumab)
  REVLIMID®
(lenalidomide)
  dexamethasone

Remember to read the safety information for the other medications you are receiving.

EMPLICITI is for patients who have received one to three prior treatments for their multiple myeloma.

EMPLICITI is for adults. The safety and effectiveness of EMPLICITI has not been studied in children.

What are the possible side effects of EMPLICITI?

EMPLICITI may cause side effects, some of which can be serious. Your healthcare team will work with you to manage any side effects you may experience throughout your treatment with EMPLICITI.

Serious side effects

Infusion reactions can happen during your EMPLICITI infusion or within 24 hours after your infusion.
Symptoms of an infusion reaction may include:

  • fever
  • chills
  • rash
  • trouble breathing
  • dizziness
  • light-headedness

Before every EMPLICITI infusion, your healthcare team will give you medications to help reduce the risk of infusion reactions.
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.

Call your healthcare provider or get medical help right away if you have any of the above symptoms after your infusion with EMPLICITI.

Infections may develop in patients who receive EMPLICITI with REVLIMID and dexamethasone, and can be serious. Symptoms of an infection may include:

  • fever
  • flu-like symptoms
  • cough
  • shortness of breath
  • burning with urination
  • painful skin rash

Call a healthcare provider right away if you have any of the signs and symptoms of an infection.

Developing new cancers (malignancies) is a risk in patients who receive EMPLICITI with REVLIMID and dexamethasone. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI.

Talk to your healthcare team to learn more about your risk of developing new cancers if you receive EMPLICITI with REVLIMID and dexamethasone.

Liver problems may occur in patients who receive EMPLICITI. Symptoms of liver problems include:

  • tiredness
  • weakness
  • loss of appetite
  • yellowing of your skin or eyes
  • color changes in your stools
  •  
  • confusion
  • swelling of the stomach area

Your healthcare provider will do blood tests to check your liver function during your treatment with EMPLICITI.

Talk to your healthcare team if you have any of the signs and symptoms of liver problems.

The most common side effects

  • 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
  • pneumonia

These are not all of the possible side effects of EMPLICITI.

Call your doctor for medical advice about side effects.

You can report any side effects you experience to the FDA by calling 1-800-FDA-1088.

What should I discuss with my healthcare team before starting EMPLICITI?

Talk to your healthcare team about all of your medical conditions, including if you have an infection.

Let your healthcare team know as soon as possible if you are a woman who is pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if EMPLICITI can harm an unborn baby. However, REVLIMID®  may cause birth defects or death of an unborn baby. It is not known if EMPLICITI passes into breastmilk. You should not breastfeed during treatment with EMPLICITI with REVLIMID and dexamethasone.

Before receiving EMPLICITI with REVLIMID and dexamethasone females and males must agree to the instructions in the REVLIMID REMS® program. The REVLIMID REMS program has specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know.

Talk to your healthcare team to learn more about REVLIMID.

Interactions with other drugs may affect the way EMPLICITI works in your body.

Talk to your healthcare team about all of the medicines you are taking before starting EMPLICITI, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

Please read Patient Information in the Full Prescribing Information.

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