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Call 1-844-EMPLICITI (1-844-367-5424)
BMS Access Support®

This site is intended for U.S. residents 18 years of age or older.

 

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 is safe and effective in children.

EMPLICITI Clinical STUDY Results

Angela B., EMPLICITI patient. Wade, Angela's caregiver. Angela takes EMPLICITI + Revlimid® (lenalidomide) + dexamethasone.

HELPING YOU UNDERSTAND THE POTENTIAL EFFECTS OF TREATMENT

To learn more about the clinical study results for EMPLICITI, choose a treatment combination below and expand the full results.

EMPLICITI was studied in combination with the medicines Pomalyst and dexamethasone, and was compared with Pomalyst and dexamethasone alone. Patients in the study had at least 2 prior treatments for multiple myeloma, including Revlimid and a proteasome inhibitor.

EPd vs. Pd alone.

SEE EPd RESULTS

EMPLICITI was studied in combination with the medicines Revlimid and dexamethasone, and was compared with Revlimid and dexamethasone alone. All patients in the study had received one to three prior multiple myeloma treatments.

ERd vs. Rd alone.

SEE ERd RESULTS

EMPLICITI was studied in combination with the medicines Pomalyst and dexamethasone (EPd), and was compared with Pomalyst and dexamethasone (Pd) alone.

How many patients were in the study?

There were 117 patients with relapsed or refractory multiple myeloma in the clinical study. 60 of the patients in the study received EPd. 57 of them received Pd alone.

Patients in the study had at least 2 prior treatments for multiple myeloma, including Revlimid and a proteasome inhibitor.

What were the goals of the study?

The study was designed to look at progression-free survival (PFS). PFS 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 overall response rate (ORR)—the percentage of patients who responded to treatment, for example, patients whose level of M protein was lowered by a certain amount. ORRs include stringent complete response, complete response, very good partial response, and partial response.

POWERFUL RESULTS FROM A PROVEN APPROACH

What were the results of the study?

EMPLICITI in combination with Pomalyst and dexamethasone (EPd) compared with Pomalyst and dexamethasone (Pd) alone showed:

 

46% LESS RISK OF DISEASE GETTING WORSE

After at least 9.1 months of follow-up, patients who received EPd were at 46% less risk of their disease progressing or of passing away from any cause, compared with patients taking Pd alone.

After at least 9.1 months of follow-up, patients who received EPd were at 46% less risk of their disease progressing or of passing away from any cause, compared with patients taking Pd alone.

PATIENTS TAKING EMPLICITI WERE LIVING LONGER WITH THEIR DISEASE UNDER CONTROL

Half of the patients taking EPd went 10.25 months without their multiple myeloma spreading, growing, or getting worse compared with 4.67 months for patients taking Pd alone.

Half of the patients taking EPd went 10.25 months without their multiple myeloma spreading, growing, or getting worse compared with 4.67 months for patients taking Pd alone.

TWICE AS MANY PATIENTS RESPONDED TO TREATMENT

53.3% of patients responded to treatment with EPd compared to 26.3% taking Pd alone.

53.3% of patients responded to treatment with EPd compared to 26.3% taking Pd alone.

Selected Important Facts About EMPLICITI

What are the possible side effects of EMPLICITI?

The most common side effects of EMPLICITI when used with Pomalyst + dexamethasone include:

  • constipation
  • high blood sugar

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 more Important Facts below, including other serious side effects.

Additional Study Results

EMPLICITI was also studied in combination with Revlimid and dexamethasone.

SEE THE RESULTS

EMPLICITI was studied in combination with the medicines Revlimid and dexamethasone (ERd), and was compared with Revlimid and dexamethasone (Rd) alone. All patients in the study had received one to three prior multiple myeloma treatments.

How many patients were in the study?

There were 646 patients with multiple myeloma in the clinical study. 321 of the patients in the study received ERd. 325 of them received Rd alone. All of them had already received 1 to 3 other treatments.

What were the goals 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 stringent complete response, 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 5 years. Both evaluations were based on the entire population of 646 patients.

RESULTS FROM A PROVEN APPROACH

What were the results of the study?

EMPLICITI in combination with Revlimid and dexamethasone (ERd) compared with Revlimid and dexamethasone (Rd) alone showed:

 

AT 5 YEARS, MORE PATIENTS TAKING EMPLICITI WERE LIVING WITH THEIR DISEASE UNDER CONTROL

At the time of the main analysis at 2 years, there was a 41% chance that patients taking ERd were living with their disease under control, compared with a 27% chance for patients taking Rd alone.

At the 5-year follow-up, there was an 18% chance that patients taking ERd were still living with their disease under control, compared with a 12% chance for patients taking Rd alone.

At the time of the main analysis at 2 years, there was a 41% chance that patients taking ERd were living with their disease under control, compared with a 27% chance for patients taking Rd alone.

At the 5-year follow-up, there was an 18% chance that patients taking ERd were still living with their disease under control, compared with a 12% chance for patients taking Rd alone.

30% LESS RISK OF DISEASE PROGRESSION

After at least 2 years of follow-up, patients who received ERd were at 30% less risk of their disease progressing or passing away from any cause, compared with patients taking Rd alone. After at least 5 years of follow-up, results were similar.

After at least 2 years of follow-up, patients who received ERd were at 30% less risk of their disease progressing or passing away from any cause, compared with patients taking Rd alone. After at least 5 years of follow-up, results were similar.

~4 OUT OF 5 PATIENTS RESPONDED TO TREATMENT

About 4 out of 5 patients (78.5%) responded to treatment with ERd compared to about 2 out of 3 patients (65.5%) taking Rd alone.

About 4 out of 5 patients (78.5%) responded to treatment with ERd compared to about 2 out of 3 patients (65.5%) taking Rd alone.

Selected Important Facts About EMPLICITI

What are the possible side effects of EMPLICITI?

The most common side effects of EMPLICITI when used with Revlimid + 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
  • 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 more Important Facts below, including other serious side effects.

Additional Study Results

EMPLICITI was also studied in combination with Pomalyst and dexamethasone.

SEE THE RESULTS

Ongoing Support and Resources

Whether you’re considering discussing EMPLICITI with your healthcare team or just beginning treatment, EMPLICITI with You is here to provide the free, comprehensive resources and support you or your loved one may need.

SIGN UP NOW

If you'd like to sign up for the EMPLICITI with You program or if you have general questions about EMPLICITI, call
1-844-EMPLICITI
(1-844-367-5424) 8 am to 8 pm ET, Monday to Friday, or click here to sign up.

I don’t know what I’d have done without my best friend Wade by my side.

VIEW ANGELA'S STORY

I don’t know what I’d have done without my best friend Wade by my side.

VIEW ANGELA'S STORY

VIEW MORE PATIENT STORIES

Angela B., EMPLICITI patient, and her family. Angela takes EMPLICITI + Revlimid® (lenalidomide) + dexamethasone.

EMPLICITI is given through an intravenous (IV) infusion.

Learn about infusion timing and dosing.

RECEIVING EMPLICITI

Important Facts About EMPLICITI® (elotuzumab)

EMPLICITI in combination with
Revlimid® (lenalidomide) and dexamethasone or in combination with Pomalyst® (pomalidomide) 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 and Pomalyst 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 with other medications to treat the following types of adult patients with multiple myeloma:

People who have received 1-3 prior treatments for their multiple myeloma may receive:

EMPLICITI
(elotuzumab)
  Revlimid®
(lenalidomide)
  dexamethasone

People who have received at least 2 prior treatments, including Revlimid and a proteasome inhibitor, may receive:

EMPLICITI
(elotuzumab)
  Pomalyst®
(pomalidomide)
  dexamethasone

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

The safety and effectiveness of EMPLICITI have 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
  • chest pain
  • trouble breathing

  • dizziness
  • light-headedness

Before every EMPLICITI infusion, your healthcare team will give you medications to help lower your chances of having 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 decide to stop all your EMPLICITI infusions.

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 occur in patients who receive EMPLICITI + Revlimid + dexamethasone or EMPLICITI + Pomalyst + 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 signs or symptoms of an infection.

Developing new cancers (malignancies) is a risk in patients who receive EMPLICITI with Revlimid + dexamethasone or EMPLICITI with Pomalyst + 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.

Liver problems may occur. 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 during your treatment with EMPLICITI.

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

The most common side effects

The most common side effects of EMPLICITI when used with Revlimid + 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
  • pneumonia

The most common side effects of EMPLICITI when used with Pomalyst + dexamethasone include:

  • constipation
  • high blood sugar

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 pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if EMPLICITI can harm an unborn baby. However, Revlimid and Pomalyst 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 + Revlimid + dexamethasone or with EMPLICITI + Pomalyst + dexamethasone.

Before receiving EMPLICITI + Revlimid + dexamethasone, or EMPLICITI + Pomalyst + dexamethasone, females and males must agree to the instructions in the Revlimid REMS® program or the Pomalyst REMS® program, depending on which combination was prescribed for you. The programs have 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 or Pomalyst.

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

Talk to your healthcare team about all the medicines you take, including:

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

Please read the Patient Information in the Full Prescribing Information.

689US1803829-03-01 04/19

  • 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 stringent complete response, complete response, very good partial response, and partial response.

  • Progression-free survival:

    The length of time during and after 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.

  • Pomalyst (also known as pomalidomide):

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