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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.

 

Stella H
Stella H.
What is EMPLICITI?
 

EMPLICITI (elotuzumab) is a first-of-its-kind immunotherapy medicine that directly activates a key type of white blood cell in your immune system—called a Natural Killer (NK) Cell—to fight multiple myeloma. EMPLICITI also identifies myeloma cells so they are more easily recognized by NK Cells. That way, activated NK Cells can find myeloma cells to destroy.

cells to fight multiple myeloma

EMPLICITI 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. EMPLICITI is for adults. The safety and effectiveness of EMPLICITI has not been studied in children. Talk to your healthcare provider to learn more.

To learn more about how EMPLICITI works, click here.

image shows a man who is an EMPLICITI patient taking a selfie. EMPLICITI 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.
Marcus L. 

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 of EMPLICITI?
  • 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.

Call 1-844-EMPLICITI (1-844-367-5424)
am to 8 pm ET Monday through Friday

Or call your doctor
Get Started on EMPLICITI

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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