NOW APPROVED:
EMPLICITI® (elotuzumab) +
Pomalyst® (pomalidomide) + dexamethasone
EMPLICITI is now approved to treat multiple myeloma in combination with the medicines Pomalyst and dexamethasone in adults who have received at least two prior treatments including Revlimid® (lenalidomide) and a proteasome inhibitor.
EPd CLINICAL STUDY
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 THE 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 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.
-
TWICE AS MANY PATIENTS RESPONDED TO TREATMENT
- 53.3% of patients responded to treatment with EPd compared to 26.3% of patients taking Pd alone.
What are the possible side effects of EMPLICITI?
The most common side effects
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.
You can report any side effects you experience to the FDA by calling
1-800-FDA-1088.
Please read more Important Facts About EMPLICITI below.
POSSIBLE SIDE EFFECTS
KNOW THE SIDE EFFECTS THAT MAY OCCUR
What are the most common side effects?
EMPLICITI in combination with Pomalyst and dexamethasone (EPd) compared with Pomalyst and dexamethasone (Pd) alone.
| Most common side effects* | Patients taking EPd (60 patients) |
Patients taking Pd alone (55 patients) |
|---|---|---|
| constipation | 22% | 11% |
| high blood sugar | 20% | 15% |
| pneumonia | 18% | 13% |
| diarrhea | 18% | 9% |
| respiratory tract infection | 17% | 9% |
| bone pain | 15% | 9% |
| difficulty breathing, shortness of breath | 15% | 7% |
| muscle spasms | 13% | 5% |
| swelling in the hands or lower legs | 13% | 7% |
| low lymphocyte count | 10% | 1.8% |
These side effect rates were determined after the typical patient had received about 9 cycles of EPd or 5 cycles of Pd alone.
*At least 10% of patients receiving EPd experienced the side effects listed in the table above. Patients experienced those side effects at a 5% or greater rate than patients who took Pd alone.
These are not all the possible side effects of EMPLICITI. If you have questions, ask your healthcare provider and read more Important Facts about EMPLICITI below and the Patient Information in the Full Prescribing Information.
YOU MAY HAVE
TREATMENT-RELATED CHANGES TO YOUR BLOOD LEVELS
What are the possible changes?
EMPLICITI in combination with Pomalyst and dexamethasone (EPd) compared with Pomalyst and dexamethasone (Pd) alone.
| Blood-level changes† | Patients taking EPd (60 patients) |
Patients taking Pd alone (55 patients) |
|---|---|---|
| low number of lymphocytes | 98% | 91% |
| low number of white cells | 80% | 87% |
| low number of platelets | 78% | 73% |
| low level of albumin | 65% | 56% |
| low level of calcium | 58% | 40% |
| high level of glucose | 40% | 25% |
| low level of sodium | 40% | 18% |
| low level of potassium | 23% | 16% |
These changes were determined after the typical patient had received about 9 cycles of EPd or 5 cycles of Pd alone.
†At least 10% of patients receiving EPd experienced the side effects listed in the table above. Patients experienced those side effects at a 5% greater rate than patients who took Pd alone.
HOW EMPLICITI WORKS
You and EMPLICITI: FIGHTING MULTIPLE MYELOMA CELLS TOGETHER
Unlike traditional chemotherapy treatments, EMPLICITI is a first-of-its-kind immunotherapy medicine that works with your own immune system to fight multiple myeloma. EMPLICITI works in 2 ways. It activates a key type of white blood cell in your immune system, called a Natural Killer (NK) Cell. 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.
Multiple myeloma cell
NK Cell
EMPLICITI
EMPLICITI CAN HELP YOUR IMMUNE SYSTEM DESTROY MYELOMA CELLS
IDENTIFY
EMPLICITI identifies myeloma cells so they are easier to find
ACTIVATE
EMPLICITI activates NK Cells
DESTROY
Activated NK Cells find myeloma cells to destroy
Important Facts About EMPLICITI® (elotuzumab) OTHER IMPORTANT FACTS
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:
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:
(elotuzumab) Revlimid®
(lenalidomide) dexamethasone
People who have received at least 2 prior treatments, including Revlimid and a proteasome inhibitor, may receive:
(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.
© 2018 Bristol-Myers Squibb Company. All rights reserved.
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