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. 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:
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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:
People who have received at least 2 prior treatments, including Revlimid and a proteasome inhibitor, may receive:
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:
- chest pain
- trouble breathing
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:
- flu-like symptoms
- 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:
- loss of appetite
- yellowing of your skin or eyes
- color changes in your stools
- 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:
- numbness, weakness, tingling, or burning pain in your arms or legs
- sore throat or runny nose
- upper respiratory tract infection
- decreased appetite
The most common side effects of EMPLICITI when used with Pomalyst + dexamethasone include:
- 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
- herbal supplements
Please read the Patient Information in the Full Prescribing Information.