Empliciti - Consumer Medicine Information
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||elotuzumab, citric acid monohydrate, polysorbate 80, sodium citrate, sucrose|
What is EMPLICITI
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.
It is not known if EMPLICITI is safe and effective in children.
Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection
- are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby.
- 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 provider to learn more about REVLIMID.
- are breastfeeding or plan to breastfeed. It is not known if EMPLICITI passes into breast milk. You should not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive EMPLICITI
- EMPLICITI will be given to you by intravenous (IV) infusion into your vein.
- Your EMPLICITI treatment schedule is divided into cycles that are 28 days (4 weeks) long. A cycle includes the number of days you are on treatment and also the time you spend resting in between treatments.
- EMPLICITI with REVLIMID and dexamethasone is usually given as follows:
- Cycles 1 and 2 (28 days per cycle), you will receive EMPLICITI one time every week.
- Cycles 3 and up (28 days per cycle), you will receive EMPLICITI one time every 2 weeks.
- Your healthcare provider will decide how many treatments you will receive.
- Before every EMPLICITI infusion, you will receive medicines to help reduce the risk of infusion reactions.
- If you miss any appointments call your healthcare provider as soon as possible.
What are the possible side effects of EMPLICITI
EMPLICITI may cause serious side effects, including:
- Infusion reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of 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 stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI:
- trouble breathing
- Infections. People with multiple myeloma who receive EMPLICITI with REVLIMID and dexamethasone may develop infections that can be serious. Tell your healthcare provider right away if you have any signs and symptoms of an infection, including:
- flu-like symptoms
- shortness of breath
- burning with urination
- a painful skin rash
- Risk of new cancers (malignancies). People with multiple myeloma who receive EMPLICITI with REVLIMID and dexamethasone have a risk of developing new cancers. Talk with your healthcare provider about your risk of developing new cancers if you receive EMPLICITI. Your healthcare provider will check you for new cancers during your treatment with EMPLICITI.
- Liver problems. EMPLICITI may cause liver problems. Your healthcare provider will do blood tests to check your liver during treatment with EMPLICITI. Tell your healthcare provider if you have signs and symptoms of liver problems, including: tiredness, weakness, loss of appetite, yellowing of your skin or eyes, color changes in your stools, confusion, or swelling of the stomach area.
The most common side effects of EMPLICITI include:
- numbness, weakness, tingling, or burning pain in your arms or legs
- sore throat or runny nose
- upper respiratory tract infection
- decreased appetite
These are not all of the possible side effects of EMPLICITI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Bristol-Myers Squibb at 1-800-721-5072.
General information about the safe and effective use of EMPLICITI
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
You can ask your pharmacist or healthcare provider for information about EMPLICITI that is written for health professionals.
What are the ingredients of EMPLICITI
citric acid monohydrate, polysorbate 80, sodium citrate, sucrose
For more information, call 1-844-EMPLICITI (844-367-5424) or visit EMPLICITI.com.