What is REVLIMID® (lenalidomide)?
REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial. It is not known if REVLIMID is safe and effective in children.
Before you begin taking REVLIMID, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing REVLIMID, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form.
REVLIMID may cause serious side effects, including:
- Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.
REVLIMID is similar to the medicine thalidomide which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.
Females must not get pregnant:
- For at least 4 weeks before starting REVLIMID
- While taking REVLIMID
- During any breaks (interruptions) in your treatment with REVLIMID
- For at least 4 weeks after stopping REVLIMID
Females who can become pregnant:
- Must have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.
- If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
- Must agree to use 2 different forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.
- Talk with your healthcare provider to find out about options for effective forms of birth control that you may use to prevent pregnancy before, during, and after treatment with REVLIMID.
- If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away.
