Lenalidomide Capsules 25mg

Description

Lenalidomide (5mg, 10mg , 25mg) 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). Lenalidomide 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 Lenalidomide is safe and effective in children.What is the most important information I should know about Lenalidomide ?Before you begin taking Lenalidomide , you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribingLenalidomide , your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form.Lenalidomide 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 takeLenalidomide .Lenalidomide is similar to the medicine thalidomide which is known to cause severe life-threatening birth defects. Lenalidomide has not been tested in pregnant females. Lenalidomide has harmed unborn animals in animal testing.Females must not get pregnant:For at least 4 weeks before startingLenalidomide While taking Lenalidomide During any breaks (interruptions) in your treatment with Lenalidomide For at least 4 weeks after stopping Lenalidomide 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 stoppingLenalidomide .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 withLenalidomide .If you had unprotected sex or if you think your birth control has failed, stop taking Lenalidomide immediately and call your healthcare provider right away.If you become pregnant while takingLenalidomide , stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to:FDA MedWatch at 1-800-FDA-1088, andCelgene Corporation, a Bristol Myers Squibb company, at 1-888-423-5436.There is a pregnancy exposure registry that monitors the outcomes of females who take Lenalidomide during pregnancy, or if their male partner takes Lenalidomide and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation, a Bristol Myers Squibb company, at the phone number listed above.Lenalidomide can pass into human semen:Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while takingLenalidomide , during any breaks (interruptions) in your treatment withLenalidomide , and for up to 4 weeks after stoppingLenalidomide .Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.