re life-threatening birth defects. REVLIMID has not been tested in pregnant women. REVLIMID has harmed unborn animals in animal testing.
Females must not get pregnant:
for 4 weeks before starting REVLIMID
while taking REVLIMID
during any breaks (interruptions) in your treatment with REVLIMID
for 4 weeks after stopping REVLIMID
If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call 1-888-668-2528 for medical information. Healthcare providers and patients should report all cases of pregnancy to:
FDA MedWatch at 1-800-FDA-1088, and
Celgene Corporation at 1-888-423-5436
It is not known if REVLIMID passes into semen, so:
Males, including those who have had a vasectomy, must use a latex condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID. (If you or your partner are allergic to latex, please consult with your healthcare provider)
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.
Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.
Men, if your female partner becomes pregnant, you should call your healthcare provider right away.
Low white blood cells (neutropenia) and low platelets (thrombocytopenia).
REVLIMID causes low white blood cells and low platelets in most patients. You may need a blood transfusion or certain medicines if your blood counts drop too low. If you are being treated for del 5q myelodysplastic syndromes (MDS) your blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID, and at least monthly thereafter. If you are being treated for multiple myeloma, your blood counts should be checked every 2 weeks for the first 12 weeks and then at least monthly thereafter.
A higher chance for blood clots in your veins and lungs. Call your healthcare provider or get medical help right away if you get any of these signs or symptoms:
shortness of breath
chest pain
arm or leg swelling
What is REVLIMID?
REVLIMID is a prescription medicine taken by mouth to treat certain patients who have myelodysplastic syndromes (MDS). People with MDS have bone marrow that does not produce enough mature blood cells. This causes a lack of healthy blood cells that can function properly in the body. There are different types of MDS. REVLIMID is for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.
REVLIMID is also used with dexamethasone to treat people with multiple myeloma who have already had another treatment. Multiple myeloma is a cancer of plasma cells. Plasma cells are found in the bone marrow. Normal plasma cells produce proteins called antibodies. Some antibodies can attack and kill disease causing germs. People with multiple myeloma may have low blood cell counts and immune problems giving them a higher chanc |
