These highlights do not include all the information needed to use REVLIMID safely and effectively. See full prescribing information for REVLIMID.
REVLIMID (lenalidomide) capsules
Initial U.S. Approval: 2005
WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM See full prescribing information for complete boxed warning
Fetal Risk
Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby.
Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception (5.2).
REVLIMID is available only under a restricted distribution program called “RevAssist.” (5.2, 17).
Hematologic Toxicity
REVLIMID can cause significant neutropenia and thrombocytopenia (5.3).
For patients with del 5q myelodysplastic syndromes, monitor complete blood counts weekly for the first 8 weeks and monthly thereafter (5.3).
Deep Vein Thrombosis and Pulmonary Embolism
Significantly increased risk of DVT and PE in patients with multiple myeloma receiving REVLIMID with dexamethasone (5.4).
