Black Box Warning

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY Lenalidomide can cause significant birth defects or death of the unborn baby if taken during pregnancy. Women must not become pregnant while taking lenalidomide. Lenalidomide can cause serious and life-threatening neutropenia and thrombocytopenia. Monitor blood counts regularly. Thromboembolic Events: Deep vein thrombosis (DVT) and pulmonary embolism (PE) have occurred in patients receiving lenalidomide. Patients should be advised to seek medical attention if they experience symptoms, such as shortness of breath or chest pain. Tumor Lysis Syndrome (TLS): TLS has been reported with lenalidomide and appropriate precautions should be considered. Second Primary Malignancies: Cases of second primary malignancies, including hematologic malignancies and solid tumors, have been reported. Hepatotoxicity: Cases of severe, sometimes fatal, hepatotoxicity have been reported with lenalidomide. Monitor patients for signs and symptoms of hepatic dysfunction.