ASH Clinical News December 2014 | Page 30

REVLIMID is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib REVLIMID is not indicated and not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials VISIT ASH BOOTH #805 TO LEARN MORE ABOUT REVLIMID TOGETHER WE STRIVE TO SHAPE EXPECTATIONS for patients with relapsed or refractory mantle cell lymphoma Print-only content WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY • 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 embryo-fetal death. • Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception. REVLIMID is available only through a restricted distribution program called the REVLIMID REMS® program (formerly known as the “RevAssist® program”). HEMATOLOGIC TOXICITY. REVLIMID can cause significant neutropenia and thrombocytopenia. • For patients with del 5q myelodysplastic syndromes, monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. For more information, please visit www.REVLIMID.com or call 1-888-423-5436. VENOUS AND ARTERIAL THROMBOEMBOLISM REVLIMID is only available through a restricted distribution program, REVLIMID REMS®. • Please see Important Safety Information, including Boxed WARNINGS, and Brief Summary of full Prescribing Information on the following pages. Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as a risk of myocardial infarction, and stroke in patients with multiple myeloma receiving REVLIMID with dexamethasone. Anti-thrombotic prophylaxis is recommended.