ASH Clinical News ACN_3.13_FULL_ISSUE_DIGITAL | Page 38

REVLIMID ® (lenalidomide) is indicated as maintenance therapy in patients with multiple myeloma (MM) following autologous hematopoietic stem cell transplantation (auto-HSCT) REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials REVLIMID is only available through a restricted distribution program, REVLIMID REMS ® Most Patients With MM Achieve a Response Following Auto-HSCT— What Comes Next? REVLIMID maintenance therapy can help your patients maintain their response Lenalidomide (REVLIMID) is the only FDA-approved and only National Comprehensive Cancer Network ® (NCCN ® ) Category 1 recommended therapy for post auto-HSCT maintenance in patients with multiple myeloma 3,4 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. HEMATOLOGIC TOXICITY. REVLIMID can cause signifi cant neutropenia and thrombocytopenia. • For patients with del 5q myelodysplastic syndromes, monitor complete blood counts weekly for the fi rst 8 weeks and monthly thereafter. VENOUS AND ARTERIAL THROMBOEMBOLISM • Signifi cantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving REVLIMID with dexamethasone. Anti-thrombotic prophylaxis is recommended. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Please see Important Safety Information and Brief Summary, including Boxed WARNINGS, on the following pages.