REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the
treatment of patients with multiple myeloma (MM). REVLIMID is not indicated and is not
recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside
of controlled clinical trials
NOW FOR NEWLY DIAGNOSED MULTIPLE MYELOMA
SHAPE
PROGRESSION-FREE
SURVIVAL WITH
CONTINUOUS TREATMENT
Continuous REVLIMID + dex until progression
showed a PFS and OS benefit in patients with
newly diagnosed multiple myeloma vs MPT
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.
VENOUS AND ARTERIAL THROMBOEMBOLISM
• Significantly 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.
REVLIMID is only available through a restricted distribution program, REVLIMID REMS®.
Please see additional Important Safety Information and Brief Summary, including Boxed WARNINGS, on the
following pages.
Learn more at www.REVLIMID.com