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
REVLIMID is only available through a restricted distribution program, REVLIMID REMS®
FOR PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA WHO DID NOT RECEIVE AN
AUTOLOGOUS STEM CELL TRANSPLANT
EXTEND PROGRESSION-FREE
SURVIVAL WITH CONTINUOUS
TREATMENT
REVLIMID + dexamethasone until progression
or unacceptable toxicity
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.
SELECTED SAFETY INFORMATION: WARNINGS AND PRECAUTIONS
Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (> 4 cycles) with REVLIMID has
been reported. Consider early referral to transplant center to optimize timing of the stem cell collection
Please see additional Important Safety Information and brief summary of full Prescribing Information, including
Boxed WARNINGS, on the following pages.
Learn more at www.REVLIMID.com