START with REVLIMID
as a FOUNDATION
in newly diagnosed MM
Indications
REVLIMID ® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of
patients with multiple myeloma (MM)
REVLIMID is indicated as maintenance therapy in patients with 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 ®
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and
ARTERIAL THROMBOEMBOLISM
Please see the next spread and brief summary 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.
CONTRAINDICATIONS
Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is
contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient
becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus
Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated
severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to
lenalidomide
Please see Important Safety Information and Brief Summary,
including Boxed WARNINGS, on the following pages.