HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use REVLIMID safely and effectively. See full prescribing information for REVLIMID.
REVLIMID (lenalidomide) capsules
Initial U.S. Approval: 2005
WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
See full prescribing information for complete boxed warning
Fetal Risk
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 death to a developing baby.
Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception (5.2).
REVLIMID is available only under a restricted distribution program called “RevAssist.” (5.2, 17).
Hematologic Toxicity
REVLIMID can cause significant neutropenia and thrombocytopenia (5.3).
For patients with del 5q myelodysplastic syndromes, monitor complete blood counts weekly for the first 8 weeks and monthly thereafter (5.3).
Deep Vein Thrombosis and Pulmonary Embolism
Significantly increased risk of DVT and PE in patients with multiple myeloma receiving REVLIMID with dexamethasone (5.4).
RECENT MAJOR CHANGES
Boxed Warning 03/10
Indications and Usage (1.1, 1.2) 03/10
Dosage and Administration (2.1, 2.2) 03/10
Contraindications (4.1, 4.2) 03/10
Warnings and Precautions (5) 03/10
Patients with Renal Impairment (8.6) 03/10
INDICATIONS AND USAGE
REVLIMID is a thalidomide analogue indicated for the treatment of:
Multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy (1.1).
Patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2).
DOSAGE AND ADMINISTRATION
MM: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. Recommended dose of dexamethasone is 40 mg once daily on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg/day orally on Days 1-4 every 28 days (2.1).
MDS: 10 mg once daily (2.2).
Continue or modify dosing based on clinical and laboratory findings (2.1, 2.2).
Renal impairment: Adjust starting dose in patients with moderate or severe renal impairment (CLcr<60 mL/min) (2.1, 2.2).
DOSAGE FORMS AND STRENGTHS
Capsules: 5 mg, 10 mg, 15 mg and 25 mg (3).

CONTRAINDICATIONS
Pregnancy (Boxed Warnings, 4.1, 5.1, 8.1).
Demonstrated hypersensitivity to lenalidomide (4.2, 5.5).
WARNINGS AND PRECAUTIONS
Females of childbearing potential: Must have 2 negative pregnancy tests before starting treatment with REVLIMID and must use two forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after treatment. Reproductive Risk and Special Prescribing Requirements: To avoid fetal exposure REVLIMID is only available under a special restricted distribution program called RevAssist (Boxed Warnings, 4.1, 5.1, 17).
Hematologic Toxicity: This drug is associated with significant neutropenia and thrombocytopenia. Patients may require dose interruption and/or dose reduction (5.3, 6.1).
Deep vein thrombosis and pu