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, for oral use
Initial U.S. Approval: 2005 

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 (5.1).

REVLIMID is available only through a restricted distribution program called the REVLIMID REMS® program (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).

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 (5.4).

RECENT MAJOR CHANGES

Indication and Usage (1.1) 02/17
Dosage and Administration (2.1, 2.4) 02/17
Warnings and Precautions (5.3, 5.4, 5.6, 5.12) 02/17

INDICATIONS AND USAGE

REVLIMID is a thalidomide analogue indicated for the treatment of patients with:
Multiple myeloma (MM), in combination with dexamethasone (1.1).
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1).
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).
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3).

Limitations of Use:
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (1.4).

DOSAGE AND ADMINISTRATION

MM combination therapy: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. Refer to section 14.1 for dexamethasone dosing (2.1, 14.1).
MM maintenance therapy following auto-HSCT: 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles (2.1).
MDS: 10 mg once daily (2.2).
MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles (2.3).
Continue or modify dosing based on clinical and laboratory findings (2.1, 2.2, 2.3).
Renal impairment: Adjust starting dose based on the creatinine clearance value (2.4).

DOSAGE FORMS AND STRENGTHS

Capsules: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg (3).

CONTRAINDICATIONS

Pregnancy (Boxed Warning, 4.1, 5.1, 8.1).
Demonstrated hypersensitivity to lenalidomide (4.2, 5.8).

WARNINGS AND PRECAUTIONS

Increased mortality: serious and fatal cardiac adverse reactio