Indications
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
Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb
abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes
severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause
birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy
tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of
contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID
treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a
restricted distribution program, the REVLIMID REMS ® program.
Information about the REVLIMID REMS ® program is available at www.celgeneriskmanagement.com or
by calling the manufacturer’s toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can cause signifi cant neutropenia and thrombocytopenia. Eighty percent of patients with del
5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had
to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients
enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts
monitored weekly for the fi rst 8 weeks of therapy and at least monthly thereafter. Patients may require
dose interruption and/or reduction. Patients may require use of blood product support and/or growth
factors.
Venous and Arterial Thromboembolism
REVLIMID has demonstrated a 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 MM who
were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs
and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop
symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is
recommended and the choice of regimen should be based on an assessment of the patient’s
underlying risks.
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
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS
• Females of Reproductive Potential: See Boxed WARNINGS
• Males: Lenalidomide is present in the semen of patients receiving the drug. Males must always use a
latex or synthetic condom during any sexual contact with females of reproductive potential while taking
REVLIMID and for up to 4 weeks after discontinuing REVLIMID, even if they have undergone a successful
vasectomy. Male patients taking REVLIMID must not donate sperm
• Blood Donation: Patients must not donate blood during treatment with REVLIMID and for 4 weeks
following discontinuation of the drug because the blood might be given to a pregnant female patient
whose fetus must not be exposed to REVLIMID
Please see Important Safety Information and Brief Summary,
including Boxed WARNINGS, on the following pages.