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
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
Please see Important Safety Information and Brief Summary,
including Boxed WARNINGS, on the following pages.