REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled
clinical trials
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 (formerly known as the “RevAssist®” 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 significant 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 first 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 significantly 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 hazard to the fetus
Allergic Reactions: REVLIMID is contraindicated in patients who have
demonstrated 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 28 days 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 1 month following discontinuation of the drug because
the blood might be given to a pregnant female patient whose fetus must
not be exposed to REVLIMID
REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers and
pharmacies must be certified with the REVLIMID REMS program by enrolling
and complying with the REMS requirements; pharmacies must only dispense
to patients who are authorized to receive REVLIMID. Patients must sign a
Patient-Physician Agreement Form and comply with REMS requirements; female
patients of reproductive potential who are not pregnant must comply with the
pregnancy testing and contraception requirements and males must comply with
contraception requirements
Hematologic Toxicity: REVLIMID can cause significant neutropenia and
thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise
patients to observe for bleeding or bruising, especially with use of concomitant
medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex
should have their complete blood counts (CBC) assessed every 7 days for the first
2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter
Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous
thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are
increased in patients treated with REVLIMID. Patients with known risk factors,
including prior thrombosis, may be at greater risk and actions should be taken
to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension,
smoking). Thromboprophylaxis is recommended and regimen is based on
patients underlying risks. ESAs and estrogens may further increase the risk of
thrombosis and their use should be based on a benefit-risk decision
Increased Mortality in Patients With CLL: In a clinical trial in the first
line treatment of patients with CLL, single agent REVLIMID therapy increased
the risk of death as compared to single agent chlorambucil. Serious adverse
cardiovascular reactions, including atrial fibrillation, myocardial infarction, and
cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not
indicated and not recommended for use in CLL outside of controlled clinical trials
Second Primary Malignancies (SPM): In clinical trials in patients with
MM receiving REVLIMID, an increase of invasive SPM notably AML and MDS
have been observed. Monitor patients for the development of SPMs. Take into
account both the potential benefit of REVLIMID and risk of SPMs when
considering treatment
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients
treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline
liver enzymes, and concomitant medications may be risk factors. Monitor liver
enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After
return to baseline values, treatment at a lower dose may be considered