REVLIMID ® ( lenalidomide ) is indicated as maintenance therapy in patients with multiple myeloma ( 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 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 risk 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 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
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 or REVLIMID as maintenance therapy 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 the regimen should be 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