WARNINGS:
- 1. Potential for Human Birth Defects
- 2. Hematologic Toxicity (Neutropenia and Thrombocytopenia)
- 3. Deep Venous Thrombosis and Pulmonary Embolism
Potential for Human Birth Defects: Warning: Potential for Human Birth Defects
- Lenalidomide is an analogue of thalidomide. Thalidomide is a known human teratogen that causes severe life threatening human birth defects. If lenalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Females should be advised to avoid pregnancy while taking revlimid (lenalidomide).
Special Prescribing Requirements
- Because of this potential toxicity and to avoid fetal exposure to lenalidomide, this drug is only available under a special restricted distribution program, this program is called "RevAssist". Under this program, only prescribers and the pharmacists registered with the program can prescribe and dispense the product. In addition, lenalidomide must only be dispensed to patients who are registered and meet all the conditions of the RevAssist Program.
- Please Refer to Package Insert regarding information for Prescribers, Female Patients, and Male Patients about this Restricted Distribution Program (including requirements for negative pregnancy tests prior to initiation of therapy).
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
- This drug is associated with significant neutropenia and thrombocytopenia in patients with del 5q MDS. Eighty percent of patients 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. (See Dosage and Administration)
Deep Venous Thrombosis and Pulmonary Embolism
-
This drug has demonstrated a significantly increased risk of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma who were treated with Revlimid (lenalidomide) combination therapy. Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with lenalidomide may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patients underlying risk factors.Information about the RevAssist Program can be found at www.REVLIMID.com or at 1-888-423-5436.
Patient Counseling Information
Medication Guides
Package Inserts