Embryo-Fetal Toxicity and Venous Thromboembolism
- If THALOMID® (thalidomide) is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. THALOMID® (thalidomide) should never be used by females who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects.
- Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to THALOMID® (thalidomide) as negligible as possible, THALOMID® (thalidomide) is approved for marketing only through a special restricted distribution program: THALOMID REMS® program, approved by the Food and Drug Administration. This program was formerly known as the “System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.® program)”.
- You can get the information about THALOMID and the THALOMID REMS program on the Internet at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-54361-888-423-5436 FREE.
- The use of THALOMID® (thalidomide) in multiple myeloma results in an increased risk of venous thromboembolism, such as deep venous thrombosis and pulmonary embolism. This risk increases significantly when thalidomide is used in combination with standard chemotherapeutic agents including dexamethasone. In one controlled trial, the rate of venous thromboembolism was 22.5% in patients receiving thalidomide in combination with dexamethasone compared to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Instruct patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Consider thromboprophylaxis based on an assessment of individual patients’ underlying risk factors.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Women of child bearing potential: Must use effective contraception (2 methods) > 4 wks prior to therapy, during therapy and 4 weeks post therapy. Have negative pregnancy test (with sensitivity > 50 mIU/mL) 24 hrs prior to initiation of therapy
- Male patients: latex condom required during sexual contact with women of child bearing potential
- See product insert for very specific instructions and informed consent guidelines for both male and female patients
FDA and Industry Communications
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information