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The goals of the THALOMID risk evaluation and mitigation strategy are as follows: To prevent the risk of embryo-fetal exposure to THALOMID. To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.
To achieve its goal of the lowest possible incidence of drug-associated teratogenicity, the S.T.E.P.S. program uses a three-pronged approach: (1) controlling access to the drug; (2) educating prescribers, pharmacists, and patients; and (3) monitoring compliance.
12 cze 2023 · Further steps for addressing thalidomide toxicity involve enrolling both physician and patient into the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S) program.
To avoid embryo-fetal exposure, Risk Evaluation and Mitigation Strategy (REMS) programs are mandatory for the REMS products THALOMID ® (thalidomide), POMALYST ® (pomalidomide), REVLIMID ® (lenalidomide) and generic lenalidomide.
1 lut 1999 · To achieve its goal of the lowest possible incidence of drug-associated teratogenicity, the S.T.E.P.S. ™ program uses a three-pronged approach: (1) controlling access to the drug; (2) educating prescribers, pharmacists, and patients; and (3) monitoring compliance.
THALOMID to patients who are enrolled and meet all the conditions of the THALOMID REMS program • Information about THALOMID and the THALOMID REMS program can be obtained by calling the REMS Call Center toll-free at 1-888-423-5436 , or at www.ThalomidREMS.com
Dispensing pharmacies must be certified in the THALOMID REMS® program and must be educated in the following dispensing procedures. Step 1. Review incoming THALOMID® (thalidomide) prescriptions A. Only accept prescriptions with an authorization number and patient risk category written on them.