Bosentan REMS Overview A Risk Evaluation and Mitigation Strategy (REMS) is used to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug outweigh its risks The Bosentan REMS is a ...
Bosentan REMS Overview A Risk Evaluation and Mitigation Strategy (REMS) is used to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug outweigh its risks The Bosentan REMS is a ...
(REMS) regarding the hazards to fetuses and the risks of causing liver damage. Before prescribing the medicine, the doctor must document a negative pregnancy test for women, instruct them on contraception, and provide them with it because bosentan is likely to induce liver damage. Pretesting for...
Because of the risks of hepatotoxicity and birth defects, TRACLEER is available only through a restricted program called the Bosentan REMS Program. As a component of the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program [seeBOX WARNING,Hepatotoxicity, Embryo-Fetal Toxic...
As a component of the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program [see Boxed Warning, Warnings and Precautions (5.1, 5.2), Contraindications (4.1)]. Required components of the Bosentan REMS are: Healthcare professionals who prescribe bosentan must review the ...