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Return to previous pageMACITENTAN-CONTAINING PRODUCTS REMS
Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS)
A REMS program is required by the US Food and Drug Administration (FDA) to manage serious risks associated with a drug product. All healthcare providers must enroll in Macitentan-Containing Products REMS and comply with its requirements for prescribing OPSYNVI® (macitentan/tadalafil).
- All female patients must be enrolled in Macitentan-Containing Products REMS in order to receive OPSYNVI®
- Male patients are not required to enroll in Macitentan-Containing Products REMS
Goals of Macitentan-Containing Products REMS
Macitentan-Containing Products REMS is designed to:
- Inform prescribers, patients, and pharmacists about the risk of serious birth defects and safe-use conditions for OPSYNVI®
- Minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential who are prescribed OPSYNVI®
- Females who are pregnant must not be prescribed OPSYNVI®
- Females taking OPSYNVI® must not become pregnant
The Macitentan-Containing Products REMS web page includes full information about prescriber responsibilities, patient information, pharmacy certification, and enrollment.
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