Contact your
Local MSL
Request A Medical Science
Liaison (MSL)
Contact your
Local MSL
Request A Medical Science
Liaison (MSL)

Macitentan 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 REMS and comply with its requirements for prescribing OPSUMIT®.

  • All female patients must be enrolled in Macitentan REMS in order to receive OPSUMIT®
  • Male patients are not required to enroll in Macitentan REMS

Goals of Macitentan REMS

Macitentan REMS is designed to:

  • Inform prescribers, patients, and pharmacists about the risk of serious birth defects and safe-use conditions for OPSUMIT®
  • Minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential who are prescribed OPSUMIT®
    • Females who are pregnant must not be prescribed OPSUMIT®
    • Females taking OPSUMIT® must not become pregnant

The Macitentan REMS web page includes full information about prescriber responsibilities, patient information, pharmacy certification, and enrollment.

Review the
REPAIR study


SERAPHIN PAH-related hospitalization results

View the Data

View SERAPHIN PAH-CTD subgroup data

See the Data



+ +