For U.S. Healthcare Professionals

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.

Learn About Macitentan REMS
Download Patient
REMS Form

Review the
REPAIR study

DISCOVER THE DATA

SERAPHIN PAH-related hospitalization results

View the Data

View SERAPHIN PAH-CTD subgroup data

See the Data

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To report suspected adverse reactions, contact Janssen at 1-800-JANSSEN (1-800-526-7736), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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