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 OPSUMIT®.

All female patients must be enrolled in Macitentan-Containing Products REMS in order to receive OPSUMIT®
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 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-Containing Products REMS web page includes full information about prescriber responsibilities, patient information, pharmacy certification, and enrollment.

Learn About Macitentan-Containing Products REMS

Download Patient
REMS Form

Dosing and Administration

LEARN MORE

Downloadable resources

To report suspected adverse reactions, contact Johnson & Johnson at 1-800-526-7736, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contact Medical Information

EXPAND +

+ +