Risk Evaluation and Mitigation Strategies (REMS) Summary

Goals of the Opsumit (macitentan) Tablets REMS Program

The goals of the REMS are:

1. To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Opsumit

2. To minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential (FRP) prescribed Opsumit:

    a) Females who are pregnant must not be prescribed Opsumit

    b) Females taking Opsumit must not become pregnant

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms