Risk Evaluation and Mitigation Strategies (REMS) Summary

Goals of the Letairis (ambrisentan) Tablets REMS Program

The goals of the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program are:

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

2. To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Letairis

    a. Females who are pregnant must not be prescribed Letairis

    b. Females taking Letairis must not become pregnant.

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms