Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 1/17/17

Adempas (riociguat) Tablets REMS

Goals of the Adempas (riociguat) Tablets REMS Program

The goals of the Adempas REMS are:

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

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

a. Females who are pregnant must not be prescribed Adempas

b. Females taking Adempas must not become pregnant

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System