Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 7/3/17

Qsymia (phentermine and topiramate) Extended-Release Capsules REMS

Goal of the Qsymia (phentermine and topiramate) Extended-Release Capsules REMS Program

To inform prescribers and females of reproductive potential about:

• the increased risk of congenital malformations, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy

• the importance of pregnancy prevention for females of reproductive potential receiving Qsymia

• the need to discontinue Qsymia immediately if pregnancy occurs.

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System