Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 8/11/17

Vogelxo (testosterone) Gel REMS

Goal of the Vogelxo (testosterone) Gel REMS Program

The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel.

REMS Elements

• Medication Guide

REMS Summary of Terms