Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 5/11/15

AndroGel (testosterone gel) 1.62% REMS

Goal of the AndroGel (testosterone gel) 1.62% REMS Program

To inform patients about the serious risks associated with the use of AndroGel (testosterone gel) 1.62%.

REMS Elements

• Medication Guide

Open the Full REMS Notification

REMS Summary of Terms