Approved Risk Evaluation and Mitigation Strategies (REMS)

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Testim (testosterone)
NDA #021454
REMS last update: 05/11/2015

What is the purpose of the REMS?

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

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s).

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Testim REMS, see the DailyMed link(s).
Material Name Material Name Link
REMS document (PDF)

What updates have been made to the REMS?

Date Summary of change
05/11/2015 Modified to include the risk of major adverse cardiovascular events associated with testosterone replacement therapy in the Medication Guide.
06/19/2014 Modified to include the risk of venous thromboembolic events associated with testosterone use in the Medication Guide.
05/01/2014 Modified to add an authorized generic to the REMS.
08/30/2013 Modified to account for the new applicant name, address, and contact information in the Medication Guide.
11/22/2011 Modified to add information about the risk of secondary exposure in children in the Medicaiton Guide.
09/18/2009 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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