Approved Risk Evaluation and Mitigation Strategies (REMS)

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Fortesta (testosterone)
NDA #021463
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 Fortesta REMS, see the DailyMed link(s).
Material Name Material Name Link
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fortesta_2015.05.11_REMS_document.pdf

What updates have been made to the REMS?

Date Summary of change
05/11/2015 Modified to add the risk of major adverse cardiovascular events associated with testosterone replacement therapy to the Medication Guide.
07/31/2014 Modified to include the authorized generic in the REMS.
06/19/2014 Modified to add the risk of venous thromboembolic events associated with testosterone use to the Medication Guide.
03/24/2014 Modified to add a new application site diagram in the Medication Guide.
09/11/2013 Modified to

  1. Improve communication about the risk of secondary exposure in women and children in the Medicaiton Guide.
  2. Include the date of initial approval and most recent modification in the REMS document
12/29/2010 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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