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Approved Risk Evaluation and Mitigation Strategies (REMS)

Axiron (testosterone)
NDA #022504
REMS last update: 07/13/2017



What is the purpose of the REMS?

To inform patients about the serious risks associated with the use of AXIRON® (testosterone) topical solution and its authorized generic.

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 Axiron REMS, see the DailyMed link(s).
Material Name Material Name Link
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Axiron_2017_07_13_REMS_document.pdf
Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
07/13/2017 Modified Medication Guide to reflect changes made from the information that was gained from the results of a Human Factors study and the addition of a Twist applicator.
02/03/2017 Modified to align the storage temperature listed in the Medication Guide to the storage conditions in other product labeling (i.e. USPI, container label, and carton) and add the statement “Store upright” in the Medication Guide.
01/23/2017 Modified to include an authorized generic in the REMS document and appended materials.
05/11/2015 Modified to:

  1. Add the risk of major adverse cardiovascular events associated with testosterone replacement therapy to the Medication Guide.
  2. Add information regarding the natural rubber latex content of the bottle and applicator cup that is consistent with the FDA Final Guidance: Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.
06/19/2014 Modified to add the risk of venous thromboembolic events associated with testosterone use to the Medication Guide.
03/31/2011 Modified to revise the Medication Guide as described in the approval letter.
11/23/2010 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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