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 |
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REMS document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Axiron_2017_07_13_REMS_document.pdf |
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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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:
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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.