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Approved Risk Evaluation and Mitigation Strategies (REMS)

Aveed (testosterone undecanoate)
NDA #022219
REMS last update: 05/26/2022



What is the purpose of the REMS?

The goals and the objectives of the AVEED REMS are to mitigate the negative outcomes associated with AVEED-induced pulmonary oil microembolism (POME) and anaphylaxis by:

  1. Ensuring that AVEED is dispensed only in certified healthcare settings that have immediate access on-site to equipment and personnel trained to manage POME and anaphylaxis;
  2. Informing healthcare providers that AVEED can cause POME and anaphylaxis, which have the potential to lead to serious medical consequences (e.g., respiratory distress and syncope);
  3. Informing healthcare providers about the safe use of AVEED, including proper administration technique and patient observation; and
  4. Informing patients about the risks of POME and anaphylaxis associated with AVEED and the importance of remaining at the healthcare setting for 30 minutes after each injection.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
05/26/2022 Modified to update the REMS supporting document and the website screenshots due to a website administrator change.
06/28/2021 Modified to update the What You Need to Know About Aveed Treatment: A Patient Guide and to add a Certified Healthcare Setting and Healthcare Provider lookup feature to the Aveed REMS website.
12/19/2018 Modified to revise the Aveed REMS enrollment website content that appears on the healthcare provider (HCP) enrollment screen.
09/01/2018 Modified to include a new REMS document and updated appended materials and REMS supporting document.
12/09/2016 Modified to establish a single shared system REMS for the elements to assure safe use required for the reference listed drug (RLD) Aveed and ANDAs referencing Aveed, called the Testosterone Undecanoate REMS Program, which will become applicable on the date of full approval of the first ANDA referencing Aveed.
03/05/2014 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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