Approved Risk Evaluation and Mitigation Strategies (REMS)

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Aveed (testosterone undecanoate)
NDA #022219
REMS last update: 12/09/2016



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

Healthcare Providers who prescribe Aveed

To be able to prescribe Aveed
Before writing the first prescription for a patient
  • Counsel the patient on the risks, including pulmonary oil microembolism (POME) and anaphylaxis, and the need to remain at the healthcare setting for 30 minutes following each injection.
  • Provide the patient with a copy of the What You Need to Know About Aveed Treatment: A Patient Guide.
    | What You Need to Know About Aveed Treatment: A Patient Guide |

Patients who receive Aveed

Before receiving the initial Aveed prescription
  • Receive counseling from the prescriber on the risks, including pulmonary oil microembolism (POME) and anaphylaxis, and the need to remain at the healthcare setting for 30 minutes following each injection.

Healthcare settings that dispense Aveed

To be able to dispense Aveed
  • Designate an authorized representative to carry out the certification process on behalf of the healthcare setting.
  • Have the authorized representative review the educational materials for dispensers, including: Education Program for Healthcare Settings.
    | Education Program for Healthcare Settings |
  • Ensure the healthcare setting has personnel and/or equipment on-site to manage pulmonary oil microembolism (POME) and anaphylaxis.
  • Train all relevant staff involved in the dispensing of Aveed.
  • Establish processes and procedures to verify that prescribers are certified.
  • Enroll in the REMS by completing and submitting the Healthcare Settings Enrollment Form.
    | Healthcare Setting Enrollment Form |
Before dispensing Aveed
After Aveed is administered
  • Assess patient’s vital signs by observation for 30 minutes following each injection.
Ongoing
  • Do not distribute, transfer, loan, or sell product except to certified dispensers.
  • Maintain records of current certified healthcare providers.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

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 Aveed REMS, see the DailyMed link(s).
Material Name Material Name Link
Education Program for Healthcare Providers (with Knowledge Assessment) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Education_Program_for_Healthcare_Providers_with_Knowledge_Assessment.pdf
Education Program for Healthcare Settings (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Education_Program_for_Healthcare_Settings.pdf
Healthcare Provider Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Healthcare_Provider_Enrollment_Form.pdf
Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Healthcare_Setting_Enrollment_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_Full.pdf
REMS Program: An Introduction (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_REMS_Program_An_Introduction.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_REMS_Website_Screenshots.pdf
What You Need to Know About Aveed Treatment: A Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2016-12-09_What_You_Need_to_Know_About_Aveed_Treatment_A_Patient_Guide.pdf

What updates have been made to the REMS?

Date Summary of change
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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