Approved Risk Evaluation and Mitigation Strategies (REMS)

Aveed (testosterone undecanoate)

NDA #022219

REMS last update: 05/26/2022

• View the Aveed Prescribing Information and Medication Guide at DailyMed.
• View Aveed's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

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

Healthcare Providers who prescribe Aveed must:

To become certified to prescribe	Review Aveed’s Prescribing Information. Review the following: Education Program for Healthcare Providers. | Education Program for Healthcare Providers | Successfully complete the Knowledge Assessment and submit it to the REMS Program. | Knowledge Assessment | Enroll in the REMS by completing the Healthcare Provider Enrollment Form and submitting it to the REMS Program. | Healthcare Provider Enrollment Forms |
Before treatment initiation (first dose)	Counsel the patient on the risks, including pulmonary oil embolism (POME) and anaphylaxis, and the need to remain at the healthcare setting for 30 minutes following each injection using the Patient Guide. | What You Need to Know About Aveed Treatment: A Patient Guide | Provide the patient with a copy of Patient Guide. | What You Need to Know About Aveed Treatment: A Patient Guide |
During treatment, before each injection	Counsel the patient on the risks, including pulmonary oil embolism (POME) | What You Need to Know About Aveed Treatment: A Patient Guide |

Patients who are prescribed Aveed:

Before treatment	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 using Patient Guide. | What You Need to Know About Aveed Treatment: A Patient Guide |
Before administering	Receive counseling on risks, including POME and anaphylaxis, and the need to remain at the healthcare setting for 30 minutes following each injection from the prescriber using Patient Guide. | What You Need to Know About Aveed Treatment: A Patient Guide |
After administration,	Be monitored for pulmonary oil embolism (POME) or anaphylaxis by remaining at the healthcare setting after the injection.

Healthcare settings that dispense Aveed must:

To become certified to dispense	Have immediate access to the necessary equipment and personnel to manage POME and anaphylaxis on-site. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the healthcare setting. Have the authorized representative review the Education Program for Healthcare Settings. | Education Program for Healthcare Settings | Have the authorized representative enroll in the REMS Program by completing the Healthcare Settings Enrollment Form and submitting it to the REMS Program. | Healthcare Setting Enrollment Forms | Train all relevant staff involved in dispensing Aveed using the Education Program for Healthcare Settings. | Education Program for Healthcare Settings | Establish processes and procedures to verify that all healthcare providers
Before dispensing	Verify the prescriber is certified.
Before administering	Counsel the patient on the risk of POME and anaphylaxis. Provide the patient with a copy of the Patient Guide. | What You Need to Know About Aveed Treatment: A Patient Guide |
After administering, for 30 minutes	Assess the patient for POME and anaphylaxis.
To maintain certification to dispense	Have a new authorized representative enroll in the REMS Program by completing the Healthcare Settings Enrollment Form if the authorized representative changes. | Healthcare Setting Enrollment Forms |
To maintain certification to dispense, every 2 years	Have authorized representative review the Education Program for Healthcare Settings Have the authorized representative re-enroll in the REMS Program by completing the Healthcare Settings Enrollment Form | Healthcare Setting Enrollment Forms |
At all times	Not distribute, transfer, loan, or sell Aveed, except to certified dispensers with the same authorized representative. Maintain records of staff training and certified prescribers. Comply with audits carried out by Endo Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute Aveed must:

To be able to	Establish processes and procedures to ensure that the drug is distributed only to certified healthcare settings that have one or more certified prescribers associated with that address.
At all times	Distribute only to certified healthcare settings that have one or more certified prescribers associated with that address. Maintain records of all shipments of Aveed.

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 (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Education_Program_for_Healthcare_Providers.pdf
Education Program for Healthcare Settings (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_Education_Program_for_Healthcare_Settings.pdf
Healthcare Provider Enrollment Forms (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_Healthcare_Provider_Enrollment_Form.pdf
Healthcare Setting Enrollment Forms (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_Healthcare_Setting_Enrollment_Form.pdf
Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_Knowledge_Assessment.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Full.pdf
REMS Program: An Introduction (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Program_An_Introduction.pdf
REMS Website (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_REMS_Website.pdf
What You Need to Know About Aveed Treatment: A Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2022_05_26_What_You_Need_to_Know_About_Aveed_Treatment_A_Patient_Guide.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
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.