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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:
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;
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);
Informing healthcare providers about the safe use of AVEED, including proper administration technique and patient observation; and
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.
Review the following: Education Program for Healthcare Providers.
Successfully complete the Knowledge Assessment and submit it to the
REMS Program.
Enroll in the REMS by completing the Healthcare Provider Enrollment Form
and submitting it to the REMS Program.
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.
Provide the patient with a copy of Patient Guide.
During treatment,
before each injection
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 Patient Guide. Provide a copy of
the Patient Guide to patient.
Patients who are prescribed Aveed:
Before treatment
initiation
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.
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.
After administration,
for 30 minutes
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.
Have the authorized representative enroll in the REMS Program by
completing the Healthcare Settings Enrollment Form and submitting it to
the REMS Program.
Train all relevant staff involved in dispensing Aveed using the Education
Program for Healthcare Settings.
Establish processes and procedures to verify that all healthcare providers
at the healthcare setting who prescribe Aveed are certified prior to
prescribing Aveed, each patient is counseled before administration of the
drug, and each patient is observed within the healthcare setting for
30 minutes following each injection.
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.
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.
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
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 USA, 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
distribute
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).
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
10/08/2024
Modified to include:
1) Updates to the REMS document, appended REMS materials, website
screenshots, and supporting document as a result of the change to the REMS
Administrator
2) Incorporation of the Endo name change into the REMS document and appended
materials.
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.
