Approved Risk Evaluation and Mitigation Strategies (REMS)

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Aveed (testosterone undecanoate)
NDA #022219
REMS last update: 03/05/2014

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

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
  • Review the prescribing information for Aveed.
  • Complete the Education Program for Healthcare Providers, including the knowledge assessment.
  • Enroll in the REMS by completing and submitting the Healthcare Provider Enrollment Form.
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.

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.
  • 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.
Before dispensing Aveed
  • Counsel the patient on the risk of POME and anaphylaxis.
  • Provide the patient with a copy of the What You Need To Know About Aveed Treatment: A Patient Guide.
  • Verify that the prescriber is certified.
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:


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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