Risk Evaluation and Mitigation Strategies (REMS) Summary

Goals of the Aveed (testosterone undecanoate) REMS Program

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.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms