AVEED® REMS (Risk Evaluation and Mitigation Strategy) Program
What is the AVEED REMS Program?
A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure the benefits of the drug outweigh its risks. The purpose of the AVEED REMS Program is to inform Healthcare Providers, Healthcare Settings and patients about the risks of:
- Serious pulmonary oil microembolism (POME) reactions
- Anaphylaxis
AVEED REMS Program Requirements
- Training — for Healthcare Providers and authorized representatives of Healthcare Settings on serious POME reactions and anaphylaxis associated with AVEED, safe use strategies, and REMS Program requirements.
- Certification — for Prescribing Healthcare Providers by completing training, Knowledge Assessment and enrollment into the AVEED REMS Program.
- Certification — for Healthcare Settings by completing training and enrollment into the AVEED REMS Program. Each Healthcare Setting must be certified in the AVEED REMS Program and have at least one certified prescriber associated with the facility to be able to order, receive, or administer AVEED.
- Patient counseling — about the risks of serious POME reactions and anaphylaxis. Healthcare Providers must give patients the Patient Counseling Tool: "What You Need to Know About AVEED Treatment: A Patient Guide."
- Patient observation — patients must remain in Healthcare Setting for 30 minutes after each AVEED injection.