The AVEED REMS will transition to a new system, tentatively scheduled to occur over the weekend beginning October 11th. During this time, our contact center and website will be temporarily unavailable beginning at 3:00 PM ET on Friday, October 11th and will resume operation at 8:00 AM ET on Monday, October 14th.
The AVEED REMS website address (www.AVEEDREMS.com), contact phone number (1-855-755-0494), and fax number (1-855-755-0495) will remain unchanged. Upon completion of the system upgrade, users may notice some enhancements to the appearance and functionality of the website.
Important: Starting October 14th, all users that currently access the AVEED REMS website will be required to reset their passwords as part of the enhanced security measures. Instructions for this process will be communicated via email around that date.
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.