The Aveed REMS Program is a risk evaluation and mitigation strategy program designed to manage the potential serious risks associated with the drug product AVEED. It aims to inform healthcare providers, healthcare settings, and patients about the risks of serious pulmonary oil microembolism (POME) reactions and anaphylaxis, while providing training, certification, and patient counseling to ensure safe use of AVEED.
The program requires healthcare providers and healthcare settings to undergo training and certification, with at least one certified prescriber associated with each certified healthcare setting. Patients receiving AVEED treatment are required to remain in the healthcare setting for 30 minutes after each injection, and healthcare providers must provide them with a patient counseling tool to educate them about the risks associated with the drug.
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