Brixadi
Welcome to our BRIXADI REMS (Risk Evaluation and Mitigation Strategy) information page, designed to provide comprehensive details about the safe and effective use of BRIXADI in the treatment of moderate to severe opioid use disorder. At [Your Brand Name], we prioritize patient safety and regulatory compliance to ensure the best possible outcomes for our patients.
What is the BRIXADI REMS?
The BRIXADI REMS is a program mandated by the FDA (Food and Drug Administration) to manage known or potential risks associated with BRIXADI. It ensures that the benefits of the medication outweigh its risks and focuses on preventing serious harm or death that could result from misuse, particularly intravenous self-administration.
BRIXADI is specifically intended for subcutaneous injection by a healthcare provider and is available only through a restricted distribution system under the BRIXADI REMS. It must never be dispensed directly to patients but administered in a healthcare setting under the supervision of a qualified healthcare professional.
BRIXADI REMS Requirements
For Prescribers:
Certification: Prescribers are not required to be certified in the BRIXADI REMS to prescribe the medication.
Prescription Process: Prescribers can obtain BRIXADI for a named patient by writing a prescription and sending it to a REMS-certified pharmacy. The pharmacy coordinates delivery with the prescriber or the designated healthcare practitioner for administration.
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For Healthcare Settings/Pharmacies: Any healthcare setting or pharmacy that intends to keep a stock of BRIXADI must be certified in the BRIXADI REMS before purchasing or dispensing the medication. Certification involves designating an Authorized Representative responsible for training staff and ensuring compliance with dispensing protocols.
How to Obtain BRIXADI: Prescribers can obtain BRIXADI for their patients by sending a prescription to a REMS-certified pharmacy, which arranges delivery to coincide with the patient's scheduled appointment. BRIXADI is never dispensed directly to patients but administered by a healthcare professional in a healthcare setting.
Storage and Handling: BRIXADI should be stored at room temperature (20ºC to 25ºC or 68ºF to 77ºF) with controlled excursions permitted (15ºC to 30ºC or 59ºF to 86ºF). Due to its classification as a Schedule III drug, it should be handled with adequate security measures, and syringes should be disposed of according to facility protocols and regulatory guidelines.
More Information: For detailed information on the BRIXADI REMS, including enrollment forms, fact sheets, and educational resources, please visit the REMS@FDA website or contact the BRIXADI REMS Information Line at 1-866-492-9624. Healthcare providers are encouraged to report any adverse events associated with BRIXADI to the FDA or Braeburn Pharmaceuticals.
Indication: BRIXADI is indicated for the treatment of moderate to severe opioid use disorder as part of a comprehensive treatment plan that includes counseling and psychosocial support.