Welcome to the BRIXADI REMS

(Risk Evaluation and Mitigation Strategy)

What is the BRIXADI REMS (Risk Evaluation and Mitigation Strategy)?

A REMS is a strategy to manage known or potential risks associated with a drug, and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. BRIXADI is intended for subcutaneous injection only by a healthcare provider and is only available through a restricted distribution program called the BRIXADI REMS. BRIXADI must never be dispensed directly to the patient and must only be administered by a healthcare professional in a healthcare setting. The goal of the REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration.

BRIXADI REMS Requirements

PRESCRIBERS

1. Prescribers are NOT required to be certified in the BRIXADI REMS to prescribe BRIXADI.

2. Prescribers can obtain BRIXADI for a specific named patient’s scheduled appointment by writing a prescription and sending it to a REMS-certified pharmacy. The REMS-certified pharmacy coordinates delivery to the prescriber or the practitioner administering BRIXADI with the patient’s appointment date.

3. Prescribers that intend to keep a supply of BRIXADI in stock at their healthcare setting and obtain BRIXADI from a distributor, must certify their healthcare setting or practice in the BRIXADI REMS. See below.

HEALTHCARE SETTINGS*/PHARMACIES

Any healthcare setting* (including a prescriber office) or pharmacy that intends to keep a supply of BRIXADI in stock and order BRIXADI directly from an authorized distributor must be certified in the BRIXADI REMS prior to purchasing/dispensing BRIXADI.

* Examples of healthcare settings include: group practice, independent practice, institution, Department of Defense (DoD) facility, outpatient clinic, hospital, Veterans Administration (VA) facility, opioid treatment program (OTP), closed healthcare system, and other healthcare settings.

How does a healthcare setting or pharmacy become certified in the BRIXADI REMS?

To become certified in the BRIXADI REMS, healthcare settings and pharmacies must:

1. Designate an Authorized Representative that agrees to:

  • Train all relevant staff at each dispensing location involved in the dispensing of BRIXADI directly to a healthcare provider, to ensure that the drug is not dispensed directly to a patient.
  • Establish processes and procedures to verify that BRIXADI is dispensed directly to a healthcare provider. BRIXADI must never be dispensed directly to a patient.
  • Establish processes and procedures to notify the healthcare provider not to dispense BRIXADI directly to patients.

2. Complete the REMS enrollment process by filling out and signing the Healthcare Setting and Pharmacy Enrollment Form

 

Does a prescriber that wants to have BRIXADI administered to a named patient at their scheduled appointment need to certify? How can healthcare providers obtain BRIXADI for their patients?

Prescribers do not need to certify in the REMS. In advance of the patient’s appointment, send a prescription for the named patient to a certified pharmacy. REMS-certified pharmacies can be found here or by calling 1-866-492-9624. The pharmacy will coordinate delivery with the patient’s scheduled appointment and deliver to the prescriber or the administering practitioner designated by the prescriber. BRIXADI is never dispensed directly to the patient and must only be administered by a healthcare professional in a healthcare setting.

 

Does a prescriber that wants to keep a bulk supply of BRIXADI in stock at their office need to certify? How does a prescriber obtain BRIXADI?

The prescriber’s office/healthcare setting must certify in the REMS and obtain BRIXADI through an authorized distributor.

 

How should BRIXADI be stored?

Once BRIXADI is delivered for a named patient or is obtained for a healthcare setting’s bulk supply:

  • Store BRIXADI at room temperature at 20ºC to 25ºC (68ºF to 77ºF); with excursions permitted at 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
  • BRIXADI is a Schedule III drug product. Handle with adequate security and accountability. After administration, syringes should be properly disposed per facility procedure for a Schedule III drug product and per applicable federal, state, and local regulations.

Where can healthcare settings and pharmacies find more information about the BRIXADI REMS?

To access the current list of certified pharmacies where you can obtain BRIXADI, you can call BRIXADI REMS at 1-866-492-9624 or click here.

Indication

BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Reporting Adverse Events

Healthcare providers are encouraged to report adverse events to the FDA. Healthcare providers should report all cases of intravenous administration and suspected adverse events associated with BRIXADI to the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm or to Braeburn at 1-833-274-9234 or send information to [email protected].