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Approved Risk Evaluation and Mitigation Strategies (REMS)

Brixadi (buprenorphine)
NDA #210136
REMS last update: 05/23/2023



What is the purpose of the REMS?

The goal of the BRIXADI REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
  1. Ensuring healthcare settings and pharmacies are certified and only dispense BRIXADI directly to a healthcare provider for administration by a healthcare provider.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare settings and pharmacies that dispense BRIXADI must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy.
  • Have the authorized representative enroll in the REMS by completing the Healthcare Setting and Pharmacy Enrollment Form and submitting it to the REMS.
  • Train all relevant staff involved in dispensing that the drug must be dispensed directly to a healthcare provider for administration by a healthcare provider, and the drug must not be dispensed to the patient.
  • Establish processes and procedures to verify BRIXADI is dispensed directly to a healthcare provider and the drug is not dispensed to the patient.
  • Establish processes and procedures to notify the healthcare provider not to dispense the drug directly to patients.
Before dispensing
  • Notify the healthcare provider not to dispense the drug directly to patients.
To maintain certification to dispense
  • Have a new authorized representative enroll in the REMS by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form, if the authorized representative changes.
At all times
  • Not distribute, transfer, loan or sell BRIXADI.
  • Maintain records of all processes and procedures including compliance with those processes and procedures.
  • Comply with audits by Braeburn Inc. or a third party acting on behalf of Braeburn Inc. to ensure that all processes and procedures are in place and are being followed.

Wholesalers-Distributors that distribute BRIXADI must:

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified healthcare settings and pharmacies.
  • Train all relevant staff involved in distributing BRIXADI on the process and procedures to verify the healthcare settings and pharmacies are certified.
At all times
  • Distribute only to certified healthcare settings and pharmacies.
  • Maintain and submit records of all shipments of BRIXADI to Braeburn Inc.
  • Comply with audits carried out by Braeburn Inc. or a third party acting on behalf of Braeburn Inc. to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Brixadi REMS, see the DailyMed link(s).
Material Name Material Name Link
Healthcare Setting and Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf
Fact Sheet: How to Obtain BRIXADI (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_Fact_Sheet_How_to_Obtain_BRIXADI.pdf
Healthcare Provider REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_Healthcare_Provider_REMS_Letter.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Brixadi_2023_05_23_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ Brixadi_2023_05_23_REMS_Website_Screenshot.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
05/23/2023 Approval of the REMS

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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