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The goal of the BRIXADI REMS is to mitigate the risk of serious harm or death that could result from
intravenous self-administration by:
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.
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).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
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.