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Approved Risk Evaluation and Mitigation Strategies (REMS)

Sublocade (buprenorphine extended-release)
NDA #209819
REMS last update: 04/19/2024



What is the purpose of the REMS?

The goal of the SUBLOCADE 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 SUBLOCADE 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 SUBLOCADE 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.
    | Healthcare Setting and Pharmacy Enrollment Form |
  • 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 SUBLOCADE 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
  • Verify that SUBLOCADE is dispensed directly to a healthcare provider and the drug is not dispensed to the patient.
  • Notify the healthcare provider not to dispense the drug directly to patients.
To maintain certification to dispense
At all times
  • Not distribute, transfer, loan or sell SUBLOCADE.
  • Maintain records of all processes and procedures including compliance with those processes and procedures.
  • Comply with audits by Indivior Inc. or a third party acting on behalf of Indivior Inc. to ensure that all processes and procedures are in place and are being followed.

Wholesalers/Distributors that distribute SUBLOCADE 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 SUBLOCADE 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 SUBLOCADE to Indivior Inc.
  • Comply with audits carried out by Indivior Inc. or a third party acting on behalf of Indivior 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 Sublocade REMS, see the DailyMed link(s).
Material Name Material Name Link
Fact Sheet How to Obtain Sublocade (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2024_04_19_Fact_Sheet_How_to_Obtain_Sublocade.pdf
Healthcare Provider REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2024_04_19_Healthcare_Provider_REMS_Letter.pdf
Healthcare Setting and Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2024_04_19_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2024_04_19_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2024_04_19_REMS_Full.pdf
REMS Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_2024_04_19_REMS_Website.pdf
Assessment Plan
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
04/19/2024 Modified to update the product storage conditions (from 7 days to 12 weeks) to align with currently approved labeling, affecting the following materials: Healthcare Provider REMS Letter, Fact Sheet: How to Obtain SUBLOCADE and REMS Website.
07/03/2023 Modified to align with the repeal of the Drug Addiction Treatment Act of 2000 (DATA-2000) through the enactment of the Mainstreaming Addiction Treatment (MAT) Act of 2021, thereby removing the DATA 2000 waiver requirement for qualifying practitioners in order to dispense certain narcotic drugs used for treatment of opioid use disorders.
01/27/2023 Revised to reflect editorial changes.
01/06/2023 Modified to change all of the REMS materials to clarify certification requirements, reorganize information for better understanding of the content, and change the healthcare setting audit requirement.
09/30/2021 Editorial change.
09/22/2021 Modified to make changes in response to recent updates with the Drug Enforcement Administration (DEA) interim final rule (IFR) published on November 2, 2020, that amended regulations for consistency with the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (the SUPPORT Act). REMS materials were updated to clarify that the pharmacy can deliver SUBLOCADE to either the prescribing practitioner or the practitioner administering the controlled substance, as applicable.Materials affected include the REMS Fact Sheet and the REMS Website.
12/02/2020 Revised to reflect editorial changes.
06/15/2020 Modified to change the REMS Document to update audit plans for healthcare settings and pharmacies.
01/28/2020 Revised to make an editorial change.
11/07/2019 Revised to make an editorial c hange.
03/08/2018 Editorial change.
02/09/2018 Revised to update mailing address.
11/30/2017 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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