Approved Risk Evaluation and Mitigation Strategies (REMS)

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Sublocade (buprenorphine extended-release)
NDA #209819
REMS last update: 03/08/2018



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 dispense and oversee implementation and compliance with the REMS Program on behalf of the healthcare setting or pharmacy
  • Have the authorized representative enroll in the REMS Program by completing the Healthcare Setting and Pharmacy Enrollment Form and submitting it to the REMS Program
    | 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 to ensure that all processes and procedures are in place and are being followed for the Sublocade REMS Program.

Wholesalers/Distributors that distribute Sublocade must

To be ale 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.
  • Comply with audits carried out by Indivior or a third party acting on behalf of Indivior 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 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Fact_Sheet.pdf
Healthcare Provider Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Healthcare_Provider_Letter.pdf
Healthcare Setting and Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Healthcare_Setting_and_Pharmacy_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_8_2018_REMS_Full.pdf
Website Screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Sublocade_3_08_2018_Website-Screenshot.pdf

What updates have been made to the REMS?

Date Summary of change
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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