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Approved Risk Evaluation and Mitigation Strategies (REMS)

Probuphine (buprenorphine hydrochloride)
NDA #204442
REMS last update: 11/01/2018



What is the purpose of the REMS?

The goal of the Probuphine REMS is to mitigate the risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse by:

  1. Ensuring that healthcare providers are educated on the following:
    • proper insertion and removal of Probuphine
    • risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine
    • risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin
  2. Ensuring pharmacies are certified and only provide Probuphine to healthcare settings in which a certified prescriber is practicing
  3. Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risk of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.

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

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
11/01/2018 Modified to make changes to the REMS document and materials to include pharmacy certification requirements.
04/19/2017 Modified to make modifications to the Probuphine REMS Program Surgical Procedures Recertification Transcript.
06/14/2016 Revised to correct a typographical error(s).
05/26/2016 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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