Approved Risk Evaluation and Mitigation Strategies (REMS)
Suboxone/Subutex (buprenorphine and naloxone/buprenorphine)
NDA #020733
NDA #022410
NDA #020732
REMS last update: 12/02/2020
- View the Suboxone/Subutex Prescribing Information at DailyMed
- View Suboxone/Subutex's Regulatory Information at Drugs@FDA
- View the Suboxone/Subutex Prescribing Information and Medication Guide at DailyMed.
- View Suboxone/Subutex's Regulatory Information at Drugs@FDA
- View Suboxone/Subutex's Regulatory Information at Drugs@FDA
What is the purpose of the REMS?
The goals of the REMS for SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets.
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
Healthcare providers who prescribe or dispense Suboxone/Subutex must:
Before treatment initiation (first dose) |
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During treatment; at the first visit following induction |
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During treatment; at a return visit scheduled at intervals commensurate with patient stability |
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Patients who are prescribed Suboxone/Subutex must:
Before the first prescription |
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During treatment, at a time interval determined by your prescriber |
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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.
Material Name | Material Name Link |
---|---|
Appropriate Use Checklist (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Appropriate_Use_Checklist.pdf |
Dear Pharmacist Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Dear_Pharmacist_Letter.pdf |
Dear Prescriber Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Dear_Prescriber_Letter.pdf |
Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists ( (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Pharmacists.pdf |
Office Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_Office_Based_Buprenorphine_Therapy_for_Opioid_Dependence_Important_Information_for_Prescribers .pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_REMS_Full.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_12_02_REMS_Website_Screenshots.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
12/02/2020 | Revised to make editorial changes. |
10/01/2020 | Revised to make editorial changes to the REMS materials. |
03/02/2020 | Modified the REMS Document to the new format in accordance with the October 2017 Draft Guidance: Format and Content of a REMS Document Guidance for Industry. |
01/24/2020 | Revised to reflect editorial changes. |
10/26/2018 | Modified to align the REMS document and materials with the safety labeling changes approved on February 1, 2018. Those labeling changes pertained to the risks of life-threatening respiratory depression and death with concomitant use of buprenorphine with benzodiazepines or other CNS depressants, and additional revisions to the Package Insert. |
06/11/2018 | Modified to include the authorized generic of SUBOXONE sublingual film. |
09/19/2017 | Modified the following REMS materials to be consistent with the safety labeling changes approved on December 16, 2016:
|
07/07/2016 | Modified to provide more succinct and clear risk information for prescribers and pharmacists in the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists Brochure, the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers Brochure, the Appropriate Use Checklist, the Dear Prescriber Letter, and the Dear Pharmacist Letter. |
09/22/2015 | 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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