Approved Risk Evaluation and Mitigation Strategies (REMS)

Suboxone/Subutex (buprenorphine and naloxone/buprenorphine)

NDA #020733 NDA #022410 NDA #020732

REMS last update: 03/02/2020

Goals
Summary
REMS Materials
Update history

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)	Assess the patient's condition to verify the patient meets the diagnostic criteria for opioid dependence. Counsel the patient on the risks described in the professional information and Medication Guide and safe storage of the medication. Complete the Appropriate Use Checklist. Retain a completed copy in the patient's record or by using another method (e.g. electronic health record) specific to the prescriber's office practice.
During treatment; at the first visit following induction	Prescribe a limited amount of medication.
During treatment; at a return visit scheduled at intervals commensurate with patient stability	Assess the patient's compliance with the prescribed medication, appropriateness of the dosage prescribed, whether patient is receiving the necessary psychosocial support, and whether patient is making adequate progress towards treatment goals. Complete the Appropriate Use Checklist. Retain a completed copy in the patient's record or by using another method (e.g. electronic health record) specific to the prescriber's office practice.

Patients who are prescribed Suboxone/Subutex

Before the first prescription	Receive counseling from the prescriber on the risks and safe storage of the medication.
During treatment; at a time interval determined by your prescriber	Be monitored for compliance with the prescribed medication, appropriateness of the dosage prescribed, assessment of whether receiving the necessary psychosocial support, and whether making adequate progress towards treatment goals.

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_03_02_Appropriate_Use_Checklist.pdf
Dear Pharmacist Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_Dear_Pharmacist_Letter.pdf
Dear Prescriber Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_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_03_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_03_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_03_02_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Suboxone_Subutex_2020_03_02_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date	Summary of change
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: the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers Brochure the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists Brochure the Dear Prescriber Letter the Dear Pharmacist Letter the Appropriate Use Checklist the REMS website
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.

Suboxone/Subutex (buprenorphine and naloxone/buprenorphine) NDA #020733 NDA #022410 NDA #020732 REMS last update: 03/02/2020