Return to Home Ensuring Appropriate Use Educating Patients Resources for Healthcare Professionals

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)
SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII)
SUBUTEX® (buprenorphine) Tablet (CIII)

Risk Evaluation and Mitigation Strategy (REMS)

The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for SUBOXONE Film, SUBOXONE Tablet, and SUBUTEX Tablet.

A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure that the benefits of a drug outweigh its risks.

The purpose of the SUBOXONE Film, SUBOXONE Tablet, and SUBUTEX Tablet REMS program is to inform healthcare professionals and patients about the safe use conditions and serious risks, including accidental overdose, misuse, and abuse, associated with buprenorphine-containing transmucosal products indicated for the treatment of opioid dependence.

The REMS program includes various materials and processes developed to assist in achieving the following 2 goals:

  • Mitigate the risk of accidental overdose, misuse, and abuse
  • Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE Film, SUBOXONE Tablet, and SUBUTEX Tablet

As a healthcare provider, you can take an active role in implementing REMS, which will help to:

  • Ensure the safe and proper use of SUBOXONE Film, SUBOXONE Tablet, and SUBUTEX Tablet
  • Monitor patients for misuse, abuse, and diversion
  • Address any issues that arise and allow you to adjust treatment protocols as necessary

Reference

  1. Data on file, Indivior Inc., Richmond, VA.

INDICATION

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII) is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

SUBUTEX® (buprenorphine) Tablet (CIII) is indicated for the treatment of opioid dependence and is preferred for induction. SUBUTEX Tablet should be used as part of a complete treatment plan to include counseling and psychosocial support.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION for SUBOXONE Film
IMPORTANT SAFETY INFORMATION for SUBOXONE Tablet
IMPORTANT SAFETY INFORMATION for SUBUTEX Tablet


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