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) Sublingual Tablet (CIII)

Risk Evaluation and Mitigation Strategy (REMS)

What is the SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets REMS?

The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets. A REMS is a strategy to mitigate 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.

What products are covered under SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets?

Buprenorphine-containing products are available both as products containing the single active ingredient, buprenorphine, and products that combine buprenorphine with naloxone; both types of products are indicated for the treatment of opioid dependence.

The following products are covered under SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets:

  • SUBOXONE® (buprenorphine/naloxone) sublingual film
  • SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride) sublingual tablet
  • SUBUTEX® (buprenorphine hydrochloride) sublingual tablet

The use of buprenorphine-containing products should be part of a comprehensive treatment plan to include counseling and psychosocial support. Treatment must be initiated under the direction of prescribers qualified under the Drug Addiction Treatment Act of 2000.

Where can I obtain additional information?

Please see the Prescribing Information and Medication Guides for all three buprenorphine-containing products.

For more information about SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets, including all program materials and instructions call 1-866-463-4846 or visit

General information about buprenorphine treatment and the treatment of addiction are available through numerous sources, including but not limited to:


You are leaving

Links are provided as a public service and for informational purposes only. No endorsement is made or implied. Clicking on "Continue" will take you to a website that is outside the control of Indivior Inc. You are solely responsible for your interactions with such websites.

Continue Cancel button

As always, the information you give us will not be sold or shared with anyone. Please see our privacy policy for more information.

The requested information is provided in Portable Document Format (PDF). To view and print this document you'll need to install a copy of the free Adobe® Acrobat® Reader®. If you already have Adobe Acrobat Reader installed click "VIEW PDF" below. If you need the Acrobat Reader you can download it from the Adobe Acrobat Reader Download page.

View PDFCancel button

Don't show me this message again.