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Jul 24 2017

REMS Program #suboxone # #(buprenorphine #and #naloxone) #sublingual #film #(ciii); #rems #program; #risk #evaluation #and

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

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 the SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets REMS Program:

  • 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 the SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets REMS, including all program materials and instructions call 1-866-463-4846 or visit www.SuboxoneREMS.com

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

  • SAMHSA website (www.dpt.samhsa.gov )
  • American Society of Addiction Medicine website (www.asam.org )
  • American Academy of Addiction Psychiatry website (www.aaap.org )

To report SUSPECTED ADVERSE EVENTS, contact:

  • The manufacturer of the product taken or
  • FDA MedWatch program by phone at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm




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