What is the BTOD REMS?

The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD). 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 BTOD 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 BTOD 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 drug products subject to the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS include:

• Generic equivalents of Subutex^® (buprenorphine hydrochloride) sublingual tablet

• Generic equivalents of Suboxone^® (buprenorphine hydrochloride/naloxone hydrochloride) sublingual tablet

• Zubsolv^® (buprenorphine/naloxone) sublingual tablet

• Bunavail^® (buprenorphine hydrochloride/naloxone hydrochloride) buccal film

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 Guide for all buprenorphine-containing products.

For more information about the BTOD REMS, including all program materials and instructions call 1-855-223-3922.

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

To prescribe products covered under the BTOD REMS, a prescriber must be certified to treat opioid dependence under the Drug Addiction Treatment Act of 2000 (DATA 2000). For certification information, click here.

Click here for a complete list of products covered under the BTOD REMS program