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
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
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:
To report SUSPECTED ADVERSE EVENTS, contact:
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 for a complete
list of products covered under the BTOD REMS program