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CONTRAINDICATIONS

• Buprenorphine and naloxone sublingual tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.

WARNINGS AND PRECAUTIONS

The drug products subject to the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS¹ include:

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

¹ Buprenorphine hydrochloride sublingual tablets marketed under the trade name Subutex^® and buprenorphine hydrochloride/naloxone hydrochloride sublingual tablets and sublingual film marketed under the trade name Suboxone^® are covered under the Subutex and Suboxone REMS programs.

• These products, collectively referred to as “buprenorphine-containing products”, are delivered by the oral transmucosal route and are indicated for use during treatment of opioid dependence as 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.
• Buprenorphine-containing products must not be used by patients with hypersensitivity to buprenorphine, and/or naloxone in the case of combination products.
• Buprenorphine-containing products can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential.
• Children who ingest buprenorphine-containing products can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep buprenorphine-containing products out of the sight and reach of children.
• Buprenorphine-containing products can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (i.e., sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking buprenorphine-containing products. When buprenorphine-containing products are taken together with CNS depressants, dose reduction of either product(s) should be considered.
• Death has been reported in nontolerant, nondependent individuals who received a 2 mg dose for analgesia. The products covered under this REMS are not appropriate for use as an analgesic.
• Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) and may be delayed in onset. Intravenous misuse or taking buprenorphine-containing products before the effects of full-agonist opioids have subsided is highly likely to cause opioid withdrawal symptoms.
• Liver function should be monitored before and during treatment.
• Use of buprenorphine-containing products in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Neonatal withdrawal has been reported.
• Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.
• Adverse events most commonly observed with the sublingual administration of buprenorphine during clinical trials and post-marketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, and pain. An additional adverse event among those most commonly observed with sublingual administration of buprenorphine/naloxone formulations is peripheral edema.
• Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.
• This is not a complete list of potential adverse events associated with buprenorphine-containing products. Please see Full Prescribing Information of each specific product for a complete list.