HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BUNAVAIL safely and effectively. See full prescribing information for BUNAVAIL.
BUNAVAIL (buprenorphine and naloxone) buccal film, CIII
Initial U.S. Approval: 2002
INDICATIONS AND USAGE
BUNAVAIL is a partial opioid agonist indicated for the maintenance treatment of opioid dependence. Prescription use of this product is limited under the Drug Addiction Treatment Act. (1)
DOSAGE AND ADMINISTRATION
Apply BUNAVAIL buccal film as a single daily dose. (2) The recommended daily dose for maintenance is 8.4 mg/1.4 mg.
DOSAGE FORMS AND STRENGTHS
Buccal film: BUNAVAIL 2.1 mg buprenorphine/0.3 mg naloxone; BUNAVAIL 4.2 mg buprenorphine/0.7 mg naloxone and BUNAVAIL 6.3 mg buprenorphine/1 mg naloxone. (3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine or naloxone. (4)
WARNINGS AND PRECAUTIONS
Buprenorphine can be abused in a similar manner to other opioids. Clinical monitoring appropriate to the patient’s level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. (5.1)
Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). (5.2)
Consider dose reduction of CNS depressants, BUNAVAIL buccal film, or both in situations of concomitant prescription. (5.3)
Store BUNAVAIL buccal film safely and out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children. (5.4)
Chronic administration produces opioid-type physical dependence. Abrupt discontinuation or rapid dose taper may result in opioid withdrawal syndrome. (5.5)
Monitor liver function tests prior to initiation and during treatment and eva luate suspected hepatic events. (5.6)
Do not administer BUNAVAIL buccal film to patients with known hypersensitivity to buprenorphine or naloxone. (5.7)
An opioid withdrawal syndrome is likely to occur with parenteral misuse of BUNAVAIL buccal film by individuals physically dependent on full opioid agonists or by buccal administration before the agonist effects of other opioids have subsided. (5.8)
Neonatal withdrawal has been reported following use of buprenorphine by the mother during pregnancy. (5.9)
BUNAVAIL buccal film is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a buprenorphine dose smaller than the lowest available BUNAVAIL strength. (5.10)
Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment (5.11)
Caution patients about the risk of driving or operating hazardous machinery. (5.12)
ADVERSE REACTIONS
Adverse events commonly observed with administration of BUNAVAIL buccal films during clinical trials are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia and pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact (BioDelivery Sciences International) at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Monitor patients starting or ending CYP3A4 inhib