SUBOXONE FILM

What it is

SUBOXONE FILM contains buprenorphine (as hydrochloride) and naloxone (as hydrochloride dihydrate) at a ratio of 4:1 buprenorphine: naloxone (ratio of free bases). SUBOXONE FILM is available in four dosage strengths: 2 mg buprenorphine (as hydrochloride) + 0.5 mg naloxone (as hydrochloride dihydrate); 4 mg buprenorphine (as hydrochloride) + 1 mg naloxone (as hydrochloride dihydrate); 8 mg buprenorphine (as hydrochloride) + 2 mg naloxone (as hydrochloride dihydrate); and 12 mg buprenorphine (as hydrochloride) + 3 mg naloxone (as hydrochloride dihydrate). SUBOXONE FILM is a soluble film intended for sublingual and or buccal administration only.

Approved indications

— Treatment of opioid dependence within a framework of medical, social and psychological treatment.

Dosing overview

Treatment with SUBOXONE FILM is intended for adults and children aged 16 years or over who have agreed to be treated for opioid dependence. The routes of administration of SUBOXONE FILM is sublingual and buccal only. Physicians must advise patients that the sublingual and buccal route are the only effective and safe route of administration for this medicine. For patients using heroin or other short-acting opioids, the recommended starting dose is 4–8 mg SUBOXONE FILM on Day One, with a possible additional 4 mg depending on the individual patient's requirement. The suggested target total dose for Day One is in the range of 8–12 mg SUBOXONE FILM. For patients on methadone, an initial dose of 2 mg SUBOXONE FILM may be administered when moderate withdrawal is apparent. An additional dose of 6 mg SUBOXONE FILM can be administered one hour later if the initial dose does not precipitate withdrawal. The suggested target total dose for Day One is in the range of 8–16 mg SUBOXONE FILM. A maximum daily dose of 32 mg should not be exceeded. Most patients require daily buprenorphine doses in the range 12–24 mg to achieve stabilisation, although some patients require higher (e.g. up to 32 mg/day) or lower (4–8 mg/day) doses to achieve their treatment goals.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of SUBOXONE FILM. Be aware of situations which increase the risk of respiratory depression, and monitor patients closely, especially on initiation or following a dose increase. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Although SUBOXONE FILM is indicated for the treatment of opioid dependence it still poses risks of hazardous and harmful use which can lead to overdose and death. Monitor the patient's ongoing risk of hazardous and harmful use regularly during opioid substitution therapy with SUBOXONE FILM. SUBOXONE FILM may cause severe, possible fatal, respiratory depression in children who accidentally ingest it. Protect children against exposure.

Contraindications

Hypersensitivity to buprenorphine or naloxone or any other component of the soluble film. Children less than 16 years of age. Severe respiratory or hepatic insufficiency (Child-Pugh C). Acute intoxication with alcohol or other CNS depressant.

Regulatory history

SUBOXONE FILM was approved by the TGA on 2010-12-07 for the treatment of opiate dependence. The TGA evaluation found that the Suboxone Sublingual Film formulation resulted in significantly greater bioavailability for both buprenorphine and naloxone compared to the existing sublingual tablets. Initial concerns regarding the extreme instability of naloxone in the film and the resulting high levels of impurities were addressed, with the proposed impurity limits ultimately deemed adequately qualified. SUBOXONE FILM 8/2 and 2/0.5 were first listed on the ARTG on 2011-02-18, with SUBOXONE FILM 12/3 and 4/1 first listed on 2014-05-20.