BUPREDERMAL

What it is

BUPREDERMAL contains buprenorphine. BUPREDERMAL is a transdermal drug delivery system consisting of rectangular or square, beige-coloured transdermal matrix patches with rounded corners. BUPREDERMAL patches are available in seven strengths: 5 micrograms per hour, 10 micrograms per hour, 15 micrograms per hour, 20 micrograms per hour, 25 micrograms per hour, 30 micrograms per hour and 40 micrograms per hour. The patches are applied to the skin for transdermal use only, over 7 days.

Approved indications

BUPREDERMAL patches are indicated for the management of severe pain where other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, the pain is opioid-responsive, and requires daily, continuous, long-term treatment. BUPREDERMAL patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. BUPREDERMAL patches are not indicated as an as-needed (PRN) analgesia.

Dosing overview

The lowest dose, BUPREDERMAL patch 5 micrograms per hour, should be used as the initial dose. A maximum total dose of 40 micrograms per hour BUPREDERMAL should not be exceeded. No dosage adjustment is necessary in the elderly. During the titration process, the dose may be adjusted every 3 days. Thereafter, the 7-day dosing interval should be maintained. It is recommended that no more than two patches be applied at the same time, up to a maximum of 40 microgram per hour BUPREDERMAL.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of BUPREDERMAL patches, and the risk is greatest during initiation of therapy or following an increase in dose. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Patients should not drink alcohol while using BUPREDERMAL patches. BUPREDERMAL patches pose risks of hazardous and harmful use which can lead to overdose and death, and the patient's risk should be assessed before prescribing and monitored regularly during treatment. BUPREDERMAL contains the opioid buprenorphine and is a potential drug of abuse, misuse and addiction, and addiction can occur in patients appropriately prescribed BUPREDERMAL patches at recommended doses. Accidental exposure to BUPREDERMAL patches, especially by children, can result in a fatal overdose of buprenorphine, and patients and caregivers should be given information on safe storage and disposal. Hyperalgesia may occur with the use of opioids, particularly at high doses, and may manifest as an unexplained increase in pain or increased levels of pain with increasing opioid dosages. Higher dosages of BUPREDERMAL (40 micrograms per hour) are associated with a mean prolongation of the QTc interval of 5.9 milliseconds.

Contraindications

BUPREDERMAL patches are contraindicated in patients with known hypersensitivity to buprenorphine or any components of the patch, myasthenia gravis, delirium tremens and pregnancy. BUPREDERMAL patches are contraindicated in patients with severely impaired respiratory function, severe respiratory disease, acute respiratory disease and respiratory depression and in patients concurrently receiving non-selective monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with non-selective MAOIs. BUPREDERMAL patches must not be used for the treatment of opioid dependence and opioid withdrawal.

PBS listing

BUPREDERMAL transdermal patch 5 mg and 10 mg are listed on the PBS with streamlined and authority required restrictions, with ex-manufacturer prices of A$7.01 and A$12.62 respectively. BUPREDERMAL transdermal patch 20 mg is listed on the PBS with authority required and streamlined restrictions, with an ex-manufacturer price of A$19.47.

Regulatory history

BUPREDERMAL buprenorphine patches in all seven strengths (5, 10, 15, 20, 25, 30 and 40 micrograms per hour) were first listed on the ARTG on 7 September 2017.