NORSPAN

What it is

NORSPAN is a buprenorphine transdermal patch 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. NORSPAN is a rectangular or square, beige-coloured transdermal matrix patch with rounded corners. Buprenorphine is a partial opioid agonist, acting at mu-opioid receptors.

Approved indications

NORSPAN 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. NORSPAN patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances.

Dosing overview

The lowest dose, NORSPAN patch 5 micrograms per hour, should be used as the initial dose. A maximum total dose of 40 micrograms per hour NORSPAN should not be exceeded. During the titration process, the dose may be adjusted every 3-days (72 hours). Thereafter, the 7-day dosing interval should be maintained. NORSPAN is for application to the skin (transdermal use) only over 7 days. Use in children is not recommended due to lack of clinical safety and efficacy data in patients under 18 years of age.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of NORSPAN patches. Practitioners should be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk 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 depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. NORSPAN patches pose risks of hazardous and harmful use which can lead to overdose and death. Assessment of the patient's risk of hazardous and harmful use should be undertaken before prescribing and the patient monitored regularly during treatment. Because of the risks associated with the use of opioids, NORSPAN patches should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain. Accidental exposure to NORSPAN patches, especially by children, can result in a fatal overdose of buprenorphine. Patients and their caregivers should be given information on safe storage and disposal of unused NORSPAN patches.

Contraindications

NORSPAN patches are contraindicated in patients with known hypersensitivity to buprenorphine or any components of the patch, myasthenia gravis, delirium tremens and pregnancy. NORSPAN 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. NORSPAN patches must not be used for the treatment of opioid dependence and opioid withdrawal.

PBS listing

NORSPAN transdermal patches are listed on the PBS in the following strengths: 15 mg, 25 mg, 30 mg and 40 mg. All strengths have authority required restriction. The 15 mg patch is listed with 2 items; the 25 mg, 30 mg and 40 mg patches each have 2 items with streamlined authority required restriction. Ex-manufacturer prices are A$16.04 for 15 mg, A$22.71 for 25 mg, A$25.95 for 30 mg and A$32.45 for 40 mg.

Regulatory history

NORSPAN was first registered on the ARTG on 9 May 2005 with the 5, 10 and 20 microgram per hour strengths, with the 15, 25, 30 and 40 microgram per hour strengths added on 28 November 2014. In November 2015, PBAC recommended listing of four additional strengths (15, 25, 30, 40 microgram per hour) on the general schedule as a Restricted Benefit listing for chronic severe disabling pain. In July 2016, PBAC recommended listing of all currently available strengths of buprenorphine transdermal patches on the Palliative Care Schedule as an Authority Required listing with a maximum quantity of 4 patches with two repeats, providing up to three months' supply.