B-PATCH

What it is

B-PATCH is a buprenorphine matrix transdermal drug delivery system (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. B-PATCH is a pale yellowish-brown rectangular patch with rounded edges. The amount of buprenorphine released from each system per hour is proportional to the surface area of the patch.

Approved indications

— 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.

Dosing overview

The lowest dose, B-PATCH 5 micrograms per hour, should be used as the initial dose, and a maximum total dose of 40 micrograms per hour should not be exceeded. Consideration should be given to the previous opioid history of the patient, including opioid tolerance, if any, as well as current general condition and medical status of the patient. The dose of B-PATCH should not be increased at less than 3-day intervals when steady state levels are attained and the maximum effect of a given dose is established, and thereafter the 7-day dosing interval should be maintained. B-PATCH is applied over 7 days.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of B-PATCH, and patients should be monitored closely for respiratory depression, especially on initiation or following a dose increase. The risk of life-threatening respiratory depression is higher in elderly, frail, or debilitated patients, in patients with hepatic impairment and in patients with existing impairment of respiratory function such as chronic obstructive pulmonary disease or asthma, and opioids should be used with caution and with close monitoring in these patients. 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, and dosages and durations should be limited to the minimum required with close monitoring for signs and symptoms of respiratory depression and sedation. B-PATCH contains the opioid buprenorphine and is a potential drug of abuse, misuse and addiction, and addiction can occur in patients appropriately prescribed B-PATCH at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse, mental illness or in current tobacco users, and the risk increases the longer the drug is used and with higher doses. Hyperalgesia may occur with the use of opioids, particularly at high doses, and may manifest as an unexplained increase in pain, increased levels of pain with increasing opioid dosages or diffuse sensitivity not associated with the original pain.

Contraindications

B-PATCH is contraindicated in patients with known hypersensitivity to buprenorphine or any components of the patch, myasthenia gravis, delirium tremens and pregnancy. B-PATCH is 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.

Regulatory history

B-PATCH was first registered on the ARTG on 11 November 2021 with initial listings for the 5 micrograms per hour, 10 micrograms per hour, 15 micrograms per hour and 20 micrograms per hour strengths. The 25 micrograms per hour, 30 micrograms per hour and 40 micrograms per hour strengths were added to the ARTG on 2 November 2023.