DUROGESIC

What it is

DUROGESIC is a fentanyl matrix transdermal system (patch) designed to release fentanyl continuously for 72 hours after application to intact skin. It is available in five different strengths delivering 12, 25, 50, 75 or 100 micrograms/hour fentanyl to the systemic circulation.

Approved indications

— Management of pain associated with cancer, palliative care, and other conditions in patients 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 severe enough to require daily, continuous, long term opioid treatment.

Dosing overview

The appropriate initiating dose of DUROGESIC should be based on the patient's current opioid use, initiated at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief, considering the patient's current general condition and medical status, including body size, age and extent of debilitation as well as degree of opioid tolerance. The dosage may be titrated upwards or downwards in increments of either 12 or 25 micrograms/hour to achieve the lowest appropriate dose depending on response and supplementary analgesic requirements. Each DUROGESIC patch should be worn continuously for 72 hours. After an increase in dose, it may take up to 6 days for the patient to reach equilibrium on the new dose level; patients should wear the higher dose patch through two 72-hour applications before increasing the dose further.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of DUROGESIC; healthcare 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 DUROGESIC 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, patients monitored for signs and symptoms of respiratory depression and sedation, and patients cautioned not to drink alcohol while taking DUROGESIC. DUROGESIC poses risks of hazardous and harmful use which can lead to overdose and death; the patient's risk of hazardous and harmful use should be assessed before prescribing and the patient monitored regularly during treatment. DUROGESIC contains the opioid fentanyl and is a potential drug of abuse, misuse and addiction; fentanyl can be abused in a manner similar to other opioid agonists, and abuse or intentional misuse of DUROGESIC may result in overdose and/or death. Based on a pharmacokinetic model, serum fentanyl concentrations could theoretically increase by approximately one third for patients with a body temperature of 40°C, resulting in possible overdose and death due to temperature-dependent increases in fentanyl release from the patch and increased skin permeability; patients wearing DUROGESIC patches who develop fever should be monitored for opioid side effects and the dose adjusted if necessary, and all patients should be advised to avoid exposing the DUROGESIC patch to direct external heat sources. Used patches may be retrieved and used accidentally by children or deliberately by people with substance use disorders; therefore used patches must be disposed of carefully, the contents of disposed patches may be retrieved and ingested or injected by people with substance use disorders, deaths have occurred as a result of such abuse, and used patches must be concealed and disposed of carefully.

Contraindications

DUROGESIC is contraindicated in patients with known hypersensitivity to fentanyl or to the adhesives present in the patch. DUROGESIC should not be used in the management of acute or post-operative pain since there is no opportunity for dose titration during short term use, in the management of mild or intermittent pain that can be managed by non-opioid analgesics or short acting opioids, at doses exceeding 25 micrograms/hour at the initiation of opioid therapy, or in patients with severe respiratory disease, acute respiratory disease and respiratory depression.

PBS listing

Information regarding PBS listing, including strength, item count, restriction type and ex-manufacturer price, is not available in the provided source documents.

Regulatory history

DUROGESIC fentanyl transdermal patches in five strengths (12, 25, 50, 75 and 100 micrograms/hour) were first registered on the Australian Register of Therapeutic Goods on 23 November 2005 under licence category RE, sponsored by Janssen-Cilag.