APO-FENTANYL

What it is

APO-Fentanyl is a fentanyl matrix transdermal drug delivery system (patch). It is available in six different strengths delivering fentanyl 12, 25, 50, 75 or 100 micrograms/hour to the systemic circulation. APO-Fentanyl is a transparent rounded oblong unit comprising a protective liner and two functional layers.

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, and the pain is opioid-responsive, and severe enough to require daily, continuous, long term opioid treatment.

Dosing overview

The appropriate initiating dose of fentanyl should be based on the patient's current opioid use. Initiation of opioid treatment should be at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief. It is recommended that fentanyl be used in patients who have demonstrated opioid tolerance. To convert opioid tolerant patients from oral or parenteral opioids to fentanyl patches, refer to equianalgesic potency conversion and recommended fentanyl dose based on daily oral morphine dose. The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 micrograms/hour to achieve the lowest appropriate dose of fentanyl depending on response and supplementary analgesic requirements. The initial evaluation of the maximum analgesic effect of fentanyl should not be made before the patch has been worn for 24 hours. This is due to the gradual increase in serum fentanyl concentration in the 24 hours following initial application of the patch. Each fentanyl patch should be replaced every 72 hours.

Key safety warnings

APO-Fentanyl 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. APO-Fentanyl is not for use in opioid-naive patients. Serious, life-threatening or fatal respiratory depression may occur with the use of APO-Fentanyl. 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. The risk of life-threatening respiratory depression is also higher in elderly, frail, or debilitated patients and in patients with existing impairment of respiratory function (e.g. chronic obstructive pulmonary disease; asthma) and in patients with hepatic and renal impairment. 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. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Use of fentanyl transdermal system in the opioid naive patient has been associated with very rare cases of significant respiratory depression and/or fatality when used as initial opioid therapy. The potential for serious or life threatening hypoventilation exists even if the lowest dose of fentanyl transdermal system is used in initiating therapy in opioid naive patients, especially in elderly or patients with hepatic or renal impairment. APO-Fentanyl contains the opioid fentanyl and is a potential drug of abuse, misuse and addiction. Fentanyl can be abused in a manner similar to other opioids. Abuse or intentional misuse of fentanyl patches may result in overdose and/or death. Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed fentanyl. All patients receiving opioids should be routinely monitored for signs or misuse and abuse. 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. This is due to temperature dependent increases in fentanyl release from the patch and increased skin permeability.

Contraindications

APO-Fentanyl is contraindicated in patients with known hypersensitivity to fentanyl or to the adhesives present in the patch. Fentanyl should not be used in the following circumstances because serious or life-threatening hypoventilation may occur and can be fatal: the management of acute or postoperative pain since there is no opportunity for dose titration during short-term use; and in the management of mild or intermittent pain that can be managed by non-opioid analgesics or 'as required' dosing with short acting opioids; and at doses exceeding 25 micrograms/hour at the initiation of opioid therapy because of the need to individualise dosing by titrating to the desired analgesic effect. Severe respiratory disease, acute respiratory disease and respiratory depression are contraindications.

PBS listing

No source information is available regarding PBS listing details for APO-Fentanyl.

Regulatory history

APO-Fentanyl was first listed on the ARTG (Australian Register of Therapeutic Goods) on 22 December 2009 across five strengths: 12 micrograms/hour, 25 micrograms/hour, 50 micrograms/hour, 75 micrograms/hour and 100 micrograms/hour, all as transdermal drug delivery system sachets.