FENTORA

What it is

FENTORA is a synthetic opioid analgesic related to pethidine and with similar properties to morphine. FENTORA orally disintegrating tablets are available in five unit strengths equivalent to 100, 200, 400, 600 and 800 micrograms of fentanyl base. The tablets utilise an effervescent reaction to deliver the active substance when exposed to moisture.

Approved indications

— Treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.

Dosing overview

FENTORA should be individually titrated to an "effective" dose that provides adequate analgesia and minimises undesirable effects. The initial dose of FENTORA should be 100 micrograms, titrating upwards as necessary through the range of available tablets strengths (100, 200, 400, 600, 800 micrograms). During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second FENTORA tablet of the same strength may be used. Once an effective dose has been established during titration, patients should continue to take this dose as a single tablet of that given strength. Patients should wait at least 4 hours before treating another breakthrough pain episode with FENTORA during maintenance therapy, though the frequency may be increased under clinical supervision.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of FENTORA. 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. Limit dosages and durations to the minimum required and monitor patients for signs and symptoms of respiratory depression and sedation. FENTORA poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment. Accidental ingestion or exposure of FENTORA, especially by children, can result in a fatal overdose of fentanyl citrate. Patients and their caregivers should be given information on safe storage and disposal of unused FENTORA.

Contraindications

FENTORA is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, in patients without maintenance opioid therapy as there is an increased risk of respiratory depression, and in patients with severe respiratory disease, severe obstructive lung conditions, acute respiratory disease and respiratory depression. FENTORA is contraindicated for treatment of acute and chronic pain (including postoperative pain, headache, migraine) other than breakthrough cancer pain. FENTORA is contraindicated with simultaneous use of monoamine-oxidase inhibitors, or within 2 weeks after the cessation of the use of MAO inhibitors. FENTORA must not be used in opioid non-tolerant patients, as life-threatening respiratory depression could occur at any dose in patients not taking chronic opiates.

PBS listing

FENTORA is listed on the PBS in five strengths: 100 micrograms (two items), 200 micrograms (two items), 400 micrograms (one item), 600 micrograms (one item), and 800 micrograms (one item). All listings are restricted and require authority required approval. The ex-manufacturer prices are A$27.20 for 100 micrograms, A$190.40 for 200 micrograms, and A$120.26 for 400, 600 and 800 micrograms.

Regulatory history

FENTORA was first listed on the ARTG on 6 March 2015 in all five strengths (100, 200, 400, 600 and 800 micrograms).