ACTIQ

What it is

ACTIQ is a fentanyl citrate lozenge with integral applicator available in strengths of 200, 400, 600, 800, 1200 and 1600 micrograms.

Approved indications

— Breakthrough pain in cancer patients.

Dosing overview

Dosage should be individualised according to individual patient factors and clinical response. The maximum quantity of 100 microgram and 200 microgram presentations is 20 tablets per script for dose titration in the initiation of treatment.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of fentanyl. Awareness of situations which increase the risk of respiratory depression, dose modification in patients at risk and close monitoring of patients, especially on initiation or following a dose increase, are essential. 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. Fentanyl 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. Accidental ingestion or exposure of ACTIQ, especially by children, can result in a fatal overdose of fentanyl.

Contraindications

Known hypersensitivity or intolerance to fentanyl, any of the components of ACTIQ or other opioid is a contraindication. ACTIQ should not be administered to patients suffering from bronchial asthma or severe respiratory disease, acute respiratory disease and those susceptible to respiratory depression, such as comatose patients who may have head injuries or brain tumour. Use of ACTIQ in patients who have received monoamine oxidase inhibitors within 14 days is not recommended. Myasthenia gravis contraindicates use due to the potential for fentanyl to cause muscle rigidity that may require reversal with muscle relaxants.

PBS listing

ACTIQ lozenges are listed on the PBS in strengths of 200, 400, 600 and 800 micrograms. The 200 microgram and 400 microgram strengths each have 2 PBS items, whilst the 600 microgram and 800 microgram strengths each have 1 PBS item. All listings require authority approval. Ex-manufacturer prices range from A$161.10 to A$221.87.

Regulatory history

ACTIQ was first registered on the ARTG on 15 November 2002, with six strengths (200, 400, 600, 800, 1200 and 1600 micrograms) all approved on the same date. In July 2017, the PBAC recommended an increase in the maximum quantity of 100 microgram and 200 microgram presentations from 10 to 20 tablets per script to facilitate dose titration in the initiation of treatment of cancer patients with breakthrough pain.