ABSTRAL

What it is

ABSTRAL is a fentanyl (as citrate) sublingual tablet . It is an opioid analgesic indicated for a specific use in cancer pain management. The tablets are available in strengths of 100, 200, 300, 400, 600, or 800 micrograms .

Approved indications

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

Dosing overview

ABSTRAL should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain. Patients can be considered opioid tolerant if they take at least 60 mg of oral morphine daily or an equianalgesic dose of another opioid for a week or longer. ABSTRAL sublingual tablets should be administered directly under the tongue at the deepest part and should not be swallowed, but allowed to completely dissolve in the sublingual cavity without chewing or sucking. The initial dose of ABSTRAL used should be 100 micrograms, titrating upwards as outlined below. All patients must initiate therapy with a single 100 microgram sublingual tablet. If adequate analgesia is achieved within 30 minutes of administration of a single dose, no titration is required and this dose should be used as the maintenance dose for the next breakthrough cancer pain episodes. Dose escalation should continue in this stepwise manner for subsequent breakthrough cancer pain episodes until adequate analgesia with tolerable adverse reactions is achieved. The efficacy and safety of doses higher than 800 micrograms have not been evaluated in clinical studies; therefore, doses higher than 800 micrograms are not recommended. Patients should not take more than four (4) ABSTRAL doses per day.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of ABSTRAL. 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 (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. ABSTRAL 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. ABSTRAL contains the opioid fentanyl (as citrate) and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed ABSTRAL at recommended doses. Repeated use of ABSTRAL may lead to opioid use disorder. Accidental ingestion or exposure of ABSTRAL, especially by children, can result in a fatal overdose of fentanyl.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Non opioid-tolerant patients because of the risk of life-threatening respiratory depression. Severe respiratory disease, severe obstructive lung conditions, acute respiratory disease and respiratory depression. Use in patients not receiving opioid maintenance therapy for cancer-related pain. Use in patients for non-breakthrough cancer pain. Use in patients for acute and chronic non-cancer pain.

PBS listing

ABSTRAL sublingual tablets are listed on the PBS in strengths of 100, 200, 300, 400, 600, and 800 micrograms, with each strength available as 2 PBS items. All strengths are restricted to authority required prescriptions. The ex-manufacturer price for the 100, 300, and 400 microgram strengths is A$58.48 per unit, whilst the 200, 600, and 800 microgram strengths are priced at A$175.44 per unit.

Regulatory history

ABSTRAL was first registered on the ARTG on 22 August 2013 with the 100, 200, and 400 microgram strengths, followed by the 300, 600, and 800 microgram strengths on 27 July 2015. The TGA approved the registration of ABSTRAL sublingual tablets (100, 200, and 400 µg) on 12 August 2013 for the management of breakthrough pain in adult cancer patients already receiving maintenance opioid therapy.