TEMGESIC

What it is

TEMGESIC is available as an injection and sublingual tablets containing buprenorphine (as hydrochloride). The injection contains 300 micrograms of buprenorphine per 1 mL. Each sublingual tablet contains 200 micrograms of buprenorphine (as hydrochloride). Buprenorphine is a μ-opioid partial agonist with high affinity for the μ-opioid receptor, demonstrating both agonist and antagonist properties.

Approved indications —

Short-term (not more than one week) management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. TEMGESIC Injection should be employed when sublingual administration is not practical, such as pre- or peri-operatively.

Dosing overview

For TEMGESIC Injection, the recommended dosage is 300–600 micrograms by intramuscular or slow intravenous injection, repeated every 6–8 hours, or as required. For TEMGESIC Sublingual Tablets, the usual recommended dose is 1 to 2 tablets (200–400 micrograms of buprenorphine) dissolved under the tongue every 6–8 hours, or as required. Tablets should be kept in place for 10 minutes without swallowing.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of TEMGESIC. Clinicians 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. Naloxone may not be effective in reversing the respiratory depression produced by TEMGESIC. Therefore, the primary management of overdose should be the re-establishment of adequate ventilation with mechanical assistance of respiration, if required. 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. Dosages must be limited and durations minimised; patients should be monitored for signs and symptoms of respiratory depression and sedation. Patients should be cautioned not to drink alcohol while taking TEMGESIC. TEMGESIC poses risks of hazardous and harmful use which can lead to overdose and death. Clinicians should assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment. TEMGESIC contains the opioid buprenorphine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed TEMGESIC at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness.

Contraindications

TEMGESIC is contraindicated in pregnancy and lactation. TEMGESIC should not be administered to patients who have been shown to be hypersensitive to buprenorphine or other opioids. TEMGESIC is contraindicated for use in patients with severe respiratory disease, acute respiratory disease and respiratory depression.

Regulatory history

TEMGESIC injection (buprenorphine 300 microgram/1 mL) was first listed on the ARTG on 30 September 1991. TEMGESIC sublingual tablets (buprenorphine 200 microgram) in blister pack form were first listed on the ARTG on 22 July 1992. TEMGESIC sublingual tablets in bottle form were first listed on the ARTG on 16 May 2008.