Remifentanil-AFT

What it is

Remifentanil-AFT is a powder for injection containing remifentanil (as hydrochloride) in strengths of 1 mg, 2 mg or 5 mg per vial. It is a sterile, endotoxin free, non-pyrogenic, preservative-free, white to off-white lyophilised powder for intravenous injection or infusion.

Approved indications —

As an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults — As an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years — For continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery when endotracheal intubation and controlled ventilation are anticipated — For provision of analgesia and sedation in mechanically ventilated intensive care patients

Dosing overview

For induction of anaesthesia in adults, a slow bolus injection of 1 microgram/kg administered over 60 seconds, or a continuous infusion starting at 0.5 to 1 microgram/kg/min. For maintenance of anaesthesia with nitrous oxide, isoflurane or propofol, a continuous infusion with starting rate and range varying by agent used. For maintenance of anaesthesia in children aged 1 to 12 years, a bolus injection of 1 microgram/kg administered over not less than 30 seconds is optional, with a continuous infusion starting at 0.25 microgram/kg/min and typical maintenance rates of 0.05 to 1.3 microgram/kg/min depending on the concomitant anaesthetic agent. For cardiac anaesthesia in adults, bolus injection is not recommended during intubation, with a starting infusion rate of 1 microgram/kg/min for induction and typical infusion rates of 0.003 to 4.3 microgram/kg/min for maintenance depending on the agent used. For intensive care patients, an initial infusion rate of 0.1 to 0.15 microgram/kg/min, titrated in increments of 0.025 microgram/kg/min to achieve the desired level of analgesia and sedation.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of Remifentanil-AFT. 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. Caution patients not to drink alcohol while taking Remifentanil-AFT. At the recommended doses, Remifentanil-AFT can cause muscle rigidity. Profound chest wall rigidity and inability to ventilate the patient has occurred during induction and following inadvertent boluses after intravenous line flushing. The incidence of muscle rigidity is related to the dose and rate of administration. Therefore, boluses should be administered slowly, over 60 seconds. Remifentanil-AFT causes dose-dependent hypotension and bradycardia. These effects may be attenuated by the pre-administration of an appropriate anticholinergic agent such as glycopyrronium bromide or atropine. Because of the risks associated with the use of opioids, Remifentanil-AFT 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. Remifentanil-AFT 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.

Contraindications

Remifentanil-AFT is not suitable as the sole agent for induction of general anaesthesia. It is not recommended for use in spontaneous ventilation anaesthesia or as an analgesic in the immediate post-operative period due to inadequate safety data in such uses, except in ventilated cardiac surgery patients. As glycine is present in the formulation, Remifentanil-AFT is contraindicated for epidural and intrathecal use. Remifentanil-AFT is contraindicated for use in patients with severe respiratory disease, acute respiratory disease and respiratory depression. Remifentanil-AFT is contraindicated for use in chronic (long-term) non-cancer pain. Remifentanil-AFT is contraindicated in patients with known hypersensitivity to any component of the preparation and to other fentanyl analogues.

Regulatory history

Remifentanil-AFT was first listed on the ARTG on 20 March 2013 across three strengths: 1 mg, 2 mg and 5 mg powder for injection in glass vials.