SUGAMMADEX-AFT

What it is

Sugammadex-AFT is a solution for injection available in two strengths: 200 mg in 2 mL and 500 mg in 5 mL. The solution is clear and colourless to slightly yellow. Sugammadex is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agents rocuronium or vecuronium, reducing the amount available to bind to nicotinic receptors in the neuromuscular junction, thereby reversing neuromuscular blockade.

Approved indications

— Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.

Dosing overview

The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed. For routine reversal in adults, a dose of 4.0 mg/kg is recommended if recovery has reached 1–2 post-tetanic counts, with median recovery time of approximately 3 minutes, or 2.0 mg/kg if spontaneous recovery has occurred up to reappearance of T2, with median recovery time of approximately 2 minutes. For immediate reversal following rocuronium administration, 16.0 mg/kg sugammadex is recommended, providing median recovery time of approximately 1.5 minutes. In children aged 2 years and older, routine reversal uses 4 mg/kg for blockade at 1–2 post-tetanic counts or 2 mg/kg at reappearance of T2. The use of higher doses for immediate reversal in children and adolescents has not been investigated and is not recommended.

Key safety warnings

Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular blockade, and other drugs used in the perioperative period could depress respiratory function. Recurrence of neuromuscular blockade occurred in 0.2% of subjects treated with the recommended dose; lower than recommended doses may lead to increased risk of recurrence. Doses of 4 mg/kg and 16 mg/kg resulted in maximum mean prolongations of activated partial thromboplastin time by 17% and 22% respectively and prothrombin time international normalised ratio by 11% and 22% respectively, with these prolongations of short duration (≤30 minutes). In patients with known coagulopathies, activated partial thromboplastin time, prothrombin time and prothrombin time international normalised ratio should be monitored after administration of sugammadex. Marked bradycardia has been observed within minutes after administration of sugammadex, with isolated cases of bradycardia with cardiac arrest reported; patients should be closely monitored for haemodynamic changes and treatment with anti-cholinergic agents such as atropine should be administered if clinically significant bradycardia is observed. Clinicians should be prepared for the possibility of drug hypersensitivity reactions including anaphylactic reactions, with risk appearing to be dose-dependent. Hypersensitivity reactions including anaphylaxis have occurred in patients and healthy volunteers, reported uncommonly in clinical trials of surgical patients.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

Sugammadex-AFT 200 mg/2 mL (ARTG 462701) and 500 mg/5 mL (ARTG 462702) were first listed on the Australian Register of Therapeutic Goods on 26 November 2025.