SUGAMMADEX KABI

What it is

Sugammadex Kabi is a solution for injection containing sugammadex 100 mg/mL. Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent (SRBA) that forms a complex with the neuromuscular blocking agents rocuronium or vecuronium and reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction.

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 and does not depend on the anaesthetic regimen. A dose of 4.0 mg/kg sugammadex is recommended if recovery has reached 1–2 post-tetanic counts (PTC) following rocuronium- or vecuronium-induced blockade. A dose of 2.0 mg/kg sugammadex is recommended if spontaneous recovery has occurred up to the reappearance of T2 following rocuronium- or vecuronium-induced blockade. If there is a clinical need for immediate reversal following administration of rocuronium, a dose of 16.0 mg/kg sugammadex is recommended. For children and adolescents 2 years and older, a dose of 4 mg/kg is recommended for routine reversal, and a dose of 2 mg/kg is recommended at reappearance of T2; the use of higher doses for immediate reversal in children and adolescents has not been investigated and is therefore not recommended. Sugammadex should be administered intravenously as a single bolus injection, given rapidly within 10 seconds into an existing IV line.

Key safety warnings

Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular blockade, and even if recovery from neuromuscular blockade is complete, other drugs used in the peri- and post-operative period could depress respiratory function. In rare instances, marked bradycardia has been observed within minutes after administration of sugammadex for reversal of neuromuscular blockade, and patients should be closely monitored for haemodynamic changes during and after reversal; 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) and take the necessary precautions, as the risk appears to be dose-dependent. Since bleeding risk has not been studied systematically at higher doses than sugammadex 4 mg/kg, coagulation parameters should be carefully monitored in patients using anticoagulants who receive a dose of 16 mg/kg sugammadex.

Contraindications

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

PBS listing

Information regarding PBS listing is not available in the provided source documents.

Regulatory history

Sugammadex Kabi was first listed on the ARTG on 24 January 2024 with two registered variants: a 500 mg/5 mL solution for injection vial (ARTG 405170) and a 200 mg/2 mL solution for injection vial (ARTG 405171).