SUGAMMADEX ARX

What it is

Sugammadex Medsurge is a solution for injection containing sugammadex as the sodium salt. The solution for injection contains sugammadex 100 mg/mL. The solution is clear and colourless to slightly yellow, with pH between 7 and 8 and osmolality between 300 and 500 mOsm/kg. Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent (SRBA). It 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. For routine reversal in adults, 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. For immediate reversal following a clinical need after rocuronium administration, a dose of 16.0 mg/kg sugammadex is recommended. For children and adolescents aged 2 years and older, a dose of 4 mg/kg sugammadex is recommended for routine reversal of rocuronium- or vecuronium-induced blockade if recovery has reached at least 1–2 post-tetanic counts (PTC). A dose of 2 mg/kg is recommended for reversal of rocuronium or vecuronium-induced blockade at reappearance of T2. 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. Even if recovery from neuromuscular blockade is complete, other drugs used in the peri- and postoperative period could depress respiratory function and therefore ventilatory support might still be required. In clinical studies where sugammadex was administered using a dose labelled for the depth of neuromuscular blockade, an incidence of 0.2% was observed for recurrence of neuromuscular blockade. The use of lower than recommended doses may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended. In rare instances, marked bradycardia has been observed within minutes after administration of sugammadex for reversal of neuromuscular blockade. Patients should be closely monitored for haemodynamic changes during and after reversal of neuromuscular blockade. 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. The risk of drug hypersensitivity reactions appears to be dose-dependent.

Contraindications

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

PBS listing

No source document contains information about PBS listing for SUGAMMADEX ARX.

Regulatory history

SUGAMMADEX ARX 500 mg/5 mL solution for injection vial was first listed on the ARTG on 8 June 2022. SUGAMMADEX ARX 200 mg/2 mL solution for injection vial was also first listed on the ARTG on 8 June 2022.