SUGAMMADEX-TEVA

What it is

SUGAMMADEX-TEVA is a solution for injection containing sugammadex 100 mg/mL. Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent 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. Sugammadex should be administered intravenously as a single bolus injection, given rapidly within 10 seconds into an existing IV line.

Key safety warnings

In rare instances, marked bradycardia has been observed within minutes after administration of sugammadex for reversal of neuromuscular blockade, and isolated cases of bradycardia with cardiac arrest have been reported. 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. Doses of 4 mg/kg and 16 mg/kg of sugammadex resulted in maximum mean prolongations of activated partial thromboplastin time by 17 and 22 percent, and of prothrombin time international normalised ratio by 11 and 22 percent, respectively. These limited mean prolongations were of short duration of 30 minutes or less. 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. 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 PBS listing information is provided in the source documents.

Regulatory history

SUGAMMADEX-TEVA was registered on the ARTG on 28 March 2023 with two presentations: 200 mg/2 mL solution for injection vial and 500 mg/5 mL solution for injection vial.