SUGAMMADEX LUPIN

What it is

Sugammadex sodium is the active substance in this medicine. Sugammadex is available as a 200 mg/2 mL solution for injection vial and a 500 mg/5 mL solution for injection vial. The solution for injection is a clear and colourless to slightly brown solution. Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. 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, resulting in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

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. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. 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, and treatment with anti-cholinergic agents such as atropine should be administered if clinically significant bradycardia is observed. Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and healthy volunteers, and in clinical trials of surgical patients, these reactions were reported uncommonly. Symptoms associated with these reactions can include flushing, urticaria, erythematous rash, severe hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events. Severe hypersensitivity reactions can be fatal. An incidence of 0.2% for recurrence of neuromuscular blockade was observed in clinical studies, and 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. 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 and therefore ventilatory support might still be required.

Contraindications

Hypersensitivity to the active substance or to any of the excipients is a contraindication.

PBS listing

PBS listing information is not provided in the available source documents.

Regulatory history

Sugammadex Lupin 200 mg/2 mL solution for injection vial and 500 mg/5 mL solution for injection vial were first listed on the Australian Register of Therapeutic Goods on 1–2 November 2023.