Sugammadex

BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.

BRIDION is a modified gamma cyclodextrin. It forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium and vecuronium.

Dosing is based on actual body weight. Monitor for twitch responses to determine the timing and dose for BRIDION administration. Administer as a single bolus injection. For rocuronium and vecuronium: 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation. 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation. For rocuronium only: 16 mg/kg is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. Immediate reversal in pediatric patients has not been studied.

BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex. Known hypersensitivity to sugammadex or any of its components.

Anaphylaxis: Be prepared for hypersensitivity reactions (including anaphylactic reactions) and take necessary precautions. Marked Bradycardia: Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after administration. Monitor for hemodynamic changes and administer anticholinergic agents such as atropine if clinically significant bradycardia is observed. Respiratory Function Monitoring: Ventilatory support is mandatory until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Provide adequate ventilation if neuromuscular blockade persists after BRIDION or recurs following extubation.

The following serious adverse reactions are described elsewhere in the labeling: Anaphylaxis and Hypersensitivity Marked Bradycardia Most common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache. Most common adverse reactions (reported in ≥10% of pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg) were pain, vomiting, and nausea. Most common adverse reaction (reported in ≥10% of pediatric patients from birth to <2 years of age at BRIDION doses of 2 or 4 mg/kg) was procedural pain.

Toremifene: Concomitant use can delay recovery. Hormonal contraceptives: Patients must use an additional, non-hormonal method of contraception for 7 days following BRIDION administration.

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. When not protected from light, the vial should be used within 5 days.