Sugammadex (1 brand name, 2 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, INJECTION.
Routes of administration: INJECTION, SOLUTION.
Brand Names
- SUGAMMADEX
Indications and Usage
Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.
Contraindications
Sugammadex injection 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 [see Warnings and Precautions (5.1), Adverse Reactions (6)].
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Anaphylaxis and Hypersensitivity [see Contraindications (4), Warnings and Precautions (5.1)] Marked Bradycardia [see Warnings and Precautions (5.2)]
Mechanism of Action
Sugammadex 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.
Overdosage
In premarketing clinical trials, one case of accidental overdose with 40 mg/kg sugammadex was reported without significant effects. Sugammadex can be removed using hemodialysis with a high-flux filter, but not with a low-flux filter. Based upon clinical studies, sugammadex concentrations in plasma are reduced with a high-flux filter by about 70% after a 3- to 6-hour dialysis session.