Incidence of hypersensitivity and anaphylaxis with sugammadex

Abstract Study objective To evaluate the incidence of hypersensitivity and anaphylaxis after administration of sugammadex. Design Retrospective analysis. Setting Sugammadex clinical development program and post-marketing experience. Patients Surgical patients and healthy volunteers who received sugammadex or placebo/comparator with anesthesia and/or neuromuscular blockade (NMB). Interventions Sugammadex administered as 2.0 mg/kg at reappearance of the second twitch, 4.0 mg/kg at 1–2 post-tetanic count, or 16.0 mg/kg at 3 min after rocuronium 1.2 mg/kg. Measurements Three analytical methods were used: 1) automated MedDRA queries; 2) searches of adverse events (AEs) consistent with treatment-related hypersensitivity reactions as diagnosed by the investigator; and 3) a retrospective adjudication of AEs suggestive of hypersensitivity by a blinded, independent adjudication committee (AC). In addition, a search of all post-marketing reports of events of hypersensitivity was performed, and events were retrospectively adjudicated by an independent AC. Anaphylaxis was determined according to Sampson Criterion 1. Main results The pooled dataset included 3519 unique subjects who received sugammadex and 544 who received placebo. The automated MedDRA query method showed no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. Similarly, there was a low overall incidence of AEs of treatment-related hypersensitivity ( Conclusions Subjects who received sugammadex with general anesthesia and/or NMB had a low overall incidence of hypersensitivity, with no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine.