Bridion Adverse Reactions

The safety of sugammadex has been evaluated in 3519 unique subjects across the Pooled Phase I-III safety database.
In the subject of Pooled Placebo-controlled trials where subjects received anesthesia and/or neuromuscular blocking agents (1078 subject exposures to sugammadex versus 544 to placebo), the following adverse events occurred in ≥2% of subjects treated with sugammadex and at least twice as often compared to placebo: (See Table 8.)

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In clinical studies, the investigator reported terms for complications resulting from anesthesia or surgery were grouped in the adverse event categories as follows, and included the following: Airway Complication of Anesthesia: Airway complications of anesthesia included bucking against the endotracheal tube, coughing, mild bucking, arousal reaction during surgery, coughing during the anesthetic procedure or during surgery, or contra breath (spontaneous breath of patient, anesthetic procedure related).
Anesthetic complication: Anesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube. (See Light anesthesia under Precautions.)
Recurrence of neuromuscular blockade: In clinical studies with subjects treated with rocuronium or vecuronium, where sugammadex was administered using a dose labeled for the depth of neuromuscular blockade (N=2022), an incidence of 0.20% was observed for recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence (see Precautions).
Procedural Complication: Procedural complications included coughing, tachycardia, bradycardia, movement, and increase in heart rate.
Description of selected adverse reactions: Drug hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers. (for information on volunteers, see Information on healthy volunteers as follows). In clinical trials of surgical patients, these reactions were reported uncommonly and for post-marketing reports the frequency is unknown.
These reactions 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.
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.
Information on healthy volunteers: A randomized, double-blind study examined the incidence of drug hypersensitivity reactions in healthy volunteers given up to 3 repeat doses of placebo (N=76), sugammadex 4 mg/kg (N=151) or sugammadex 16 mg/kg (N=148). Reports of suspected hypersensitivity were adjudicated by a blinded committee. The incidence of adjudicated hypersensitivity was 1.3%, 6.6% and 9.5% in the placebo, sugammadex 4 mg/kg and sugammadex 16 mg/kg groups, respectively. There were no reports of anaphylaxis after placebo or sugammadex 4 mg/kg.
There was a single case of adjudicated anaphylaxis after the first dose of sugammadex 16 mg/kg (incidence 0.7%). There was no evidence of increased frequency or severity of hypersensitivity with repeat dosing of sugammadex.
In a previous study of similar design, there were three adjudicated cases of anaphylaxis, all after sugammadex 16 mg/kg (incidence 2.0%).
The most common adverse reaction in pooled healthy volunteers was dysgeusia (10%).
Marked bradycardia: In post-marketing, isolated cases of marked bradycardia and bradycardia with cardiac arrest have been observed within minutes after administration of sugammadex (see Precautions).
Additional information on special populations: Pulmonary patients: In post-marketing data and in one dedicated clinical trial in patients with a history of pulmonary complications bronchospasm was reported as a possibly related adverse event. As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
Pediatric population: A limited database suggests that the safety profile of sugammadex (up to 4 mg/kg) in pediatric patients was similar to that in adults.
Morbidly obese patients: In one dedicated clinical trial in morbidly obese patients, the adverse reaction profile was generally similar to the profile in adult patients in pooled Phase 1 to 3 studies (see Table 8).
Patients with severe systemic disease: In a trial in patients who were assessed as American Society of Anesthesiologists (ASA) Class 3 or 4 (patients with severe systemic disease or patients with severe systemic disease that is a constant threat to life), the adverse reaction profile in these ASA Class 3 and 4 patients was generally similar to that of adult patients in pooled Phase 1 to 3 studies (see Table 8). See Pharmacology: Pharmacodynamics under Actions.