e; 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000)]
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 below). 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.
Anaesthetic complication:
Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube. See section 4.4 light anaesthesia.
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 section 4.4).
Awareness:
In sugammadex treated subjects a few cases of awareness were reported. The relation to sugammadex is uncertain.
Recurrence of neuromuscular blockade:
In the data-base of pooled phase I-III studies with a placebo group, the incidence of recurrence of neuromuscular blockade as measured with neuromuscular monitoring was 2% after sugammadex and 0% in the placebo group. Virtually all of these cases were from dose-finding studies in which a sub-optimal dose (less than 2 mg/kg) was administered (see section 4.4).
Information on healthy volunteers:
Hypersensitivity reactions, including anaphylaxis, have been observed with sugammadex. In a study in healthy conscious volunteers (placebo, N=150; 4 mg/kg, N=148; and 16 mg/kg, N=150), hypersensitivity reactions were reported commonly with sugammadex 16 mg/kg (n=7, 4.7%), uncommonly with sugammadex 4 mg/kg (n=1, 0.7%), and none with placebo (n=0, 0%).
In this study, dose dependent trends were also observed for dysgeusia, nausea and flushing.
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.
Paediatric population
A limited database suggests that the safety profile of sugammadex (up to 4 mg/kg) in paediatric patients was similar to that in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard.
4.9 Overdose
In clinical studies |
