Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.
Sugammadex should only be administered by, or under the supervision of an anaesthetist.
The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade (see section 4.4).
The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
The recommended dose does not depend on the anaesthetic regimen.
Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade.
A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/T1 ratio to 0.9 of rocuronium when compared to vecuronium induced neuromuscular blockade (see section 5.1).
If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended. When 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 minutes can be expected (see section 5.1).
There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
In the exceptional situation of recurrence of neuromuscular blockade post-operatively (see section 4.4) after an initial dose of 2 mg/kg or 4 mg/kg sugammadex, a repeat dose of 4 mg/kg sugammadex is recommended. Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
For waiting times for re-administration of rocuronium or vecuronium after reversal with sugammadex, see section 4.4.
The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrCl <30 mL/min)) is not recommended (see section 4.4). Studies in patients with severe renal impairment do not provide sufficient safety information to support the use of sugammadex in these patients (see also section 5.1).
For mild and moderate renal impairment (creatinine clearance ≥30 and <80 mL/min): the dose recommendations are the same as for adults without renal impairment.
After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18-64 years) was 2.2 minutes, in elderly adults (65-74 years) it was 2.6 minutes and in very elderly adults (75 years or more) it was 3.6 minutes. Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see section 4.4).
In obese patients, including morbidly obese patients (body mass index ≥40 kg/m²), the dose of sugammadex should be based on actual body weight. The same dose recommendations as for adults should be followed.
Studies in patients with hepatic impairment have not been conducted. Caution should be exercised when considering the use of sugammadex in patients with severe hepatic impairment or when hepatic impairment is accompanied by coagulopathy (see section 4.4).
For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.
Bridion 100 mg/mL may be diluted to 10 mg/mL to increase the accuracy of dosing in the paediatric population (see section 6.6).
Routine reversal:
A dose of 4 mg/kg sugammadex is recommended for reversal of rocuronium induced blockade if recovery has reached at least 1-2 PTC.
A dose of 2 mg/kg is recommended for reversal of rocuronium induced blockade at reappearance of T2 (see section 5.1).
Immediate reversal:
Immediate reversal in children and adolescents has not been investigated.
There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied. The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
Sugammadex should be administered intravenously as a single bolus injection. The bolus injection should be given rapidly, within 10 seconds, into an existing intravenous line (see section 6.6). Sugammadex has only been administered as a single bolus injection in clinical trials.
In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant adverse reactions. In a human tolerance study sugammadex was administered in doses up to 96 mg/kg. No dose related adverse events nor serious adverse events were reported.
Sugammadex can be removed using haemodialysis with a high flux filter, but not with a low flux filter. Based upon clinical studies, sugammadex concentrations in plasma are reduced by up to 70% after a 3 to 6-hour dialysis session.
3 years.
After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Store below 30°C.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.
2 mL or 5 mL of solution in type I glass vial closed with chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal.
Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Not all pack-sizes may be marketed.
Bridion can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%), Ringers lactate solution, Ringers solution, glucose 50 mg/mL (5%) in sodium chloride 9 mg/mL (0.9%).
The infusion line should be adequately flushed (e.g. with 0.9% sodium chloride) between administration of Bridion and other drugs.
For paediatric patients Bridion can be diluted using sodium chloride 9 mg/mL (0.9%) to a concentration of 10 mg/mL (see section 6.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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