Presentation and Status in Health Basket
| Presentation | Basket | Yarpa | Pharmasoft |
|---|---|---|---|
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Solution for Injection 2 ml X 100 mg/ml |
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2541 | |
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Solution for Injection 5 ml X 100 mg/ml |
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2542 |
Dosage
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.
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.
See prescribing information for full details.
Indications
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Contra-Indications
Hypersensitivity to the active substance or to any of the excipients.
Patients with severe renal impairment (including patients requiring dialysis (CrCl< 30 ml/min)).
Patients with severe hepatic impairment.
Special Precautions
Should only be administered by, or under the supervision of an anesthetist. The recommended dose depends on the level of neuromuscular blockade to be reversed.
See prescribing information for full details.
Side Effects
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.
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.
Drug interactions
No interaction studies have been conducted in adults with sugammadex and other medicinal products. The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the
pharmacokinetic interaction between neuromuscular blocking agents and sugammadex. Based on in-vitro data and taking into consideration pharmacokinetics and other relevant information, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following: For toremifene, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected). Interactions potentially affecting the efficacy of sugammadex:
Toremifene: For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur. The recovery of the T4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.
Intravenous administration of flucloxacillin and fusidic acid: Intravenous administration of fusidic acid and high dose flucloxacillin (infusion of 500 mg or more), may cause some displacement of rocuronium or vecuronium from sugammadex. The use of these medicinal products in the pre-operative phase may give some delay in the recovery of the T4/T1 ratio to 0.9. The use of these medicinal products in the post-operative phase after routine reversal during the surveillance period of 6 hours should be avoided. If administration of flucloxacillin or fusidic acid within this time period can not
be avoided, ventilation should be closely observed, in particular during the first 15 minutes after dosing. For re-administration of sugammadex.
Interactions potentially affecting the efficacy of other medicinal products:
Hormonal contraceptives: The interaction between 4 mg/kg sugammadex and a progestogen was predicted to lead to a
decrease in progestogen exposure (34 % of AUC) similar to the decrease seen when a daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness. For estrogens, the effect is expected to be lower. Therefore the administration of a bolus dose of sugammadex is considered to be equivalent to one missed daily dose of oral contraceptive steroids (either combined or progestogen only). If sugammadex is administered at the same day as an oral contraceptive is taken reference is made to missed dose advice in the package leaflet of the oral contraceptive. In the case of non-oral hormonal
contraceptives, the patient must use an additional non hormonal contraceptive method for the next 7 days and refer to the advice in the package leaflet of the product.
Interference with laboratory tests: In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay. Interference with this test is observed at sugammadex plasma concentrations of 100 μg/m.
See prescribing information for full details.
Pregnancy and Lactation
For sugammadex no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Caution should be exercised when administering sugammadex to pregnant women. It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown excretion of sugammadex in breast milk. Oral absorption of cyclodextrins in general is low and no effects on the suckling child is anticipated following a single dose to the breast-feeding woman. Sugammadex can be used during breast-feeding.
Overdose
In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant undesirable effects. 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 with a high-flux filter by about 70% after a 3 to 6-hour dialysis session.
