SUGAMMADEX SANDOZ SOLUTION FOR INJECTION 100MG / ML

4.1 Therapeutic indications

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Sugammadex should only be administered by, or under the supervision of an anesthetist. 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 anesthetic regimen.

Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:

Adults

Routine reversal:

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Immediate reversal of rocuronium-induced blockade:

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.

Re-administration of sugammadex:

In the exceptional situation of recurrence of neuromuscular blockade post-operatively (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) 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.

Re-administration of rocuronium or vecuronium after sugammadex:

For waiting times for re-administration of rocuronium or vecuronium after reversal with sugammadex, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Additional information on special population

Renal impairment:

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.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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. – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Elderly patients:

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Obese patients:

In obese patients, including morbidly obese patients, the dose of sugammadex should be based on actual body weight. The same dose recommendations as for adults should be followed.

Hepatic impairment:

For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric population:

Children and adolescents (2 years and older):

Sugammadex Sandoz 100 mg/ml may be diluted to 10 mg/ml to increase the accuracy of dosing in the pediatric population (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Routine reversal:

A dose of 4 mg/kg sugammadex is recommended for reversal of rocuronium or vecuronium induced blockade if recovery has reached at least 1–2 post-tetanic counts (PTC).

A dose of 2 mg/kg is recommended for reversal of rocuronium or vecuronium induced blockade at reappearance of T2 (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Immediate reversal:

Immediate reversal in children and adolescents has not been investigated.

Term newborn infants and infants:

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.

Method of administration

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Sugammadex has only been administered as a single bolus injection in clinical trials.