ACCODEX SOLUTION FOR INJECTION 100MG/ML [SIN16994P]

Product Info

ACCODEX SOLUTION FOR INJECTION 100MG/ML

[SIN16994P]

4.1 THERAPEUTIC INDICATIONS

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

4.2 DOSE 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 anaesthetic regimen.

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

Adults

Routine reversal

A dose of 4.0 mg/kg sugammadex is recommended if recovery has reached 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 Pharmacodynamic Properties, Clinical trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

A dose of 2.0 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to 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 Pharmacodynamic Properties, Clinical trials – 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-induced blockade, when compared to vecuronium-induced neuromuscular blockade (see Section 5.1 Pharmacodynamic Properties, Clinical trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Immediate reversal

If there is a clinical need for immediate reversal following administration of rocuronium, a dose of 16.0 mg/kg sugammadex is recommended. Administration of 16.0 mg/kg sugammadex 3 minutes following a bolus dose of 1.2 mg/kg rocuronium bromide provides a median time to recovery of the T₄/T₁ ratio to 0.9 of approximately 1.5 minutes (see Section 5.1 Pharmacodynamic Properties, Clinical trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

There are 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.

Paediatric population

Children and adolescents (2 years and older)

Sugammadex 100 mg/mL may be diluted to 10 mg/mL to increase the accuracy of dosing in the paediatric population (see Method of administration).

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

Immediate reversal

The use of higher doses (as for immediate reversal) in children and adolescents has not been investigated and is therefore not recommended.

Neonates and infants

There is only limited experience with infants (30 days to 2 years); neonates (less than 30 days) have not been studied. Therefore the use of sugammadex in neonates and infants is not recommended until further data become available.

Special populations

Renal impairment

The dose recommendations for mild and moderate renal impairment (creatinine clearance between 30 and 80 mL/min) are the same as for adults without renal impairment. For re-administration with rocuronium or vecuronium (see Section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) for waiting times.

Sugammadex is not recommended for use in patients with severe renal impairment (including patients requiring dialyses) (see Section 4.4 Special Warnings and Precautions for Use – 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 Section 5.1 Pharmacodynamic Properties, Clinical trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 Special Warnings and Precautions for Use – 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) it was 3.6 minutes. Even though the recovery time in elderly tends to be slower, the same dose recommendation as for adults should be followed (see Section 4.4 Special Warnings and Precautions for Use – 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 recommendation as for adults should be followed.

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 IV line. Sugammadex has only been administered as a single bolus injection in clinical trials.

Compatibility

Sugammadex can be injected into the intravenous line of a running infusion with the following intravenous solutions: 0.9% sodium chloride; 5% glucose, Gelofusine; 0.45% sodium chloride and 2.5% glucose; Ringers lactate solution; Ringers solution; Lactec; Lactec D and G; Hespander; Veen-F; Physio 140; 5% glucose in 0.9% sodium chloride; and isolyte P with 5% glucose.

The infusion line should be adequately flushed (e.g., with 0.9% sodium chloride) between administration of sugammadex and other drugs.

For paediatric patients, Sugammadex can be diluted using 0.9% sodium chloride to a concentration of 10 mg/mL.

After dilution with infusion fluids, to reduce microbiological hazard, the diluted solution should be used as soon as practical. If storage of the diluted solution is necessary, solutions should be stored at room temperature (below 25°C) for no more than 6 hours or under refrigeration at 2°C to 8°C for no more than 24 hours.

The product contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.

Waiting times for re-administration with neuromuscular blocking agents after reversal with sugammadex

If re-administration of rocuronium or vecuronium is required after reversal with sugammadex (up to 4 mg/kg), the following waiting times are recommended (see Table 1).

Based on PK modelling the recommended waiting time in patients with mild or moderate renal impairment for re-use of 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium after routine reversal with sugammadex should be 24 hours. If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg.

When rocuronium 1.2 mg/kg is administered within 30 minutes after reversal with sugammadex, the onset of neuromuscular blockade may be delayed up to approximately 4 minutes and the duration of neuromuscular blockade may be shortened up to approximately 15 minutes.

Re-administration of rocuronium or vecuronium after immediate reversal (16 mg/kg sugammadex): For the very rare cases where this might be required, a waiting time of 24 hours is suggested.

If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used. The onset of a depolarizing neuromuscular blocking agent might be slower than expected, because a substantial fraction of postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.

4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.