Rufinamide

Generic name
Rufinamide
Brand name
ATC Code
N03AF03
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Rufinamide

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Children generally have a lower rufinamide clearance than adults, a difference that is related to body size.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Adjuvant treatment for episodes in Lennox-Gastaut syndrome: WITHOUT VALPROATE
  • Oral
    • 1 year up to 4 years
      • Initial dose: 10 mg/kg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every third day depending on the clinical response and tolerance, in steps of at most 10 mg/kg/day up to 10 - 45 mg/kg/day in 2 doses. Max: 45 mg/kg/day.
    • ≥ 4 years and < 30 kg
      • Initial dose: 200 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every third day depending on the clinical response and tolerance, in steps of 200 mg/day up to 200 - 1.000 mg/day in 2 doses. Max: 1.000 mg/day.

      • Doses of up to a maximum of 3600 mg/day have been studied in a limited number of patients.

    • ≥ 4 years and 30 up to 50 kg
      • Initial dose: 400 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every other day depending on the clinical response and tolerance, in steps of 400 mg/day up to   400 - 1.800 mg/day in 2 doses. Max: 1.800 mg/day.

      • Higher doses – up to a maximum of 4000 mg/day – have been studied in a limited number of patients. 

    • ≥ 4 years and 50 up to 70 kg
      • Initial dose: 400 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every other day depending on the clinical response and tolerance, in steps of 400 mg/day up to   400 - 2.400 mg/day in 2 doses. Max: 2.400 mg/day.

      • Higher doses – up to a maximum of 4800 mg/day – have been studied in a limited number of patients. 

    • ≥ 4 years and ≥ 70 kg
      • Initial dose: 400 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every other day depending on the clinical response and tolerance, in steps of 400 mg/day up to 400 - 3.200 mg/day in 2 doses. Max: 3.200 mg/day.

      • Higher doses – up to a maximum of 4800 mg/day – have been studied in a limited number of patients. 
Adjuvant treatment for episodes in Lennox-Gastaut syndrome: IN COMBINATION WITH VALPROATE
  • Oral
    • 1 year up to 4 years
      • Initial dose: 10 mg/kg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every third day depending on the clinical response and tolerance, in steps of at most 10 mg/kg/day up to 10 - 30 mg/kg/day in 2 doses. Max: 30 mg/kg/day.
    • ≥ 4 years and < 30 kg
      • Initial dose: 200 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose after a minum of 2 days  depending on the clinical response and tolerance, by 200 mg/day to 200 - 600 mg/day in 2 doses.
    • ≥ 4 years and 30 up to 50 kg
      • Initial dose: 400 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every other day depending on the clinical response and tolerance, in steps of 400 mg/day up to   400 - 1.200 mg/day in 2 doses. Max: 1.200 mg/day.
    • ≥ 4 years and 50 up to 70 kg
      • Initial dose: 400 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every other day depending on the clinical response and tolerance, in steps of 400 mg/day up to   400 - 1.600 mg/day in 2 doses. Max: 1.600 mg/day.
    • ≥ 4 years and ≥ 70 kg
      • Initial dose: 400 mg/day in 2 doses.
      • Maintenance dose: Increase the starting dose every other day depending on the clinical response and tolerance, in steps of 400 mg/day up to 400 - 2.200 mg/day in 2 doses. Max: 2.200 mg/day.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Paediatric Population (age 1 to less than 4 years):

Very common (≥ 10%): upper respiratory tract infection, vomiting, pneumonia, somnolence, sinusitis, otitis media, diarrhoea, cough, pyrexia, bronchitis, constipation, nasal congestion, rash, irritability and decreased appetite

The frequency, type and severity of these adverse reactions were similar to that in children 4 years of age and older, adolescents and adults. [SmPC Inovelon]

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIEPILEPTICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Barbiturates and derivatives
N03AA02
N03AA03
Hydantoin derivatives
N03AB02
Succinimide derivatives
N03AD01
Benzodiazepine derivatives
N03AE01
Carboxamide derivatives
N03AF01
N03AF02
Fatty acid derivatives
N03AG01
N03AG04
Other antiepileptics
N03AX23
N03AX24
N03AX10
N03AX26
N03AX18
N03AX09
N03AX14
N03AX22
N03AX16
N03AX17
N03AX03
N03AX11
N03AX15

Reference

  1. Eisai Limited, SPC Inovelon (EU/1/06/378/017) Rev 22, 17-08-2021, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose