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

Interactions
PK
Renal impairment
References

Perampanel

Generic name
Perampanel
Brand name
ATC Code
N03AX22

Pharmacokinetics in children

The kinetics in adolescents aged 12 years and up are comparable to the kinetics in adults.

The following pharmacokinetic parameters were found in the absence of anti-epileptics that affect the kinetics of perampanel (Renfroe 2019):

Age n= Cl/F (L/hour)
12-17 years 79 0.7±0.4
7-11 years 12 1.0±0.4
2-6 years 14 0.7±0.4

In combination with enzyme-inducing anti-epileptics (carbamazepine, oxcarbazepine and phenytoin) the following values were found (Renfroe 2019):

Age n= Cl/F (L/hour)
12-17 years 73 1.6±0.8
7-11 years 10 1.9±0.5
2-6 years 6 1.7±1.2

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Epilepsy
  • Oral
    • 4 years up to 18 years and ≥ 30 kg
      • Initial dose: 2 mg/day in 1 dose
      • Maintenance dose: Depending on the clinical response, increase the starting dose every 1–2 weeks by steps of 2 mg (depending on combined use with other CYP3A4 inducing drugs) to 4 - 8 mg/day in 1 dose If necessary, further increases can be made in increments of 2 mg every 1-2 weeks to a maximum of 12 mg/day.
      • Directions for administration:

        Administer in the evening before going to bed.

    • 4 years up to 18 years and < 20 kg
      • Initial dose: 1 mg/day in 1 dose
      • Maintenance dose: Depending on the clinical response, increase the starting dose every 1–2 weeks by steps of 1 mg (depending on combined use with other CYP3A4 inducing drugs) to 2 - 4 mg/day in 1 dose If necessary, further increases can be made in increments of 0.5 mg every 1-2 weeks to a maximum of 6 mg/day.
      • Directions for administration:

        Administer in evening before going to bed

    • 1 year up to 4 years
      • Initial dose: 0.015 mg/kg/day in 1 dose
      • Maintenance dose: Depending on the clinical response, increase the starting dose to lowest maintenance dose and subsequently every 1–2 weeks by steps of 0.03 mg/kg (depending on combined use with other CYP3A4 inducing drugs) to 0.03 - 0.15 mg/kg/day in 1 dose. Max: 6 mg/day.
      • Directions for administration:

        Administer in evening before going to sleep

    • 4 years up to 18 years and 20 up to 30 kg
      • Initial dose: 1 mg/day in 1 dose
      • Maintenance dose: Depending on the clinical response, increase the starting dose every 1–2 weeks by steps of 1 mg (depending on combined use with other CYP3A4 inducing drugs) to 4 - 6 mg/day in 1 dose If necessary, further increases can be made in increments of 1 mg every 1-2 weeks to a maximum of 8 mg/day.
      • Directions for administration:

        Administer in evening before going to bed

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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.

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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

Drowsiness, irritability, aggression and agitation have been observed more frequently in children than in adolescents and adults.

Aggression was observed more frequently in adolescents than in adults.

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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.

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Interactions

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

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Barbiturates and derivatives
N03AA02
N03AA03
Hydantoin derivatives
N03AB02
Succinimide derivatives
N03AD01
Benzodiazepine derivatives
N03AE01
Carboxamide derivatives
N03AF01
N03AF02
N03AF03
Fatty acid derivatives
N03AG01
N03AG04
Other antiepileptics
N03AX23
N03AX24
N03AX10
N03AX26
N03AX18
N03AX09
N03AX14
N03AX16
N03AX17
N03AX03
N03AX11
N03AX15

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References

  1. Eisai Europe Limited, SmPC Fycompa (EU/1/12/776/024) Rev 32.10-05-2023, www.ema.europa.eu
  2. Swiderska, N. et al., Effectiveness and tolerability of Perampanel in children, adolescents and young adults with refractory epilepsy: A UK national multicentre study., Seizure, 2017, 52, 63-70
  3. Renfroe, J. B. et al., Adjunctive Perampanel Oral Suspension in Pediatric Patients From >/=2 to <12 Years of Age With Epilepsy: Pharmacokinetics, Safety, Tolerability, and Efficacy, J Child Neurol, 2019, 34(5), 284-294
  4. Heyman, E. et al., Tolerability and efficacy of perampanel in children with refractory epilepsy., Dev Med Child Neurol, 2017, 59(4), 441-444
  5. De Liso, P. et al., Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies-An Italian observational multicenter study., Epilepsy Res, 2015, 127, 93-100
  6. Biro, A.et al., Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences, Neuropediatrics, 2015, 46(2), 110-6
  7. Auvin S. et al., Use of perampanel in children and adolescents with Lennox-Gastaut Syndrome, Epilepsy Behav, 2017, 74, 59-63
  8. Ishikawa, N. et al, Clinical profiles associated with serum perampanel concentrations in children with refractory epilepsy, Epilepsy Behav, 2019, 94, 82-6

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Changes

Changes