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

Interactions
PK
Renal impairment
References

(Fos)Aprepitant

Generic name
(Fos)Aprepitant
Brand name
ATC Code
A04AD12

Pharmacokinetics in children

The following kinetic parameters have been observed for aprepitant on day one of the registered dosing regimen (1 dose of 3 mg/kg, max 125 mg) (SPC of Emend suspension):

  n= Cmax Tmax
6 months to 11 years 105 1.2 µg/ml 5-7 hours
12-17 yrs 47 1.3 µg/ml 4 hours

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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

Prevention of nausea and vomiting in chemotherapy
  • Oral
    • 6 months up to 18 years and 6 up to 40 kg
      [1] [2]
      • Initial dose: Day 1: 1 hour before chemotherapy 3 mg/kg/dose, once only.
      • Maintenance dose: On days 2 and 3: 2 mg/kg/day in 1 dose  take in the morning..
    • 6 months up to 18 years and ≥ 40 kg
      [1] [2]
      • Initial dose: Day 1: 1 hour before chemotherapy 125 mg/dose, once only.
      • Maintenance dose: On days 2 and 3: 80 mg/day in 1 dose  take in the morning..
Prophylaxis for cyclic vomiting if treatment with other drugs has not proved sufficiently effective
  • Oral
    • 3 years up to 18 years and < 40 kg
      [3] [4]
      • twice a week 40 mg/dose spread over the week.
    • 3 years up to 18 years and 40 up to 60 kg
      [3] [4]
      • twice a week 80 mg/dose spread over the week.
    • 3 years up to 18 years and ≥ 60 kg
      [3] [4]
      • twice a week 125 mg/dose spread over the week.
Acute treatment of cyclic vomiting if treatment with other drugs has not proved sufficiently effective
  • Oral
    • 3 years up to 18 years and < 15 kg
      [3]

      • Day 1: 80 mg/day in a single dose
        Days 2 and 3: 40 mg/day in a single dose

    • 3 years up to 18 years and 15 up to 20 kg
      [3]
      • Days 1 to 3: 80 mg/day in 1 dose
    • 3 years up to 18 years and ≥ 20 kg
      [3]

      • Day 1: 125 mg/day in a single dose
        Days 2 and 3: 80 mg/day in a single dose
Prophylaxis for nausea and vomiting in chemotherapy for one-day or multi-day schedules
  • Intravenous
    • 6 months up to 18 years and ≥ 6 kg
      [5]
      • Initial dose: Day 1: 3 mg/kg/dose, once only. Max: 115 mg/day.
      • Maintenance dose: Day 2 and 3: 2 mg/kg/day in 1 dose. Max: 80 mg/day.

      • run in over 30 minutes for children aged ≥ 12 years and 60 minutes for children aged < 12. The infusion must be completed about 30 minutes before the start of chemotherapy.

        Maintenance dose can also be given orally.

  • Oral
    • 6 months up to 18 years and ≥ 6 kg
      [2]
      • Initial dose: Day 1: 3 mg/kg/dose, once only. Max: 125 mg/day.
      • Maintenance dose: Day 2 and 3: 2 mg/kg/day in 1 dose. Max: 80 mg/day. take in the morning.
Prophylaxis for nausea and vomiting in chemotherapy: ALTERNATIVE for one-day schedules
  • Intravenous
    • 6 months up to 2 years and ≥ 6 kg
      [5]
      • 5 mg/kg/dose, once only. Max: 150 mg/dose.
        • combined with a 5-HT3 antagonist plus a corticosteroid if required.
        • Run in over 60 minutes. The infusion must be completed about 30 minutes before the start of chemotherapy.
    • 2 years up to 12 years
      [5]
      • 4 mg/kg/dose, once only. Max: 150 mg/dose.
        • combined with a 5-HT3 antagonist plus a corticosteroid if required.
        • Run in over 60 minutes. The infusion must be completed about 30 minutes before the start of chemotherapy.
    • 12 years up to 18 years
      [5]
      • 150 mg/dose, once only.
        • combined with a 5-HT3 antagonist plus a corticosteroid if required.
        • Run in over 30 minutes.The infusion must be completed about 30 minutes before the start of chemotherapy.

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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

Hiccups, excessive flushing.

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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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Serotonin (5HT3) antagonists
A04AA02
A04AA01
A04AA05

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References

  1. Merck Sharp & Dohme Ltd., SmPC Emend poeder voor orale suspensie (EU 1/03/262/011) 12-06-2018, www.geneesmiddeleninformatiebank.nl
  2. Merck Sharp & Dohme Ltd., SmPC Emend tablet (EU 1/03/262/006) 12-06-2018, www.geneesmiddeleninformatiebank.nl
  3. Cristofori F et al. , Efficacy of the neurokinin-1 receptor antagonist aprepitant in children with cyclical vomiting syndrome., Aliment Pharmacol Ther., 2014 , Aug;40(3), 309-17
  4. Murphy C et al, NK1 receptor antagonism ameliorates nausea and emesis in typical and atypical variants of treatment refractory cyclical vomiting syndrome, J Pediatr Gastroenterol Nutr , 2006, 42, E13
  5. Merck, Sharpe & Dohme BV, SmPC Ivemend (Eu/1/07/437/003) 30-07-2018, www.geneesmiddeleninformatiebank.nl

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Changes

Changes