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

Interactions
PK
Renal impairment
References

Palonosetron

Generic name
Palonosetron
Brand name
ATC Code
A04AA05

Pharmacokinetics in children

 Pharmacokinetic parameters in children after administration of 20 mcg/kg in 15 min.

Age < 2 yrs 2–< 6 yrs 6–< 12 yrs 12–< 17 yrs
  N=3 N=5 N=7 N=10
AUC0-∞, (u·μg/l) 69.0 (49.5) 103.5 (40.4) 98.7 (47.7) 124.5 (19.1)
T1⁄2 (hours) 24 28 23.3 30.5
  N=6 N=14 N=13 N=19
Clearance (l/hr/kg) 0.31 (34.7) 0.23 (51.3) 0.19 (46.8) 0.16 (27.8)
Volume of distribution (l/kg) 6.08 (36.5) 5.29 (57.8) 6.26 (40.0) 6.20 (29.0)

An exposure-response analysis of palonosetron in children suggested that higher palonosetron systemic exposure is necessary for the prevention of CINV in the pediatric population, leading to approved pediatric dosing that results in mean AUC and Cmax that are approximately 3- and 10-fold higher, respectively, when compared with adults. [Momper 2020]

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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

Nausea and vomiting in chemotherapy
  • Intravenous
    • 1 month up to 18 years
      [1]
      • 30 minutes before the start of the chemotherapy 20 microg./kg/dose in 15 minutes. Max single dose: 1.500 microg./dose.

      • Children need higher exposure than adults to achieve similar response which explains why the registered dose for children is higher than for adults (Momper 2020). In daily practice, treatment of children is also started with the normal adult dose (250 mcg/dose) with good efficacy. If necessary, the dose can be increased.

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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

Common (1-10%): headaches

Uncommon (0.1-1%): Dizziness, dyskinesia, extended QT, conduction disorder, sinus tachycardia, coughing, dyspnoea, epistaxis, allergic dermatitis, pruritis, urticaria, pyrexia, pain at the infusion site, reaction at the infusion site, pain.

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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
Other antiemetics
A04AD12

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References

  1. Helsinn Birex Pharmaceuticals Ltd., SmPC Aloxi (EU/1/04/306/001) Rev 22, 19-07-2018, www.ema.europa.eu
  2. Momper JD, et al., Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting., J Clin Pharmacol , 2020, Jun;60(6), 775-784

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Changes

Changes