1.2. Pediatrics

Table 3 summarizes the current pediatric FDA-approved indications and dosages of the available serotonin 5-HT3 receptor antagonists. Dolasetron and ondansetron are the only oral serotonin 5-HT3 receptor antagonists FDA-approved for the prevention of CINV in children 1. Currently, there are no oral 5-3 receptor antagonists approved for preventing PONV in children. Dolasetron is approved for use in children greater than 2 years of age; safety and efficacy in children less than 2 years of age have not been established 1,2,6 . Ondansetron is approved for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in children 4 years of age and older. There are no data available addressing the use of 24 mg ondansetron tablets for highly emetogenic chemotherapy in children1, 2, 9. Safety and efficacy of granisetron in children less than 18 years of age have not been established1, 2, 7, 8. Netupitant/palonosetron combination therapy is not approved in pediatric patients as safety and efficacy data are not available for this agent in this patient population1, 2, 5. No data are available evaluating serotonin 5-HT3 receptor antagonists for the use of RINV in pediatric patients.

Table 3. Maximum Recommended Oral Pediatric Dosages for Serotonin 5-HT3 Receptor Antagonists1,2,6,9
Drug Name Dosage Form/Strength Recommended Dosage Regimen - CINV Recommended Dosage Regimen - PONV Recommended Dosage Regimen - RINV
dolasetron (Anzemet®) 50 mg tablets Moderately emetogenic: 2-17 years old: 1.8 mg/kg, not to exceed 100 mg*# --- ---
  • ondansetron (generic, Zofran®)
  • ondansetron (generic, Zofran® ODT)
  • ondansetron (generic, Zofran®)
  • 4 mg, 8 mg, 24 mg tablets
  • 4 mg, 8 mg orally-disintegrating tablets
  • 4 mg/5 mL oral solution
  • Moderately emetogenic:
  • ≥12 years old: 8 mg twice daily**
  • 4-11 years old: 4 mg three times daily†
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Legend:

  • * Doses should be administered within 1 hour before chemotherapy
  • # For children who cannot take 100 mg due to weight or ability to swallow tablets, the injection solution may be mixed into apple or apple-grape juice for oral dosing in pediatric patients
  • ** The first dose should be given 30 minutes before the start of chemotherapy, with a second dose 8 hours after the first dose, followed by 8 mg twice daily (every 12 hours) continued for 1 to 2 days after completion of chemotherapy
  • † The first dose should be given 30 minutes before the start of chemotherapy, with subsequent doses 4 and 8 hours after the first dose, followed by 4 mg three times daily (every 8 hours) continued for 1 to 2 days after completion of chemotherapy