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1.2. Pediatrics

Table 3 summarizes the current pediatric FDA-approved indications and dosages of the available serotonin 5-HT3 receptor antagonists. Ondansetron is the only oral serotonin 5-HT3 receptor antagonists FDA-approved for the prevention of CINV in children [1-6]. Currently, there are no oral 5-HT3¬ receptor antagonists approved for preventing PONV in children. 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 children [1,4-6]. Safety and efficacy of granisetron in children less than 18 years of age have not been established [1,2 ]. Netupitant/palonosetron combination therapy is not approved in pediatric patients as safety and efficacy data are not available for this agent in this patient population [1,9]. 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 Antagonists [1, 4-6]
Drug NameDosage Form/StrengthRecommended Dosage Regimen - CINVRecommended Dosage Regimen - PONVRecommended Dosage Regimen - RINV
  • 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:

  • ** 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