Tafenoquine paediatric


Product vision
  • Product targeting prevention of relapse for P. vivax
  • Single-dose treatment in children who cannot take the adult tablet
  • 50 mg child-friendly dispersible tablet formulation. Dosing scheme maintains target exposure in all weight bands
  • Efficacy in adults established when used with chloroquine
  • Paediatric pharmacokinetic bridging study shows relapse-free efficacy rate at 4 months of 95% (95% confidence interval: 85%; 98%) in children <16 years of age
Key features
  • Single-dose treatment to prevent relapse of P. vivax malaria
  • Quantitative testing for G6PD deficiency required

  • Contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Marketing authorization application (MAA) variation/line extension under review by the Australian Therapeutic Goods Administration (TGA)
Next milestone
  • MAA approval by TGA
MMV Project Director
  • Dr Isabelle Borghini-Fuhrer