Is injection artesunate (artemisinin derivative) safe for use in infants under 1 month of age?

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Last updated: June 27, 2025View editorial policy

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From the Research

Intravenous artesunate is considered safe and is recommended for treating severe malaria in neonates under 1 month of age, with a recommended dosage of 3 mg/kg body weight administered intravenously at 0,12, and 24 hours, then once daily until oral therapy can be started, as supported by the most recent study in 2023 1.

Key Points to Consider

  • The World Health Organization recommends artesunate as the first-line treatment for severe malaria in all age groups, including neonates.
  • While clinical data specifically in neonates is more limited than in older children, the available evidence suggests that artesunate has a favorable safety profile in this age group with no significant adverse effects reported.
  • Artesunate works by rapidly clearing parasites from the bloodstream and is preferred over quinine due to its superior efficacy and better safety profile.
  • Close monitoring of the infant during treatment is essential, with particular attention to vital signs, neurological status, and parasitemia levels.
  • A recent study in 2023 1 supports the use of 3 mg/kg dosing for all children, including those under 20 kg, as it ensures adequate drug exposure and minimizes the risk of underdosing.

Important Considerations

  • The study in 2023 1 used population pharmacokinetic modeling to determine the optimal dosing of intravenous artesunate in children with severe falciparum malaria.
  • The results of this study suggest that the majority of younger children given the lower 2.4 mg/kg dose of intravenous artesunate do not reach the same drug exposures as older children above 20 kg.
  • Therefore, the use of 3 mg/kg dosing is recommended to ensure adequate treatment and minimize the risk of underdosing.
  • It is also important to note that artesunate has been shown to reduce mortality in African children with severe malaria, as demonstrated in a study in 2010 2.
  • Additionally, artesunate has been associated with a lower risk of delayed haemolysis compared to quinine, as reported in a study in 2015 3.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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