Artesunate

(Artesunate®)

Artesunate

Drug updated on 10/28/2024

Dosage FormIntravenous; 110 mg in a single-dose vial
Drug ClassAntimalarials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the initial treatment of severe malaria in adult and pediatric patients.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Artesunate-based treatments (ABTs) in the first trimester of pregnancy showed fewer adverse pregnancy outcomes (5.7%) compared to non-ABTs (8.9%), with an adjusted hazard ratio (aHR) of 0.71 (95% CI (confidence interval) 0.49-1.03). Artemether-lumefantrine, an ABT, had fewer adverse outcomes (4.8%) compared to oral quinine (9.2%), aHR = 0.58 (95% CI 0.36-0.92).
  • Pyronaridine-artesunate for uncomplicated malaria had a PCR-adjusted treatment failure rate of less than 5%. Compared to artemether-lumefantrine, unadjusted failures at day 28 were significantly lower (RR (relative risk) 0.27, 95% CI 0.13-0.58). Unadjusted failures at day 42 were also reduced (RR 0.61, 95% CI 0.46-0.82).
  • Intravenous (IV) artesunate showed strong dose-concentration relationships (R² > 0.9) for dihydroartemisinin (DHA) and favorable Cav/50 (EC)(50) ratios, while the oral route had less favorable Cav/EC(50) ratios, indicating potential for therapeutic failure with a two-fold increase in EC(50).
  • Artesunate in the first trimester of pregnancy showed no evidence of embryotoxicity or teratogenicity, based on miscarriage, stillbirth, and major congenital anomalies data.
  • Pyronaridine-artesunate was associated with raised liver enzymes (ALT (alanine aminotransferase): RR 3.59, 95% CI 1.76-7.33; AST (aspartate aminotransferase): RR 2.22, 95% CI 1.12-4.41) but no significant effect on bilirubin (RR 1.03, 95% CI 0.49-2.18). ECG (electrocardiogram) abnormalities were less common compared to other antimalarials.
  • The reviewed studies highlight population considerations, including pregnant women in the first trimester for adverse pregnancy outcomes and safety, and children under five years for efficacy, with participants from Africa and Asia also included in the efficacy analysis.

Product Monograph / Prescribing Information

Document TitleYearSource
Artesunate (artesunate) Prescribing Information.2023Amivas LLC., Wilmington Delaware

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Management of severe imported malaria in adults2020 Medecine et Maladies Infectieuses