Artesunate

(Artesunate®)

Artesunate

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 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. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.

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Summary
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  • Artesunate (artesunate) is indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Primaquine + Artesunate-based Combination Therapies: High total dose primaquine (approximately 7 mg/kg) reduced P. vivax recurrence rates to 8.1%, compared to 19.3% with a low dose (approximately 3.5 mg/kg) and 51.0% without primaquine.
  • Artesunate-Mefloquine (ASMQ): Although ASMQ remains effective for treating uncomplicated P. falciparum malaria, studies with failure rates exceeding 10% indicate a reduction in efficacy in certain locations.
  • Intermittent Preventive Treatment in Infants (IPTi): IPTi with sulfadoxine-pyrimethamine (SP) reduced clinical malaria incidence by 30%, though the efficacy of SP declined over time.
  • Primaquine + Artesunate-based Combination Therapies: Increased gastrointestinal symptoms were observed with higher daily doses of primaquine, with 10.9% of patients on a high daily dose reporting symptoms compared to 4.0% with no primaquine.
  • Artesunate-Mefloquine (ASMQ): Serious adverse effects were infrequent, including seizures, encephalopathy, and cardiac arrhythmia. Local considerations are important, though no significant overall safety concerns were noted.
  • Pyronaridine-Artesunate: There was high-certainty evidence of increased alanine aminotransferase (ALT) levels (> 5x ULN), with one instance of moderate drug-induced liver injury reported. Fewer ECG abnormalities were noted compared to other antimalarials.
  • Artesunate Monotherapy vs. Artesunate + Adjunctive Therapy: No significant differences in the incidence of adverse reactions were observed between monotherapy and combination therapy groups.
  • Substantial reductions in uncomplicated and severe malaria were observed in children under 5 years and older than 5 years in studies on Seasonal Malaria Chemoprevention (SMC) and Intermittent Preventive Treatment in infants (IPTi). Patients with G6PD deficiency, particularly those with 30% to less than 70% G6PD activity, experienced significant haemoglobin reduction when treated with Primaquine + Artesunate-based combination therapies. Elevated ALT levels were notably associated with Pyronaridine-Artesunate use, indicating a potential risk of liver injury in this subgroup.

Product Monograph / Prescribing Information

Document TitleYearSource
Artesunate (Artesunate) Prescribing Information.2021Amivas LLC., Wilmington Delaware

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Meta-analysis on Plasmodium falciparum sulfadoxine-pyrimethamine resistance-conferring mutations in India identifies hot spots for genetic surveillance.2024International Journal of Antimicrobial Agents
Effect of primaquine dose on the risk of recurrence in patients with uncomplicated Plasmodium vivax: a systematic review and individual patient data meta-analysis.2024The Lancet. Infectious Diseases
Primaquine dose and the risk of haemolysis in patients with uncomplicated Plasmodium vivax malaria: a systematic review and individual patient data meta-analysis.2024The Lancet. Infectious Diseases
Systematic review and meta-analysis of seasonal malaria chemoprevention.2024The American Journal of Tropical Medicine and Hygiene
Artesunate-mefloquine therapy for uncomplicated Plasmodium falciparum malaria: an updated systematic review and meta-analysis of efficacy and safety.2024Transactions of The Royal Society of Tropical Medicine and Hygiene
Pyronaridine‐artesunate for treating uncomplicated Plasmodium falciparum malaria.2022Cochrane Database of Systematic Reviews
Intermittent preventive treatment for malaria in infants.2021Cochrane Database of Systematic Reviews
Safety and efficacy of adjunctive therapy with artesunate in the treatment of severe malaria: a systematic review and meta-analysis.2020Frontiers in Pharmacology
Systematic review of artesunate pharmacokinetics: Implication for treatment of resistant malaria. 2019International Journal of Infectious Diseases

Clinical Practice Guidelines

Document TitleYearSource
KDIGO 2021 clinical practice guideline for the management of glomerular diseases.2021Official Journal of the International Society of Nephrology