Drug updated on 10/28/2024
Dosage Form | Intravenous; 110 mg in a single-dose vial |
Drug Class | Antimalarials |
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
- 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 Title | Year | Source |
---|---|---|
Artesunate (artesunate) Prescribing Information. | 2023 | Amivas LLC., Wilmington Delaware |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Pregnancy outcomes after first-trimester treatment with artemisinin derivatives versus non-artemisinin antimalarials: a systematic review and individual patient data meta-analysis | 2023 | Lancet (London, England) |
Pyronaridine-artesunate for treating uncomplicated Plasmodium falciparum malaria | 2022 | The Cochrane Database of Systematic Reviews |
Safety of treating malaria with artemisinin-based combination therapy in the first trimester of pregnancy | 2022 | Reproductive Toxicology (Elmsford, N.Y.) |
Systematic review of artesunate pharmacokinetics: Implication for treatment of resistant malaria | 2019 | International Journal of Infectious Diseases |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Management of severe imported malaria in adults | 2020 | Medecine et Maladies Infectieuses |