Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 110 mg of artesunate as a powder in a single-dose vial for constitution with the supplied sterile diluent) |
| Drug Class | Antimalarials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the initial treatment of severe malaria in adult and pediatric patients.
- For the treatment of severe malaria. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
Summary
- Artesunate (Artesunate) is indicated for the initial treatment of severe malaria in both adult and pediatric patients.
- A total of 3 systematic reviews/meta-analyses were reviewed, providing insights into the use and effectiveness of Artesunate in treating severe malaria.
- One review found that intermittent preventive treatment with antimalarial drugs including Artesunate reduces the risk of clinical malaria, anaemia, and hospital admission among infants living in sub-Saharan Africa where there's moderate to high transmission rate.
- Another study compared artesunate monotherapy with artesunate combined with adjunctive therapies for severe malaria; it concluded that no significant differences exist between these two approaches regarding safety or efficacy.
- The third document highlighted a potential concern about resistance development against artemisinins like Artesunate especially when administered orally; suggesting a need for dose escalation or therapeutic drug monitoring to optimize drug exposure while preventing resistance development.
- Despite variations across studies due to factors such as geographical location and patient age group, overall evidence suggests that Artesunate remains an effective option for managing severe cases of Malaria but further research may be needed particularly on its oral administration regimen considering emerging parasite resistances reported from Southeast Asia region specifically.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Artesunate (Artesunate) Prescribing Information. | 2021 | Amivas LLC, Wilmington Delaware |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Assessment report: Artesunate Amivas. | 2021 | EMA |
| Intermittent preventive treatment for malaria in infants. | 2021 | Cochrane Database of Systematic Reviews |
| Safety and Efficacy of Adjunctive Therapy With Artesunate in the Treatment of Severe Malaria: A Systematic Review and Meta-Analysis. | 2020 | Frontiers in pharmacology |
| Systematic review of artesunate pharmacokinetics: Implication for treatment of resistant malaria. | 2019 | International Journal of Infectious Diseases |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Review of UK malaria treatment guidelines 2016 (Public Health England Advisory Committee on Malaria Prevention). | 2018 | Archives of Disease in Childhood: Education & Practice |