Drug updated on 9/4/2024
Dosage Form | Injection (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. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Artesunate (Artesunate) Prescribing Information. | 2021 | Amivas LLC., Wilmington Delaware |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
KDIGO 2021 clinical practice guideline for the management of glomerular diseases. | 2021 | Official Journal of the International Society of Nephrology |