Malaria is a serious disease caused by infection with Plasmodium species that can cause life-threatening complications such as coma and multiorgan failure. The mortality risk is increased in certain populations, including children.

The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend intravenous (IV) artesunate (AS) as the first-line treatment for severe malaria [1, 2]. In May 2020, the Food and Drug Administration (FDA) approved Artesunate for Injection (in this paper, the term Artesunate for Injection refers to the FDA-approved product; prescribing information available at:; IV AS refers to all formulations) for the initial treatment of severe malaria at a dose of 2.4 mg/kg in adults and pediatric patients (the terms “pediatric patients” and “children” reflect terms used in FDA review documents/Artesunate for Injection Prescribing Information and WHO guidelines, respectively) in the United States (pending widespread commercial availability in the United States, IV AS continues to be available through a CDC expanded-use protocol.

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