FDA Approval of Artesunate for Injection for Treatment of Severe Malaria

Artesunate for InjectionTM was approved by the FDA on May 26, 2020 for treatment of severe malaria. Severe malaria is a potentially deadly disease characterized by at least one of the following: impaired consciousness/coma, severe anemia, acute kidney injury, acute respiratory distress syndrome, circulatory collapse/shock, disseminated intravascular coagulation, acidosis, jaundice and/or parasite density of ≥ 5%. Previously, the only intravenous (IV) antimalarial available to treat severe malaria in the United States was investigational IV artesunate solely available from CDC through an expanded-use investigational new drug (IND) protocol.

With FDA approval, and soon, commercial availability, hospitals will be able to stock IV artesunate for immediate treatment of patients with severe malaria to prevent poor outcomes such as death. Until Artesunate for Injection is commercially available, CDC will continue to make IV artesunate available through the IND protocol.

Artesunate for InjectionTM is indicated for those with severe malaria or those unable to tolerate oral antimalarials. Available in vials of 110mg, Artesunate for Injection is dosed at 2.4 mg/kg given intravenously at 0, 12 and 24 hours, then daily up to seven days, until the patient is able to tolerate oral medications. CDC recommends checking parasite density after 24 hours. If after 24 hours of artesunate, the percent parasitemia is ≤ 1% and the patient is able to tolerate oral medications, the patient can be switched to an oral antimalarial regimen. Artesunate for Injection can be given in infants, children, adults, and pregnant women. Post-artemisinin delayed hemolysis requiring transfusion has been reported. Monitoring of patients starting at 7 days and up to 4 weeks after receiving intravenous artesunate is recommended.

Further information on treatment of severe malaria and IV artesunate available from CDC can be found here.

Page last reviewed: May 28, 2020