Intravenous Artesunate for Treatment of Severe Malaria in the United States

There are approximately 300 cases of severe malaria in the United States each year, most of them acquired from travel to malaria-endemic countries. Severe malaria should be treated with intravenous (IV) antimalarial medications. IV artesunate is the first-line drug for treatment of severe malaria in the United States. Recently, Artesunate for InjectionTM was approved by the FDA and will be manufactured, distributed, and commercially available in the United States. In the interim, until the time when intravenous artesunate is readily available commercially, CDC will continue to provide IV artesunate under an expanded-access investigational new drug (IND) protocol for patients with severe malaria and patients with uncomplicated malaria who are unable to take oral medications in the United States. The use of this drug under the IND protocol requires the following criteria to be met:

  • Malaria confirmation by microscopy. In exceptional cases and after discussion with a CDC Malaria Branch clinician, microscopic diagnosis might be waived. Those include a patient with strong clinical suspicion of malaria for whom a timely, reliable microscopic diagnosis is not available; AND
  • Parenteral treatment required due to one or more of the following reasons:
    • Severe malaria based on at least one of the following:
      • High parasite density (≥5%)
      • Impaired consciousness
      • Seizures
      • Circulatory collapse/shock
      • Pulmonary edema or acute respiratory distress syndrome (ARDS)
      • Acidosis
      • Acute kidney injury
      • Abnormal bleeding or disseminated intravascular coagulation (DIC)
      • Jaundice (must be accompanied by at least one other sign)
      • Severe anemia (Hb <7 g/dL)
    • Inability to take oral medications despite attempt after an oral antiemetic
    • Inability to obtain commercially available IV artesunate within 24 hours

Healthcare providers treating patients with severe malaria should call CDC to obtain IV artesunate. The CDC Malaria Hotline (770-488-7788) is available Monday–Friday, 9 am–5 pm EST. Outside these hours, providers should call 770-488-7100 and ask to speak with a CDC Malaria Branch clinician. When calling, please have the following information available:

  1. Patient’s information (name, date of birth, sex, weight, medical record number)
  2. Patient’s detailed clinical and laboratory information
  3. Hospital name and address
  4. Treating physician’s contact information (name, phone number, email address)
  5. Pharmacist’s contact information (name, phone number, email address)

IV artesunate provided by CDC is prepositioned throughout the United States at distribution sites and is sent free of charge to the major commercial airport closest to the requesting hospital. We anticipate that hospitals can expect timely delivery of IV artesunate, but delivery times vary depending on the requesting hospital’s proximity to the point of distribution and flight availability. Since severe malaria can progress rapidly, CDC has guidance on interim oral treatment while waiting for IV artesunate to arrive.

Page last reviewed: June 10, 2020