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. Artesunate for InjectionTM was approved by the FDA and is  commercially available in the United States.

FDA-approved artesunate is available for purchase from the major drug distributors: Amerisource Bergen, Cardinal, and McKesson. Hospitals that do not have Artesunate for InjectionTM  in stock should use the following steps when artesunate is needed to treat a patient with severe malaria:

  1. Hospital pharmacist should contact their drug distributor to request an EMERGENCY procurement of Artesunate for Injection. *Make sure to emphasize that this is an emergency procurement for a critically ill patient.
  2. If your hospital distributor is unable to provide artesunate then call Cardinal Specialty Pharmacy to request artesunate. Contact information for all distributors can be found hereexternal icon.
  3. If your hospital is unable to get in touch with a distributor, the pharmacist should call 855-5AMIVAS. If you leave a voice message at this number, your message will be returned within 30 minutes of your call.
  4. If the distributor is unable to get you a supply of artesunate within 24 hours, please follow the instructions below on how to contact CDC to request release of non-FDA approved artesunate under an investigational new drug protocol for treatment of your patient.

It may take some time between the commercial launch of Artesunate for InjectionTM, and stocking of drug in pharmacies and hospitals. During this time, CDC will continue to distribute non-FDA approved artesunate under its investigational new drug (IND) protocol for patients in situations where FDA-approved Artesunate for InjectionTM is not yet available within 24 hours of a clinician requesting the drug. When the distribution of Artesunate for InjectionTM expands nationwide and is stocked in the states where the most cases of malaria are found, CDC will discontinue its distribution of intravenous artesunate. CDC will monitor the availability of Artesunate for InjectionTM closely, and will provide additional communications prior to the discontinuation of its IND program for artesunate.

The indications for intravenous artesunate include the following:

  • 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

  • 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)

OR

  • Inability to take oral medications despite attempt after an oral antiemetic

Healthcare providers treating patients meeting the criteria above and who are unable to obtain commercially available artesunate within 24 hours 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 23, 2021