No FDA-approved injectable malaria medication has been available in the US
since IV quinidine was discontinued in early 2019. Artesunate for Injection fills this need.
Until Amivas (US), LLC stocks have transitioned through the hospital supply chain, healthcare professionals seeking Artesunate for Injection for patients with severe malaria should contact the Center for Disease Control and Prevention (CDC) for information on product ordering from CDC quarantine stations. This transition will progress rapidly in coming months. Updates will appear here along with the CDC webpages.
Fast acting, effective, and easy to use. Artesunate for Injection is recommended by the
CDC and the World Health Organization (WHO).
- Artesunate for Injection is recommended by the WHO as first-line treatment for severe malaria and has been used extensively around the world for more than 20 years.
- The CDC recommends Artesunate for Injection for all patients with severe malaria, regardless of the infecting species of malaria parasite, and has provided Artesunate for Injection on a compassionate use basis from the US Army.
- Artesunate for Injection is appropriate for adults and children. Clinical studies of Artesunate for Injection did not include sufficient patients 65 years of age and older to determine whether they respond differently than younger patients.
Symptoms of the disease can vary widely but severe malaria typically includes neurologic symptoms, severe anemia (hemoglobin level < 70 g/L), hyperparasitemia (> 5%), acute renal injury, acute respiratory distress syndrome, or jaundice.1-3
Severe malaria causes an estimated 405,000 deaths annually around the world, the majority of them in young children.4
In the US, approximately 15% of cases are severe.5,6
Most of these are acquired through travel to malaria-endemic countries.
Rapid-acting artemisinin derivatives such as Artesunate for Injection offers patients and healthcare providers an important therapy.
- Artesunate for Injection is associated with up to a 34.7% reduction in risk of mortality compared with quinine.7,8
- Supplied as a sterile powder, Artesunate for Injection can be safely stored at room temperature.
- Artesunate for Injection is easily constituted in one step.
- View and download Artesunate for Injection dosing information here.
Important Safety Information
Known serious hypersensitivity to artesunate, such as anaphylaxis.
Warnings and Precautions
Post Artesunate Delayed Hemolysis: Post-artesunate delayed hemolysis is characterized by decreased hemoglobin with laboratory evidence of hemolysis (such as decreased haptoglobin and increased lactate dehydrogenase) occurring at least 7 days after initiating artesunate treatment. Cases of post-treatment hemolytic anemia severe enough to require transfusion have been reported. Monitor patients for 4 weeks after artesunate treatment for evidence of hemolytic anemia. Since a subset of patients with delayed hemolysis after artesunate therapy have evidence of immune-mediated hemolysis, consider performing a direct antiglobulin test to determine if therapy, e.g. corticosteroids, is necessary.
Hypersensitivity reactions: Hypersensitivity to artesunate including cases of anaphylaxis have been reported during the use of parenteral artesunate (including Artesunate for Injection). If hypotension, dyspnea, urticaria, or generalized rash occur during administration of Artesunate for Injection, consider discontinuing Artesunate for Injection administration and continuing therapy with another antimalarial drug.
The most common adverse reactions (2 percent or greater) occurring more frequently in patients receiving intravenous artesunate in the SEAQUAMAT trial were acute renal failure requiring dialysis, hemoglobinuria, and jaundice. The most common adverse reactions in the CDC expanded access protocol were anemia (65 percent), transaminase increase (27 percent), thrombocytopenia (18 percent), hyperbilirubinemia (14%), acute renal failure (10 percent), leukocytosis (10 percent), acute respiratory distress syndrome (8 percent), lymphopenia (7 percent), neutropenia (5 percent), disseminated intravascular coagulation (3 percent), elevated creatinine (3 percent), pneumonia (3 percent), pulmonary edema (3 percent), and diarrhea (3 percent).
Published clinical reports or in vitro reports indicate that concomitant use of Artesunate for Injection with oral ritonavir, nevirapine, or UGT inducers may decrease dihydroartemisinin (DHA) AUC and Cmax, which may reduce the efficacy of Artesunate for Injection. If Artesunate for Injection is co-administered with ritonavir, nevirapine or strong UGT inducers (e.g., rifampin, carbamazepine, phenytoin), monitor for possible reduced antimalarial efficacy of Artesunate for Injection.
Published reports of in vitro data indicate that concomitant use of Artesunate for Injection with UGT inhibitors may increase DHA AUC and Cmax, which may increase DHA associated adverse reactions. Monitor for adverse reactions when co-administering Artesunate for Injection with strong UGT inhibitors (e.g., axitinib, vandetanib, imatinib, diclofenac).
Use in Specific Populations
Pregnancy: There are serious risks to the mother and fetus associated with untreated severe malaria during pregnancy; delaying treatment of severe malaria in pregnancy may result in serious morbidity and mortality to the mother and fetus. Pregnancy outcomes reported from a prospective surveillance study with intravenous artesunate are insufficient to identify a drug-associated risk of major births defects, miscarriage, and or fetal death.
Pediatric Use: The safety and effectiveness of Artesunate for Injection for the treatment of severe malaria have been established in pediatric patients.
Geriatric Use: Clinical studies of Artesunate for Injection did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger subjects.
To report SUSPECTED ADVERSE REACTIONS, contact Amivas LLC at [1-855-526-4827 (1-855-5AMIVAS)] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Centers for Disease Control and Prevention. Malaria Treatment (United States). https://www.cdc.gov/malaria/diagnosis_treatment/treatment.html
- Twomey PS, Smith BL, McDermott C, et al. Intravenous Artesunate for the Treatment of Severe and Complicated Malaria in the United States: Clinical Use Under an Investigational New Drug Protocol. Ann Intern Med. 2015;163(7):498‐ doi:10.7326/M15-0910
- World Health Organization. Guidelines for the Treatment of Malaria. Third edition, April 2015. https://www.who.int/malaria/publications/atoz/9789241549127/en/
- World Health Organization. World malaria report 2019. https://www.who.int/malaria/publications/world-malaria-report-2019/en/
- Centers for Disease Control and Prevention. CDC and Malaria. https://www.cdc.gov/malaria/about/activities.html
- Centers for Disease Control and Prevention. Intravenous Artesunate for Treatment of Severe Malaria in the United States. https://www.cdc.gov/malaria/diagnosis_treatment/artesunate.html
- Dondorp A, Nosten F, Stepniewska K, Day N, White N; South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet. 2005;366(9487):717‐ doi:10.1016/S0140-6736(05)67176-0
- Dondorp AM, Fanello CI, Hendriksen IC, et al. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial [published correction appears in Lancet. 2011 Jan 8;377(9760):126]. Lancet. 2010;376(9753):1647‐ doi:10.1016/S0140-6736(10)61924-1