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artesunate

Artesunate Amivas · ATC code P01BE03

Also known as: Artesunat

Key facts
Active substance
artesunate
Drug class
Antimalarial
ATC code
P01BE03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Artesunate Amivas 110 mg powder and solvent for solution for injection
Marketing authorisation holder
Amivas Ireland Ltd
Information as of
2026-10-27

Key facts

Artesunate is an artemisinin antimalarial given intravenously for the initial treatment of severe malaria in adults and children.

What it is used for

  • Initial treatment of severe malaria in adults and children
  • Official guidance on the appropriate use of antimalarial agents should be considered

Dosing

  • Adults and children: 2.4 mg/kg by intravenous injection at 0, 12 and 24 hours
  • If oral treatment is not tolerated, after at least 24 hours: 2.4 mg/kg once every 24 hours
  • Stopped once oral treatment is tolerated, followed by a complete oral combination antimalarial course
  • No dose adjustment for elderly, renal or hepatic impairment, or by age/weight in children
  • Slow bolus injection over 1-2 minutes; reconstituted solution used within 1.5 hours

Contraindications

  • Hypersensitivity to the active substance, any other artemisinin antimalarial or any excipient

Important warnings

  • Allergic reactions including anaphylaxis, urticaria, rash and pruritus
  • Post-artesunate delayed haemolysis (PADH), onset at least 7 days after starting; monitoring for haemolytic anaemia for 4 weeks
  • PADH risk may be highest with hyperparasitaemia and in younger children; some cases required transfusion
  • Reticulocytopenia may occur

Side effects

  • Very common: anaemia, reduced reticulocyte count, post-artesunate delayed haemolysis
  • Others: rhinitis, anorexia, dizziness, dysgeusia, headache
  • Immune haemolytic anaemia and anaphylaxis have been reported

Interactions

  • Strong UGT inhibitors (e.g. axitinib, vandetanib, imatinib, diclofenac) may increase DHA exposure; avoided if possible
  • UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may reduce efficacy; to be avoided

Pregnancy and breastfeeding

  • Not recommended in the first trimester unless the benefit to the mother outweighs the risk to the fetus
  • Second/third trimester data show no malformative toxicity; as a precaution, use is preferably avoided

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Artesunate Amivas
Liechtenstein
Artesunate Amivas
Norway
Artesunate Amivas

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

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Sources

  1. European Medicines Agency. Artesunate Amivas – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/artesunate-amivas-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC P01BE.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.