Artesunate Amivas
Authorised
This medicine is authorised for use in the European Union
artesunate
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Artesunate Amivas is a malaria medicine used as initial treatment of severe malaria in adults and children. Malaria is an infection caused by a parasite known as Plasmodium. ‘Severe’ malaria means the disease involves potentially life-threatening symptoms.
Malaria is rare in the EU, and Artesunate Amivas was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 28 February 2020.
Artesunate Amivas contains the active substance artesunate.
Artesunate Amivas can only be obtained with a prescription, and prescribers should take into account official guidance on the use of antimalarial agents. The medicine should only be used after consultation with a doctor experienced in the management of malaria.
The medicine is available as a powder and solvent to be made up into a solution for injection into a vein. The recommended dose is based on the patient’s weight and should be given every 12 hours during the first 24 hours (0, 12 and 24 hours). Treatment with Artesunate Amivas should continue with one injection every 24 hours until the patient is able to take appropriate malaria treatment by mouth.
For more information about using Artesunate Amivas, see the package leaflet or contact your doctor or pharmacist.
The active substance in Artesunate Amivas, artesunate, is a derivative of the naturally occurring substance artemisinin. Its exact mode of action is not fully understood, but once it has entered blood cells infected by the malaria parasite, the medicine is thought to form toxic substances called ‘free radicals’ that kill the parasite.
Two main studies showed that initial treatment with injectable artesunate was more effective than that with another malaria medicine, quinine, in reducing the risk of death in hospitalised patients with severe malaria.
The first study involved 1,461 adults and children. Patients received injectable treatment until they were able to receive treatment by mouth, either with Artesunate Amivas or with quinine. The results showed that 107 out of 730 (14.7%) patients who received initial treatment with Artesunate Amivas died in hospital compared with 164 out of 731 (22.4%) of those who received initial treatment with quinine.
In the second study, which involved 5,425 children under 15 years of age hospitalised with malaria, 230 out of 2712 (8.5%) patients who received Artesunate Amivas by injection followed by treatment with the malaria medicine artemether-lumefantrine died in hospital compared with 297 out of 2713 (10.9%) of those who received quinine by injection followed by artemether-lumefantrine.
The most common side effects with Artesunate Amivas (which may affect more than 1 in 10 people) are anaemia (low levels of red blood cells), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and post-artesunate delayed haemolysis (breakdown of red blood cells at least seven days after starting artesunate treatment, which may cause anaemia).
For the full list of side effects and restrictions of Artesunate Amivas, see the package leaflet.
Two studies have shown that initial treatment with Artesunate Amivas given by injection improves in-hospital survival in adults and children with severe malaria compared with quinine given by injection. The safety profile of Artesunate Amivas when given by injection into a vein was considered acceptable. The European Medicines Agency therefore decided that Artesunate Amivas’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Artesunate Amivas have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Artesunate Amivas are continuously monitored. Suspected side effects reported with Artesunate Amivas are carefully evaluated and any necessary action taken to protect patients.
Artesunate Amivas received a marketing authorisation valid throughout the EU on 22 November 2021.
Product information
Latest procedure affecting product information:
IB/0016
25/06/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Artesunate Amivas
- Active substance
- artesunate
- International non-proprietary name (INN) or common name
- artesunate
- Therapeutic area (MeSH)
- Malaria
- Anatomical therapeutic chemical (ATC) code
- P01BE03
Pharmacotherapeutic group
AntiprotozoalsTherapeutic indication
Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children.
Consideration should be given to official guidance on the appropriate use of antimalarial agents.
News on Artesunate Amivas
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