Eurartesim

What is Eurartesim?

Eurartesim is a medicine that contains the active substances piperaquine tetraphosphate and dihydroartemisinin and is available as tablets (160 mg / 20 mg; 320 mg / 40 mg).

What is Eurartesim used for?

Eurartesim is used for the treatment of uncomplicated malaria caused by the Plasmodium falciparum parasite. The expression "uncomplicated" indicates that the disease does not imply severe and highly life-threatening symptoms. Eurartesim can be used in adults as well as in children 6 months of age and over and weighing 5 kg or more.

The medicine can only be obtained with a prescription.

How is Eurartesim used?

Eurartesim is taken once a day for three consecutive days, every day at the same time, according to a dosage based on the patient's body weight. The tablets should be swallowed with water and without food, at least three hours after meals. If necessary, they can be crushed and dissolved in water.

How does Eurartesim work?

Malaria is an infectious disease caused by a parasite known as Plasmodium and is transmitted through the bite of an infected mosquito. The active ingredients of Eurartesim, dihydroartemisinin and piperaquine tetraphosphate, are antimalarial agents that kill the P. falciparum parasite. Dihydroartemisinin is a derivative of artemisinin, a naturally occurring substance. Although it is still not entirely clear how it manages to kill the parasite, it is believed to do so by damaging the membrane of the parasite. Piperaquine tetraphosphate is a so-called bisquinoline, chemically related to other widely available agents for the treatment of malaria. It is believed to work by blocking a phase of the parasite metabolism necessary for its survival.

What studies have been carried out on Eurartesim?

The effects of Eurartesim were first tested in experimental models before being studied in humans.

Eurartesim has been researched in two main studies conducted on patients with uncomplicated P. falciparum malaria. In the first study, Eurartesim was compared with another antimalarial medicine containing artesunate and mefloquine in 1 150 patients. The main efficacy index was the percentage of patients recovered 63 days after treatment. In the second study, Eurartesim was compared with another antimalarial medicine containing artemether and lumefantrine in 1 553 children. The main efficacy index was the percentage of patients cured 28 days after treatment.

What benefit has Eurartesim shown during the studies?

Eurartesim has revealed its effectiveness in the treatment of uncomplicated P. falciparum malaria. In the first study, 63 days after treatment, 97% of patients given Eurartesim recovered, compared with 95% of patients treated with the comparator. In the second study, 93 days after treatment, 93% of patients who took Eurartesim recovered, compared with 95% of patients treated with the comparator.

What is the risk associated with Eurartesim?

In adults, the most common side effects of Eurartesim (seen in 1 - 10 patients in 100) are anemia (low erythrocyte counts), headache, prolongation of the QT interval (an alteration in the electrical activity of the heart, which can cause a fatal anomaly of heart rate), tachycardia (accelerated heart rate), asthenia (weakness) and pyrexia (fever). In children, the most common side effects of Eurartesim (seen in more than 1 patient in 10) were flu, cough and pyrexia. For the full list of all side effects reported with Eurartesim, see the package leaflet.

Eurartesim should not be used in people who are hypersensitive (allergic) to the active ingredients or any of the other ingredients. It must not be used in patients suffering from severe malaria (which can lead to death), or in patients who suffer or risk prolongation of the QT interval or cardiac arrhythmias (unstable heart rate) due to heart conditions, or who are taking medicines capable of affecting heart rate. Because of this risk of QT prolongation it is important that Eurartesim is taken without food and at least three hours after meals. Eurartesim should not be used during pregnancy if an effective alternative medicine exists. For the full list of limitations, see the package leaflet.

Why has Eurartesim been approved?

The CHMP considered that Eurartesim was effective in treating uncomplicated P. falciparum malaria, while its side effects were similar to those seen with comparable treatments. The CHMP noted the potential risk of developing prolongation of the QT interval and included restrictions in product information to minimize risks to patients. The committee noted that Eurartesim meets the recommendations of the World Health Organization in relation to the treatment of P. falciparum malaria, offering a new combination therapy with alternative artemisinin containing two active substances that act in different ways. Accordingly, the Committee decided that Eurartesim's benefits are greater than its risks and recommended that it be given marketing authorization.

What measures are being taken to ensure the safe use of Eurartesim

The company that markets Eurartesim will provide all doctors who should prescribe or use Eurartesim with a package containing important safety information on the correct use of the medicine, including a checklist of medicines with which Eurartesim should not be administered, with the intent to reduce the risk of prolonging the QT interval.