Ecalta is a powder that is made up into a solution for infusion (drip into a vein). Ecalta is available with or without a solvent. It contains the active substance anidulafungin.
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Ecalta is used to treat invasive candidiasis (a fungal infection caused by a yeast called Candida). ?Invasive? means that the fungus has spread into the blood. Ecalta is only used in adults who are not neutropenic (who do not have low levels of neutrophils, a type of white blood cell). The medicine can only be obtained with a prescription.
Treatment with Ecalta should be started by a doctor who has experience in the management of invasive fungal infections.
Ecalta is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two. Ecalta should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions. The duration of treatment depends on how the patient responds. In general, treatment should continue for at least two weeks after the last time that fungus is found in the patient?s blood.
The active substance in Ecalta, anidulafungin, is an antifungal medicine, which belongs to the group ?echinocandins?. It works by interfering with the production of a component of the fungal cell wall called 1,3-?-D-glucan, which is necessary for the fungus to continue living and growing. Fungal cells treated with Ecalta have incomplete or defective cell walls, making them fragile and unable to grow. The list of fungi against which Ecalta is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Ecalta has been studied in one main study involving 261 patients with invasive candidiasis. Ecalta was compared with fluconazole (another antifungal medicine). Both medicines were given by infusion, for between 14 and 42 days. The main measure of effectiveness was the number of patients who had responded to treatment at the end of the treatment course. A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient.
Ecalta was more effective than fluconazole in treating invasive candidiasis. At the end of the treatment course, 76% of the patients receiving Ecalta had responded to treatment (96 out of 127), compared with 60% of the patients receiving fluconazole (71 out of 118).
The most common side effects with Ecalta (seen in between 1 and 10 patients in 100) are coagulopathy (problems with blood clotting), convulsion (fits), headache, diarrhoea, vomiting, nausea (feeling sick), increased blood creatinine levels (a marker of kidney problems), rash, pruritus (itching), hypokalaemia (low blood potassium levels), flushing (reddening of the skin), and raised blood levels of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin and gamma-glutamyltransferase (markers of liver problems). For the full list of all side effects reported with Ecalta, see the Package Leaflet.
Ecalta should not be used in people who may be hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class.
If the version of Ecalta that is supplied with a solvent is used, the resulting infusion contains a similar amount of alcohol to a small glass of wine or beer. This will need to be taken into account when it is given to some patients such as pregnant women, alcoholics or people with liver disease. If the version of Ecalta that is supplied without a solvent is used, the powder is dissolved in water and the resulting infusion does not contain any alcohol.
Because Ecalta can affect the liver, patients who show signs of liver problems during treatment should be carefully monitored.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta?s benefits are greater than its risks for the treatment of invasive candidiasis in adult non-neutropenic patients. However, the Committee noted that the main study of Ecalta included an insufficient number of patients with neutropenia to demonstrate the medicine?s effectiveness in this group. In addition, it noted that Ecalta has been studied mainly in patients with candidaemia ( Candida in the blood) and only in a limited number of patients with deep tissue infections or abscesses. The Committee recommended that Ecalta be given marketing authorisation.