What is Ecalta?
Ecalta comes in powder form for solution for infusion (drip into a vein), available with or without a solvent, and is based on the anidulafungin active ingredient.
What is Ecalta used for?
Ecalta is used to treat invasive candidiasis (a type of fungal infection caused by a yeast, called Candida ). The term "invasive" indicates that the fungus has spread into the blood. Ecalta is used only in non-neutropenic adults (who do not have low levels of neutrophils, a type of white blood cell).
The medicine can only be obtained with a prescription.
How is Ecalta used?
Treatment with Ecalta should be started by a doctor who is experienced in treating invasive fungal infections.
Ecalta is given at an initial dose of 200 mg on the first day, followed by 100 mg a day starting on the second day. To avoid side effects, Ecalta should only be administered as an infusion at a maximum rate of 1.1 mg per minute: this translates into about three hours for the initial infusion and one and a half hours for subsequent infusions. The duration of treatment depends on the patient's response. Generally, treatment should be continued for at least two weeks after the last detection of the fungus in the patient's blood.
How does Ecalta work?
The active ingredient of Ecalta, anidulafungin, is an antifungal drug, which belongs to the group of "echinocandins". It works by interfering with the production of a component of the fungal cell wall called 1, 3-β-D-glucan, which is necessary for the fungus to continue to live and grow. The fungal cells treated with Ecalta have incomplete or defective cell walls, which make them fragile and unable to grow. The list of fungi against which Ecalta is active can be consulted in the summary of product characteristics (also included with the EPAR).
How has Ecalta been studied?
Ecalta was evaluated in a main study involving 261 patients with invasive candidiasis. The effects of Ecalta have been compared with those of fluconazole (another antifungal drug). Both drugs were given by infusion for a period of 14 to 42 days. The main parameter to determine efficacy was based on the number of patients who responded to treatment, detected at the end of the same. A response was defined as a significant or complete improvement in symptoms, without the need for further antifungal treatment and without Candida traces in the patient's samples.
What benefits has Ecalta shown during the studies?
Ecalta was more effective than fluconazole in treating invasive candidiasis. At the end of therapy, 76% of patients treated with Ecalta (96 of 127) responded to treatment, compared to 60% of patients treated with fluconazole (71 of 118).
What is the risk associated with Ecalta?
The most common side effects seen with Ecalta (1-10 patients in 100 treated) are coagulopathy (problems with blood clotting), convulsions, headache, diarrhea, vomiting, nausea, increased levels of creatinine (a marker of kidney problems), blood rash, itching, hypokalemia (low blood potassium levels), flushing (redness of the skin) and increased 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, to any of the other components or to other drugs of the echinocandin class.
If the version of the medicine distributed with solvent is used, the infusion contains alcohol in a quantity similar to that of a small glass of wine or beer. This should be taken into consideration if the medicine is given to patients such as pregnant women, alcoholics or patients with liver disease. If the version of Ecalta without solvent is used, the powder must be dissolved in water and the resulting infusion does not contain alcohol.
Since Ecalta can affect the liver, patients who show signs of liver problems during treatment should be monitored closely.
Why has Ecalta been approved?
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 non-neutropenic adult patients.
However, the committee noted that the main Ecalta study included an insufficient number of patients with neutropenia to demonstrate the efficacy of the medicine in this group. He also noted that Ecalta has been studied mainly in patients with candidemia (presence of Candida in the blood) and only in a limited number of patients with deep tissue infections or abscesses. The committee therefore recommended that Ecalta be given marketing authorization.
Other information about Ecalta:
On 20 September 2007, the European Commission granted Ecizer a marketing authorization valid throughout the European Union to Pfizer Limited.
The full EPAR for Ecalta can be found here.
Last update of this summary: 07-2009.
