Ecalta

anidulafungin

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Ecalta?

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.

What is Ecalta used for?

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.

How is Ecalta used?

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.

How does Ecalta work?

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-β-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).

How has Ecalta been studied?

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.

What benefit has Ecalta shown during the studies?

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).

What is the risk associated with Ecalta?

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.

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 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.

Other information about Ecalta:

The European Commission granted a marketing authorisation valid throughout the European Union for Ecalta to Pfizer Limited on 20 September 2007.

Name Language First published Last updated
Ecalta : EPAR - Summary for the public BG = bălgarski 05/11/2009  
Ecalta : EPAR - Summary for the public ES = español 05/11/2009  
Ecalta : EPAR - Summary for the public CS = čeština 05/11/2009  
Ecalta : EPAR - Summary for the public DA = dansk 05/11/2009  
Ecalta : EPAR - Summary for the public DE = Deutsch 05/11/2009  
Ecalta : EPAR - Summary for the public ET = eesti keel 05/11/2009  
Ecalta : EPAR - Summary for the public EL = elliniká 05/11/2009  
Ecalta : EPAR - Summary for the public EN = English 05/11/2009  
Ecalta : EPAR - Summary for the public FR = français 05/11/2009  
Ecalta : EPAR - Summary for the public IT = italiano 05/11/2009  
Ecalta : EPAR - Summary for the public LV = latviešu valoda 05/11/2009  
Ecalta : EPAR - Summary for the public LT = lietuvių kalba 05/11/2009  
Ecalta : EPAR - Summary for the public HU = magyar 05/11/2009  
Ecalta : EPAR - Summary for the public MT = Malti 05/11/2009  
Ecalta : EPAR - Summary for the public NL = Nederlands 05/11/2009  
Ecalta : EPAR - Summary for the public PL = polski 05/11/2009  
Ecalta : EPAR - Summary for the public PT = português 05/11/2009  
Ecalta : EPAR - Summary for the public RO = română 05/11/2009  
Ecalta : EPAR - Summary for the public SK = slovenčina 05/11/2009  
Ecalta : EPAR - Summary for the public SL = slovenščina 05/11/2009  
Ecalta : EPAR - Summary for the public FI = suomi 05/11/2009  
Ecalta : EPAR - Summary for the public SV = svenska 05/11/2009  

This EPAR was last updated on 13/11/2013 .

Authorisation details

Product details

Product details for Ecalta
NameEcalta
Agency product numberEMEA/H/C/000788
Active substance

anidulafungin

International non-proprietary name (INN) or common name

anidulafungin

Therapeutic area Candidiasis
Anatomical therapeutic chemical (ATC) code J02AX06

Publication details

Publication details for Ecalta
Marketing-authorisation holder

Pfizer Limited

Revision12
Date of issue of marketing authorisation valid throughout the European Union20/09/2007

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

08/08/2013  Ecalta -EMEA/H/C/000788 -N/0025

Name Language First published Last updated
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013
Ecalta : EPAR - Product Information SV = svenska 15/10/2009 13/11/2013

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012
Ecalta : EPAR - All Authorised presentations SV = svenska 15/10/2009 06/09/2012

Pharmacotherapeutic group

Antimycotics for systemic use

Therapeutic indication

Treatment of invasive candidiasis in adult non-neutropenic patients.

Ecalta has been studied primarily in patients with candidaemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease (see section 4.4 and section 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ecalta : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 15/10/2009 13/11/2013
Ecalta-H-C-788-A20-19 : EPAR - Assessment Report - Article 20 SV = svenska 09/08/2012  

Initial marketing-authorisation documents

Name Language First published Last updated
Ecalta : EPAR - Procedural steps taken before authorisation SV = svenska 09/10/2007  
Ecalta : EPAR - Scientific Discussion SV = svenska 09/10/2007