Firazyr

icatibant

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This is a summary of the European public assessment report (EPAR) for Firazyr. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Firazyr.

What is Firazyr?

Firazyr is a solution for injection that contains the active substance icatibant.

What is Firazyr used for?

Firazyr is used to treat the symptoms of attacks of hereditary angioedema in adults. Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called ‘C1 esterase inhibitor’.

Because the number of patients who have angioedema is low, the disease is considered ‘rare’, and Firazyr was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 February 2003.

The medicine can only be obtained with a prescription.

How is Firazyr used?

Firazyr is given as a slow injection under the skin, preferably in the abdomen (tummy). The recommended dose of Firazyr is one injection. If symptoms continue or come back, a second injection can be given after six hours. If needed, treatment can be repeated for a third time after an additional six hours. No more than three injections should be given in any 24-hour period.

The doctor may decide that the patient or their caregiver can administer the medicine themselves, after they have been properly trained by a healthcare professional.

How does Firazyr work?

Patients with hereditary angioedema have high levels of a substance called ‘bradykinin’, which is involved in causing inflammation and swelling. The active substance in Firazyr, icatibant, blocks the receptors that bradykinin normally attaches itself to. This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.

How has Firazyr been studied?

Firazyr has been studied in two main studies in patients with angioedema of the skin or the abdomen. The first study compared Firazyr with tranexamic acid (another medicine for hereditary angioedema) in 74 patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients. The main measure of effectiveness was how long it took until the patient’s symptoms were relieved.

What benefit has Firazyr shown during the studies?

Firazyr was more effective than tranexamic acid and placebo in relieving the symptoms of the disease. In both studies, the time it took for the patient’s symptoms to improve was shorter for patients taking Firazyr than for those taking tranexamic acid or placebo. Patients experienced relief an average of 2.0 to 2.5 hours after receiving Firazyr, compared with 12.0 hours for tranexamic acid in one study and 4.6 hours for placebo in the other study.

What is the risk associated with Firazyr?

The most common side effects with Firazyr (seen in more than 1 patient in 10) are erythema (redness), swelling, burning, itching and pain at injection sites. For the full list of all side effects reported with Firazyr, see the package leaflet.

Firazyr should not be used in people who may be hypersensitive (allergic) to icatibant or to any of the other ingredients.

Why has Firazyr been approved?

The CHMP decided that Firazyr’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Firazyr

The European Commission granted a marketing authorisation valid throughout the European Union for Firazyr to Shire Orphan Therapies GmbH on 11 July 2008. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Firazyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Firazyr : EPAR - Summary for the public BG = bălgarski 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public ES = español 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public CS = čeština 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public DA = dansk 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public DE = Deutsch 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public ET = eesti keel 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public EL = elliniká 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public EN = English 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public FR = français 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public IT = italiano 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public LV = latviešu valoda 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public LT = lietuvių kalba 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public HU = magyar 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public MT = Malti 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public NL = Nederlands 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public PL = polski 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public PT = português 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public RO = română 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public SK = slovenčina 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public SL = slovenščina 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public FI = suomi 14/07/2008 01/12/2011
Firazyr : EPAR - Summary for the public SV = svenska 14/07/2008 01/12/2011

This EPAR was last updated on 27/03/2013 .

Authorisation details

Product details

Product details for Firazyr
NameFirazyr
Agency product numberEMEA/H/C/000899
Active substance

icatibant

International non-proprietary name (INN) or common name

icatibant

Therapeutic area Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code C01EB19
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Firazyr
Marketing-authorisation holder

Shire Orphan Therapies GmbH

Revision9
Date of issue of marketing authorisation valid throughout the European Union11/07/2008

Contact address:

Shire Orphan Therapies GmbH
Friedrichstrasse 149
D-10117 Berlin
Germany

Product information

Product information

13/03/2013  Firazyr -EMEA/H/C/000899 -R/0022

Name Language First published Last updated
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013
Firazyr : EPAR - Product information SV = svenska 14/07/2009 27/03/2013

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
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012
Firazyr : EPAR - All authorised presentations SV = svenska 01/12/2008 25/09/2012

Pharmacotherapeutic group

Cardiac therapy

Therapeutic indication

Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Firazyr : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 14/07/2009 27/03/2013

Initial marketing-authorisation documents

Name Language First published Last updated
Firazyr : EPAR - Public assessment report SV = svenska 21/07/2008  
Committee for medicinal products for human use summary of positive opinion for Firazyr SV = svenska 28/04/2008