Ruconest

conestat alfa

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This is a summary of the European public assessment report (EPAR) for Ruconest. 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 Ruconest.

What is Ruconest?

Ruconest is a powder that is made up into a solution for injection. It contains the active substance conestat alfa.

What is Ruconest used for?

Ruconest is used to treat attacks of hereditary angioedema in adults (aged 18 years or over). 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. Ruconest is used in patients with hereditary angioedema that is linked to naturally low levels of a protein called ‘C1 esterase inhibitor’.

The medicine can only be obtained with a prescription.

How is Ruconest used?

Treatment with Ruconest should be started under the supervision of a doctor with experience in diagnosing and treating hereditary angioedema. The medicine should only be given by a healthcare professional. Patients who have not received Ruconest before should be tested to see if they have antibodies against rabbit dander (shed skin and hair) in their blood – they should only be given Ruconest if their tests are negative.

Ruconest is given by slow injection into a vein lasting around five minutes. The dose depends on the patient’s body weight. One injection is usually enough to treat an attack, but a second injection may be given if the patient does not improve enough after the first one. A patient should not be given more than two injections within any 24-hour period.

How does Ruconest work?

The C1-esterase-inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins in the blood that fight against infection and cause inflammation. Patients with low levels of this protein have excessive activity these two systems, which leads to the symptoms of angioedema. The active substance in Ruconest, conestat alfa, is a copy of the C1-esterase-inhibitor protein and works the same way as the natural human protein. When it is given during an angioedema attack, conestat alfa stops this excessive activity, helping to relieve the patient’s symptoms.

Conestat alfa is produced by ‘recombinant DNA technology’: it is extracted from the milk of rabbits that have been given genes that make them able to produce the human protein in their milk.

How has Ruconest been studied?

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

Ruconest was studied in two main studies involving a total of 73 patients with hereditary angioedema caused by low levels of C1-esterase-inhibitor protein. Most of the patients were adults. When an attack occurred, the patients were given one of two doses of Ruconest (50 or 100 units/kg) or placebo (a dummy treatment). Patients receiving the lower dose of Ruconest had the option of receiving a second dose up to four hours after the first. The main measure of effectiveness was how long it took for the symptoms to start to improve. Improvement was measured by the patients rating the severity of their symptoms on a scale from 0 to 100.

What benefit has Ruconest shown during the studies?

Ruconest was more effective than placebo at improving the symptoms of patients having an attack of angioedema. Patients receiving Ruconest at doses of 50 units/kg and 100 units/kg started to have improvements after one and two hours, respectively. Patients receiving placebo started to have improvements after four hours in one study and after over eight hours in the other.

Most patients were successfully treated with the 50-unit/kg dose, with only around 10% of the patients needing a second dose. This dose had a similar success rate to the higher dose of Ruconest.

What is the risk associated with Ruconest?

The most common side effect with Ruconest (seen in between 1 and 10 patients in 100) is headache. For the full list of all side effects reported with Ruconest, see the package leaflet.

Ruconest should not be used in people who may be hypersensitive (allergic) to conestat alfa or any of the other ingredients. It must not be used in patients with known or suspected allergy to rabbits.

Why has Ruconest been approved?

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

What measures are being taken to ensure the safe use of Ruconest?

The company that makes Ruconest will ensure that healthcare professionals in all Member States who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy. The company will also provide prescribers with an alert card for their patients.

Other information about Ruconest

The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest to Pharming Group N.V. on 28 October 2010. The marketing authorisation is valid for five years, after which it can be renewed.

Name Language First published Last updated
Ruconest : EPAR - Summary for the public BG = bălgarski 08/11/2010  
Ruconest : EPAR - Summary for the public ES = español 08/11/2010  
Ruconest : EPAR - Summary for the public CS = čeština 08/11/2010  
Ruconest : EPAR - Summary for the public DA = dansk 08/11/2010  
Ruconest : EPAR - Summary for the public DE = Deutsch 08/11/2010  
Ruconest : EPAR - Summary for the public ET = eesti keel 08/11/2010  
Ruconest : EPAR - Summary for the public EL = elliniká 08/11/2010  
Ruconest : EPAR - Summary for the public EN = English 08/11/2010  
Ruconest : EPAR - Summary for the public FR = français 08/11/2010  
Ruconest : EPAR - Summary for the public IT = italiano 08/11/2010  
Ruconest : EPAR - Summary for the public LV = latviešu valoda 08/11/2010  
Ruconest : EPAR - Summary for the public LT = lietuvių kalba 08/11/2010  
Ruconest : EPAR - Summary for the public HU = magyar 08/11/2010  
Ruconest : EPAR - Summary for the public MT = Malti 08/11/2010  
Ruconest : EPAR - Summary for the public NL = Nederlands 08/11/2010  
Ruconest : EPAR - Summary for the public PL = polski 08/11/2010  
Ruconest : EPAR - Summary for the public PT = português 08/11/2010  
Ruconest : EPAR - Summary for the public RO = română 08/11/2010  
Ruconest : EPAR - Summary for the public SK = slovenčina 08/11/2010  
Ruconest : EPAR - Summary for the public SL = slovenščina 08/11/2010  
Ruconest : EPAR - Summary for the public FI = suomi 08/11/2010  
Ruconest : EPAR - Summary for the public SV = svenska 08/11/2010  

This EPAR was last updated on 10/10/2013 .

Authorisation details

Product details

Product details for Ruconest
NameRuconest
Agency product numberEMEA/H/C/001223
Active substance

conestat alfa

International non-proprietary name (INN) or common name

conestat alfa

Therapeutic area Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code B06AC04

Publication details

Publication details for Ruconest
Marketing-authorisation holder

Pharming Group N.V.

Revision3
Date of issue of marketing authorisation valid throughout the European Union28/10/2010

Contact address:

Pharming Group N.V.
Darwinweg 24
NL-2333 CR Leiden
Netherlands

Product information

Product information

25/09/2013  Ruconest -EMEA/H/C/001223 -IA/0013

Name Language First published Last updated
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013
Ruconest : EPAR - Product Information SV = svenska 08/11/2010 10/10/2013

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
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  
Ruconest : EPAR - All Authorised presentations SV = svenska 08/11/2010  

Name Language First published Last updated
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  
Ruconest : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 08/11/2010  

Pharmacotherapeutic group

Other haematological agents

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ruconest : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 14/10/2011 10/10/2013

Initial marketing-authorisation documents

Name Language First published Last updated
Ruconest : EPAR - Public assessment report SV = svenska 08/11/2010  
CHMP positive summary of opinion for Ruconest SV = svenska 25/06/2010  

Authorised

This medicine is approved for use in the European Union