Respreeza

human alpha1-proteinase inhibitor

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This is a summary of the European public assessment report (EPAR) for Respreeza. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Respreeza.

For practical information about using Respreeza, patients should read the package leaflet or contact their doctor or pharmacist.

What is Respreeza and what is it used for?

Respreeza is a medicine used in adults with alpha1-proteinase inhibitor deficiency, an inherited disorder that can cause lung problems such as increasing shortness of breath and which may also affect the liver. Respreeza is used to slow down damage to the lungs in patients with severe disease.

Respreeza contains the active substance human alpha1-proteinase inhibitor.

How is Respreeza used?

Respreeza is available as a powder and solvent to be made into a solution for infusion (drip) into a vein. The first infusion should be given under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency. Subsequent infusions can be given by a caregiver or by the patient.

The recommended dose of Respreeza is 60 mg per kilogram body weight, given once a week. The infusion should last around 15 minutes.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Respreeza work?

The active substance in Respreeza, human alpha1-proteinase inhibitor, is a natural protein in the blood which protects lung tissue from damage. It is obtained from human blood and works by replacing the protein that is lacking in patients with alpha1-proteinase inhibitor deficiency.

What benefits of Respreeza have been shown in studies?

Respreeza has been shown to slow down lung damage in one main study involving 180 patients with lung damage due to alpha1-proteinase inhibitor deficiency. In the study, Respreeza was compared with placebo (a dummy treatment) and the main measure of effectiveness was the decrease in lung density. Lung density is an indicator of the extent of lung damage: the bigger the decrease in lung density, the greater is the damage to the lung. The decrease in lung density after 24 months was around 2.6 g/l in patients who received Respreeza, compared with a decrease of around 4.2 g/l in patients receiving placebo.

What are the risks associated with Respreeza?

The most common side effects with Respreeza (which may affect up to 1 in 10 people) are dizziness, headache, dyspnoea (shortness of breath) and nausea. Allergic reactions have been observed during treatment, some of which were severe.

Because of the risk of severe allergic reactions, Respreeza must not be used in patients who are lacking IgA, a protein in the blood, and who have developed antibodies against it because these patients are more prone to allergic reactions. For the full list of all side effects and restrictions with Respreeza, see the package leaflet.

Why is Respreeza approved?

The main study with Respreeza showed that the medicine is effective at slowing down the damage to the lungs in patients with alpha1-proteinase inhibitor deficiency, and this effect is considered relevant for patients with severe disease. Allergic reactions were the main safety concern with Respreeza, but advice on how to manage this risk has been included in the product information. No other major concerns have been identified about the safety of the medicine.

Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Respreeza?

The company that markets Respreeza will carry out a further study to assess whether an increased dose of 120 mg/kg may lead to improved effects compared with the currently recommended dose.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Respreeza have also been included in the summary of product characteristics and the package leaflet.

Other information about Respreeza

The European Commission granted a marketing authorisation valid throughout the European Union for Respreeza on 20 August 2015.

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

Name Language First published Last updated
Respreeza : EPAR - Summary for the public BG = bălgarski 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public ES = español 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public CS = čeština 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public DA = dansk 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public DE = Deutsch 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public ET = eesti keel 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public EL = elliniká 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public EN = English 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public FR = français 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public IT = italiano 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public LV = latviešu valoda 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public LT = lietuvių kalba 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public HU = magyar 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public MT = Malti 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public NL = Nederlands 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public PL = polski 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public PT = português 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public RO = română 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public SK = slovenčina 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public SL = slovenščina 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public FI = suomi 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public SV = svenska 2015-09-16 2016-10-03
Respreeza : EPAR - Summary for the public HR = Hrvatski 2015-09-16 2016-10-03
Name Language First published Last updated
Respreeza : EPAR - Risk-management-plan summary (English only) 2015-09-16  

This EPAR was last updated on 26/10/2016 .

Authorisation details

Product details

Product details for Respreeza
NameRespreeza
Agency product numberEMEA/H/C/002739
Active substance

human alpha1-proteinase inhibitor

International non-proprietary name (INN) or common name

human alpha1-proteinase inhibitor

Therapeutic area Genetic Diseases, InbornLung Diseases
Anatomical therapeutic chemical (ATC) code B02AB02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Respreeza
Marketing-authorisation holder

CSL Behring GmbH

Revision2
Date of issue of marketing authorisation valid throughout the European Union20/08/2015

Contact address:

CSL Behring GmbH
Emil-von-Behring-Straße 76 
35041 Marburg 
Germany

Product information

Product information

13/10/2016  Respreeza -EMEA/H/C/002739 -N/0009

Name Language First published Last updated
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26
Respreeza : EPAR - Product Information EN = English 2015-09-16 2016-10-26

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
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  
Respreeza : EPAR - All Authorised presentations EN = English 2015-09-16  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Respreeza : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-10-03 2016-10-26

Initial marketing-authorisation documents

Name Language First published Last updated
Respreeza : EPAR - Public assessment report EN = English 2015-09-16  
CHMP summary of positive opinion for Respreeza EN = English 2015-06-26  

Authorised

This medicine is approved for use in the European Union