Praxbind

idarucizumab

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

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

What is Praxbind and what is it used for?

Praxbind is a medicine used to neutralise the effects of dabigatran (the active substance of Pradaxa), a medicine that treats and prevents blood clots. Praxbind is used to rapidly stop the anticlotting effect of dabigatran, before emergency surgery or in case of life-threatening bleeding.

Praxbind contains the active substance idarucizumab.

How is Praxbind used?

Praxbind is available as a solution for injection or infusion (drip) into a vein. The recommended dose of Praxbind is 5 g given into a vein as two injections or infusions, one after the other. A second 5-g dose may be given as two further injections or infusions, if needed.

The medicine can only be obtained with a prescription and it is for use in hospital only.

How does Praxbind work?

The active substance in Praxbind, idarucizumab, is a monoclonal antibody fragment. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Praxbind works by attaching firmly to dabigatran, and forming a complex in the blood. This rapidly stops dabigatran’s anticlotting effect.

What benefits of Praxbind have been shown in studies?

Praxbind has been investigated in three main studies involving 141 healthy adults who previously received dabigatran. In the studies, volunteers received either Praxbind or placebo (a dummy treatment) after treatment with Pradaxa for 3.5 days. Results showed that Praxbind was able to completely neutralise Pradaxa's anticlotting effect within 5 minutes of use. In a still ongoing trial, an interim analysis showed similar results in 123 patients who had uncontrolled bleeding or required emergency surgery while using Pradaxa. Most patients in the study were taking Pradaxa to prevent stroke due to an ‘abnormal heart beat’ (atrial fibrillation).

What are the risks associated with Praxbind?

At the time of authorisation Praxbind has not been associated with any specific side effects.

For the information on the restrictions with Praxbind, see the package leaflet.

Why is Praxbind approved?

The main studies showed that Praxbind is effective at neutralising the effects of Pradaxa, and its action is rapid, complete and sustained. The extent of Praxbind’s benefit depends on the patient’s overall health, the severity of bleeding and the location of bleeding. No side effects have been identified. The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Praxbind’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 Praxbind?

A risk management plan has been developed to ensure that Praxbind is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Praxbind, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Praxbind

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

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

Name Language First published Last updated
Praxbind : EPAR - Summary for the public BG = bălgarski 01/12/2015  
Praxbind : EPAR - Summary for the public ES = español 01/12/2015  
Praxbind : EPAR - Summary for the public CS = čeština 01/12/2015  
Praxbind : EPAR - Summary for the public DA = dansk 01/12/2015  
Praxbind : EPAR - Summary for the public DE = Deutsch 01/12/2015  
Praxbind : EPAR - Summary for the public ET = eesti keel 01/12/2015  
Praxbind : EPAR - Summary for the public EL = elliniká 01/12/2015  
Praxbind : EPAR - Summary for the public EN = English 01/12/2015  
Praxbind : EPAR - Summary for the public FR = français 01/12/2015  
Praxbind : EPAR - Summary for the public IT = italiano 01/12/2015  
Praxbind : EPAR - Summary for the public LV = latviešu valoda 01/12/2015  
Praxbind : EPAR - Summary for the public LT = lietuvių kalba 01/12/2015  
Praxbind : EPAR - Summary for the public HU = magyar 01/12/2015  
Praxbind : EPAR - Summary for the public MT = Malti 01/12/2015  
Praxbind : EPAR - Summary for the public NL = Nederlands 01/12/2015  
Praxbind : EPAR - Summary for the public PL = polski 01/12/2015  
Praxbind : EPAR - Summary for the public PT = português 01/12/2015  
Praxbind : EPAR - Summary for the public RO = română 01/12/2015  
Praxbind : EPAR - Summary for the public SK = slovenčina 01/12/2015  
Praxbind : EPAR - Summary for the public SL = slovenščina 01/12/2015  
Praxbind : EPAR - Summary for the public FI = suomi 01/12/2015  
Praxbind : EPAR - Summary for the public SV = svenska 01/12/2015  
Praxbind : EPAR - Summary for the public HR = Hrvatski 01/12/2015  
Name Language First published Last updated
Praxbind : EPAR - Risk-management-plan summary (English only) 01/12/2015  

This EPAR was last updated on 01/12/2015 .

Authorisation details

Product details

Product details for Praxbind
NamePraxbind
Agency product numberEMEA/H/C/003986
Active substance

idarucizumab

International non-proprietary name (INN) or common name

idarucizumab

Therapeutic area Hemorrhage
Anatomical therapeutic chemical (ATC) code V03AB
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 Praxbind
Marketing-authorisation holder

Boehringer Ingelheim International GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union20/11/2015

Contact address:

Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Product information

Product information

20/11/2015  Praxbind -EMEA/H/C/003986 --

Name Language First published Last updated
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  
Praxbind : EPAR - Product Information EN = English 01/12/2015  

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
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  
Praxbind : EPAR - All Authorised presentations EN = English 01/12/2015  

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:

  • for emergency surgery/urgent procedures;
  • in life-threatening or uncontrolled bleeding.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Praxbind : EPAR - Public assessment report EN = English 01/12/2015  
CHMP summary of positive opinion for Praxbind EN = English 25/09/2015