Overview

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.

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.

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.

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.

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).

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.

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.

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 Praxbind : EPAR - Risk-management-plan summary.

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.

Praxbind : EPAR - Summary for the public

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Praxbind : EPAR - Risk-management-plan summary

Product information

Praxbind : EPAR - Product Information

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Latest procedure affecting product information: IB/0033

10/07/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Praxbind : EPAR - All Authorised presentations

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Product details

Name of medicine
Praxbind
Active substance
idarucizumab
International non-proprietary name (INN) or common name
idarucizumab
Therapeutic area (MeSH)
Hemorrhage
Anatomical therapeutic chemical (ATC) code
V03AB

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.

Authorisation details

EMA product number
EMEA/H/C/003986

Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Marketing authorisation holder
Boehringer Ingelheim International GmbH

Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Opinion adopted
24/09/2015
Marketing authorisation issued
20/11/2015
Revision
12

Assessment history

Praxbind : EPAR - Procedural steps taken and scientific information after authorisation

Praxbind : EPAR - Public assessment report

CHMP summary of positive opinion for Praxbind

Topics

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