Praxbind - Idarucizumab

What is Praxbind - Idarucizumab used for and what is it used for?

Praxbind is a medicine used to neutralize the effects of dabigatran (the active substance in Pradaxa), a drug for the treatment and prevention of blood clots. Praxbind is used to quickly stop the anticoagulant effect of dabigatran, before an emergency surgery or in case of potentially fatal bleeding.

Praxbind contains the active ingredient idarucizumab.

How is Praxbind - Idarucizumab used?

Praxbind is available as a solution for injection or infusion (drip) into a vein. The recommended dose of Praxbind is 5 g administered intravenously via two injections or infusions, one after the other. If necessary, a second 5 g dose can be given via two injections or infusions.

The medicine can only be obtained with a prescription and is limited exclusively to hospital use

How does Praxbind - Idarucizumab work?

The active substance in Praxbind, idarucizumab, is a monoclonal antibody fragment. A monoclonal antibody is a type of protein designed to recognize and bind to a specific structure (called an antigen). Praxbind works by binding tightly to dabigatran and forming a complex in the blood. This quickly interrupts the anticoagulant effect of dabigatran.

What benefit has Praxbind - Idarucizumab shown during the studies?

Praxbind has been studied in three main studies involving 141 healthy adult patients who had previously taken dabigatran. In the studies, the volunteers received Praxbind or placebo (a dummy treatment) after being treated with Pradaxa for 3.5 days. The results showed that Praxbind was able to completely neutralize the anticoagulant effect of Pradaxa within 5 minutes of administration. As part of an ongoing trial, an interim analysis showed similar results on 123 patients who had uncontrolled bleeding or who needed emergency surgery and who were on therapy with Pradaxa. Most of the patients in the study were taking Pradaxa to prevent the risk of stroke due to an "abnormal heart rate" (atrial fibrillation).

What is the risk associated with Praxbind - Idarucizumab?

At the time of authorization, Praxbind was not associated with any particular side effects.

For information on the limitations of Praxbind, see the package leaflet.

Why has Praxbind - Idarucizumab been approved?

The main studies have shown that Praxbind is effective in neutralizing the effects of Pradaxa and that its action is rapid, complete and constant. The magnitude of Praxbind's benefits depends on the patient's general health, severity and bleeding site. No undesirable effects have been identified. The Agency's Committee for Medicinal Products for Human Use (CHMP) 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 - Idarucizumab?

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.