Overview

PRAXBIND® is a specific reversal agent for dabigatran. PRAXBIND® is indicated in adult patients treated with PRADAXA® when rapid reversal of the anticoagulant effects of dabigatran is required.

Product overview

PRAXBIND® is a specific reversal agent for PRADAXA®.

Product Key Facts

Indication

PRAXBIND® is a specific reversal agent for dabigatran and is indicated in adult patients treated with PRADAXA® when rapid reversal of the anticoagulant effects of dabigatran is required:

For emergency surgery/urgent procedures
In life-threatening or uncontrolled bleeding

Active ingredients

Idarucizumab

Legal category

Prescription only medicine

Administration form

Intravenous bolus or infusion

Dosage form

Solution for injection/infusion

Pack sizes

50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminum cap and a label with integrated hanger.
Pack size of 2 vials.

Storage

Store in a refrigerator (2 °C-8 °C).
Do not freeze.
Store in the original package in order to protect from light.

Prior to use, the unopened vial may be kept at room temperature (25 °C) for up to 48 hours, if stored in the original package in order to protect from light, or up to 6 hours when exposed to light.

Reference:

PRAXBIND® approved package insert. Updated in May 2019 and approved in November 2019.

PRAXBIND®