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idarucizumab (Praxbind)

Advice

following a full submission:

idarucizumab (Praxbind®) is accepted for use within NHS Scotland.

Indication under review: idarucizumab is a specific reversal agent for dabigatran and is indicated in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

In a phase III, non-randomised, case series study, treatment with idarucizumab reversed the effect of dabigatran, with a median maximum percentage reversal of 100%.

Drug Details

Drug Name: idarucizumab (Praxbind)
SMC Drug ID: 1178/16
Manufacturer: Boehringer Ingelheim Ltd
Indication: Idarucizumab is a specific reversal agent for dabigatran and is indicated in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
BNF Category:
Sub Category: 2.8 Anticoagulants and protamine
Submission Type: Full submission
Status: Accepted
Date Advice Published: 12 September 2016

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