Idarucizumab (Praxbind)

General information

Class/mechanism: Monoclonal antibody fragment (Fab) that binds to Dabigatran (Pradaxa) and its metabolites with higher affinity than dabigatran binds to thrombin, which neutralizes the anticoagulant effect of dabigatran.^[1]^[2]^[3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Bleeding with anticoagulation

Patient drug information

Idarucizumab (Praxbind) package insert^[1]

History of changes in FDA indication

2015-10-16: Approved in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

History of changes in PMDA indication

2016-09-28: New approval for the reversal of anticoagulant effect of dabigatran under the following situations: life-threatening or uncontrolled bleeding; and when performing emergency surgery or procedures in which serious bleeding is expected.

Also known as

Code name: BI-655075
Brand name: Praxbind

References

[insert-1] 1.0 ^1.1 ^1.2 Idarucizumab (Praxbind) package insert

[2] Idarucizumab (Praxbind) package insert (locally hosted backup)

[3] Praxbind manufacturer's website

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[2]

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