Difference between revisions of "Idarucizumab (Praxbind)"
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| − | = | + | ==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.<ref name=insert>[http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Praxbind/Praxbind.pdf Idarucizumab (Praxbind) package insert]</ref><ref>[[:File:Idarucizumab.pdf | Idarucizumab (Praxbind) package insert (locally hosted backup)]]</ref><ref>[http://www.praxbind.com/ Praxbind manufacturer's website]</ref> | |
| + | <br>Route: IV | ||
| + | <br>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 or the prescribing information.<ref name="insert"></ref> | |
| − | + | ||
| + | ==Diseases for which it is used== | ||
| + | *[[Bleeding with anticoagulation]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Praxbind/Praxbind.pdf Idarucizumab (Praxbind) package insert]<ref name="insert"></ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2015-10-16: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm Approved] in patients treated with [[Dabigatran (Pradaxa) | Pradaxa]] when reversal of the anticoagulant effects of [[Dabigatran (Pradaxa) | 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== | ||
| + | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Intravenous medications]] | ||
| + | [[Category:Anti-dabigatran antibody fragments]] | ||
| − | |||
[[Category:Hematology medications]] | [[Category:Hematology medications]] | ||
| − | [[Category: | + | [[Category:Hemostasis medications]] |
| + | [[Category:FDA approved in 2015]] | ||
| + | [[Category:PMDA approved in 2016]] | ||
Latest revision as of 00:58, 29 June 2024
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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
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