Difference between revisions of "Prothrombin Complex Concentrate, human"
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==General information== | ==General information== | ||
| − | Class/mechanism: Concentrate of vitamin K-dependent coagulation factors II (FII), VII (FVII), IX (FIX), X (FX), and protein C and protein S. Use of prothrombin complex concentrate can help control acute major bleeding that may result from acquired deficiency of vitamin K-dependent coagulation factors (supratherapeutic INR) in patients who are using vitamin K antagonists (VKA) such as [[Warfarin (Coumadin)]].<ref name="insert">[http://labeling.cslbehring.com/PI/US/Kcentra/EN/Kcentra-Prescribing-Information.pdf Prothrombin Complex Concentrate, Human (Kcentra) package insert]</ref><ref>[[File:Prothrombincomplexconcentrate.pdf | Prothrombin Complex Concentrate, Human (Kcentra) package insert (locally hosted backup)]]</ref><ref>[http://www.kcentra.com/ Kcentra manufacturer's website]</ref> | + | Class/mechanism: Concentrate of vitamin K-dependent coagulation factors II (FII), VII (FVII), IX (FIX), X (FX), and protein C and protein S. Use of prothrombin complex concentrate can help control acute major bleeding that may result from acquired deficiency of vitamin K-dependent coagulation factors (supratherapeutic INR) in patients who are using vitamin K antagonists (VKA) such as [[Warfarin (Coumadin)]].<ref name="insert">[http://labeling.cslbehring.com/PI/US/Kcentra/EN/Kcentra-Prescribing-Information.pdf Prothrombin Complex Concentrate, Human (Kcentra) package insert]</ref><ref>[[:File:Prothrombincomplexconcentrate.pdf | Prothrombin Complex Concentrate, Human (Kcentra) package insert (locally hosted backup)]]</ref><ref>[http://www.kcentra.com/ Kcentra manufacturer's website]</ref> |
| + | |||
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <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 such as | + | 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, [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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==Patient drug information== | ==Patient drug information== | ||
| − | * | + | *[http://labeling.cslbehring.com/PI/US/Kcentra/EN/Kcentra-Prescribing-Information.pdf#page=7 Prothrombin Complex Concentrate, Human (Kcentra) package insert]<ref name="insert"></ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2013-04-29: '''Kcentra''' approved for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. |
| + | *2023-07-25: '''Balfaxar''' approved for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. ''(Based on LEX-209)'' | ||
==Also known as== | ==Also known as== | ||
| − | *'''Generic names:''' 4-factor prothrombin complex concentrate, factor IX complex, PCC | + | *'''Generic names:''' 4-factor prothrombin complex concentrate, factor IX complex, PCC, prothrombin complex concentrate human-lans |
| − | *'''Brand names:''' Beriplex, Confidex, Kcentra, Octaplex, Profilnine | + | *'''Brand names:''' Balfaxar, Beriplex, Confidex, Kcentra, Octaplex, Profilnine |
==References== | ==References== | ||
Latest revision as of 11:55, 29 June 2024
General information
Class/mechanism: Concentrate of vitamin K-dependent coagulation factors II (FII), VII (FVII), IX (FIX), X (FX), and protein C and protein S. Use of prothrombin complex concentrate can help control acute major bleeding that may result from acquired deficiency of vitamin K-dependent coagulation factors (supratherapeutic INR) in patients who are using vitamin K antagonists (VKA) such as Warfarin (Coumadin).[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
Patient drug information
History of changes in FDA indication
- 2013-04-29: Kcentra approved for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.
- 2023-07-25: Balfaxar approved for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. (Based on LEX-209)
Also known as
- Generic names: 4-factor prothrombin complex concentrate, factor IX complex, PCC, prothrombin complex concentrate human-lans
- Brand names: Balfaxar, Beriplex, Confidex, Kcentra, Octaplex, Profilnine