Difference between revisions of "Rivaroxaban (Xarelto)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Factor Xa inhibitor, acts at the active site of factor Xa to inhibit its actions in the coagulation cascade.<ref name="insert">[ | + | Class/mechanism: Factor Xa inhibitor, acts at the active site of factor Xa to inhibit its actions in the coagulation cascade.<ref name="insert">[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf Rivaroxaban (Xarelto) package insert]</ref><ref>[[:File:Rivaroxaban.pdf | Rivaroxaban (Xarelto) package insert (locally hosted backup)]]</ref><ref>[http://www.xarelto.com Xarelto manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
| + | |||
| + | ==Reversal information== | ||
| + | [[Andexanet alfa (Andexxa)]] can bind, sequester, and reverse the anticoagulation effect of [[Rivaroxaban (Xarelto)|rivaroxaban]] and [[Apixaban (Eliquis)|apixaban]]. | ||
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *Atrial fibrillation | ||
| + | *[[Venous thromboembolism]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf Rivaroxaban (Xarelto) package insert]<ref name="insert"></ref> |
*[http://www.uptodate.com/contents/rivaroxaban-patient-drug-information Rivaroxaban (Xarelto) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/rivaroxaban-patient-drug-information Rivaroxaban (Xarelto) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/rivaroxaban-patient-drug-information Rivaroxaban (Xarelto) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/rivaroxaban-patient-drug-information Rivaroxaban (Xarelto) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2011-07-01: Approved for the prophylaxis of [[Venous thromboembolism|DVT]], which may lead to PE in patients undergoing knee or hip replacement surgery. |
| − | *11 | + | *2011-11-04: Approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ''(Non-hematologic indication)'' |
| − | *11 | + | *2012-11-02: Approved for the treatment of [[Venous thromboembolism|deep vein thrombosis (DVT), pulmonary embolism (PE)]], and for the reduction in the risk of recurrence of DVT and of PE. |
| + | ==History of changes in EMA indication== | ||
| + | *2008-09-30: Initial authorization | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2015-09-24: New additional indication and a new dosage for the treatment and prevention of recurrence of [[venous thromboembolism|deep vein thrombosis and pulmonary thromboembolism]]. | ||
| + | *2021-01-22: New indication and a new additional pediatric dosage for the treatment and prevention of recurrent [[venous thromboembolism]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' BAY 59-7939 | + | *'''Code name:''' BAY-59-7939 |
*'''Brand name:''' Xarelto | *'''Brand name:''' Xarelto | ||
| Line 22: | Line 34: | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| + | [[Category:Direct oral anticoagulants]] | ||
[[Category:Factor Xa inhibitors]] | [[Category:Factor Xa inhibitors]] | ||
| − | [[Category: | + | [[Category:Heparin-induced thrombocytopenia medications]] |
| − | [[Category: | + | [[Category:Venous thromboembolism medications]] |
| − | [[Category: | + | |
| + | [[Category:EMA approved in 2008]] | ||
| + | [[Category:FDA approved in 2011]] | ||
Latest revision as of 12:00, 19 August 2023
General information
Class/mechanism: Factor Xa inhibitor, acts at the active site of factor Xa to inhibit its actions in the coagulation cascade.[1][2][3]
Route: PO
Extravasation: n/a
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]
Reversal information
Andexanet alfa (Andexxa) can bind, sequester, and reverse the anticoagulation effect of rivaroxaban and apixaban.
Diseases for which it is used
- Atrial fibrillation
- Venous thromboembolism
Patient drug information
- Rivaroxaban (Xarelto) package insert[1]
- Rivaroxaban (Xarelto) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2011-07-01: Approved for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
- 2011-11-04: Approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (Non-hematologic indication)
- 2012-11-02: Approved for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE.
History of changes in EMA indication
- 2008-09-30: Initial authorization
History of changes in PMDA indication
- 2015-09-24: New additional indication and a new dosage for the treatment and prevention of recurrence of deep vein thrombosis and pulmonary thromboembolism.
- 2021-01-22: New indication and a new additional pediatric dosage for the treatment and prevention of recurrent venous thromboembolism.
Also known as
- Code name: BAY-59-7939
- Brand name: Xarelto