Rivaroxaban (Xarelto)

General information

Class/mechanism: Factor Xa inhibitor, acts at the active site of factor Xa to inhibit its actions in the coagulation cascade.
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.

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
• Rivaroxaban (Xarelto) patient drug information (UpToDate)

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