- There are no targeted reversal agents for rivaroxaban in the context of peri-operative management. If patient requires urgent surgical or invasive procedure discussion with the surgical provider and Hematology is recommended. Determine if procedure can be delayed until 24 hours after rivaroxaban ingestion in patient with normal renal function or 48 hours after ingestion in patient with CrCl < 30 mL/min/1.73 m2.
- Andexanet alfa was previously the sole FDA-approved reversal agent for rivaroxaban. However, following its U.S. withdrawal in December 2025 due to an unfavorable risk-benefit profile (driven primarily by excess thromboembolic events), no targeted reversal agent for factor Xa inhibitors remains available in the U.S. Given the lack of a specific factor Xa inhibitor reversal agent – particularly for pediatric populations – clinicians must rely on off-label prothrombin complex concentrates (PCC) for severe bleeding or urgent procedures.
Kcentra (prothrombin complex concentrate) 25-50 units/kg/dose (maximum 2000 unit/dose) for severe bleeding or NovoSeven (rFVIIa) 90 mcg/kg may be considered. FEIBA (activated PCC) 50 units/kg would be a last resort due to higher thrombosis risk. They are on formulary at PMCH but are not labeled by the manufacturer for reversal of rivaroxaban.
In the setting of overdose, also consider administration of activated charcoal (50 g) if within 2 hours of dose.
Rivaroxaban is NOT dialyzable because it is mostly protein bound.
