Xarelto

Xarelto Overdosage

rivaroxaban

Manufacturer:

Bayer

Distributor:

Bayer
Full Prescribing Info
Overdosage
Rare cases of overdose up to 600 mg have been reported without bleeding complications or other adverse reactions. Due to limited absorption a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50 mg or above.
A specific antidote antagonizing the pharmacodynamic effect of rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of Rivaroxaban (Xarelto) overdose may be considered. Due to the high plasma protein binding rivaroxaban is not expected to be dialyzable.
Management of Bleeding: Should a bleeding complication arise in a patient receiving rivaroxaban, the next administration should be delayed or treatment should be discontinued as appropriate. Rivaroxaban has a half-life of approximately 5 to 13 hours. Management should be individualized according to the severity and location of the hemorrhage. Appropriate symptomatic treatment could be used as needed, such as mechanical compression (e.g., for severe epistaxis), surgical hemostasis with bleeding control procedures, fluid replacement and hemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anemia or coagulopathy) or platelets.
If bleeding cannot be controlled by the previous measures, administration of a specific procoagulant reversal agent should be considered, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (APCC), or recombinant factor VIIa (r-FVIIa). However, there is currently very limited clinical experience with the use of these products in individuals receiving Rivaroxaban (Xarelto) (see Pharmacology: Pharmacodynamics under Actions).
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban.
There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving Rivaroxaban (Xarelto). There is neither scientific rationale for benefit nor experience with the systemic hemostatic desmopressin in individuals receiving Rivaroxaban (Xarelto).
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