Overdose of apixaban may result in a higher risk of bleeding. In the event of haemorrhagic complications, treatment must be discontinued, and the source of bleeding investigated. The initiation of appropriate treatment, e.g. surgical haemostasis, the transfusion of fresh frozen plasma, or the administration of a reversal agent for factor Xa inhibitors should be considered.
In controlled clinical studies, orally-administered apixaban in healthy subjects at doses up to 50 mg daily for
In healthy subjects, administration of activated charcoal 2 and 6 hours after ingestion of a 20 mg dose of apixaban reduced mean AUC by 50% and 27%, respectively, and had no impact on Cmax. Mean half-life decreased from 13.4 hours when apixaban was administered alone to 5.3 hours and 4.9 hours, respectively, when activated charcoal was administered 2 and 6 hours after apixaban. Thus, administration of activated charcoal may be useful in the management of apixaban overdose or accidental ingestion.
For situations when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, a reversal agent for factor Xa inhibitors is available. Administration of prothrombin complex concentrates (PCCs) or recombinant factor VIIa may also be considered. Reversal of apixaban pharmacodynamic effects, as demonstrated by changes in the thrombin generation assay, was evident at the end of infusion and reached baseline values within
Depending on local availability, consultation of a coagulation expert should be considered in case of major bleeding.
This Prescriber Guide is not a substitute for the apixaban Summary of Product Characteristics (SmPC). Please consult the SmPC for full prescribing information.