Janssen announced that a type of medication called prothrombin complex concentrates (PCCs) can reverse the anticoagulant effects of Xarelto (rivaroxaban) in healthy subjects. These findings from an open-label, single-center, parallel group study were presented at the International Society on Thrombosis and Haemostasis Annual Meeting.
The study evaluated three- and four-factor PCCs in healthy adults (N=34) treated with Xarelto 20mg twice daily for four days. On the fifth day, patients received either a 50 IU/kg single IV bolus of three-factor PCC (Profilnine SD; Grifols Biologicals), four-factor PCC (Beriplex P/N), or a 100mL single bolus of saline.
Both three- and four-factor PCCs were found to partially reverse the Xarelto-induced prolongation of the prothrombin time (PT) – the time it takes the blood to clot – in healthy subjects, with the latter reducing the mean PT by 2.5 to 3.5 seconds (versus a 0.6 to 1.0 second reduction associated with three-factor PCC). Conversely, three-factor PCC had a greater effect on the reversal of Xarelto-induced changes in endogenous thrombin potential (ETP) – the total amount of thrombin generated during the test – than four-factor PCC.
Currently, there is no approved reversal agent for Xarelto. Janssen, in collaboration with Portola and Bayer, is evaluating the safety of PRT4445, an investigational-stage antidote for Factor Xa inhibitors, and its ability to reverse the anticoagulant activity of Xarelto in emergency situations.
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