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A comparative in vitro study of the coagulation effects of branded versus generic preparations of rivaroxaban

1University of Malta, Kirkop, Malta, 2Mater Dei Hospital, Department of Pathology, Msida, Malta, Msida, Not Applicable, Malta, 3Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Not Applicable, Malta, 4National Blood Transfusion Service & Mater Dei Hospital Blood Bank, Msida, Not Applicable, Malta, 5Faculty of Medicine and Surgery, University of Malta, Msida, Malta

Abstract Number: PB1086

Meeting: ISTH 2022 Congress

Theme: Diagnostics and OMICs » Laboratory Diagnostics

Background: During the last few years, several generic versions of rivaroxaban were approved to be used interchangeably with their branded equivalent Xarelto®. However, there were no previous studies in the literature that directly compared the anticoagulant effects of branded and generic preparations of rivaroxaban on different coagulation assays.

Aims: The main aim of this in vitro study was to compare the anticoagulant effects of Xarelto® with two generic versions (Rivaroxaban Sandoz® and Rivarolto®) on a panel of coagulation assays.

Methods: The study was performed by first pooling normal plasma and spiking with different concentrations of the branded type and the two generic versions of rivaroxaban (concentration range 50 -1000 ng/ml). Several coagulation assays were performed: Prothrombin time (PT), activated Partial Thromboplastin time (aPTT), Thrombin time (TT), Clauss Fibrinogen, Diluted Russell’s Viper Venom Test (dRVVT), Factor VII one-stage assay, Factor VIII assays (one-stage & chromogenic), Factor IX assays (one-stage & chromogenic). The Pearson’s correlation test was utilized to check for correlation between the concentrations of the three different preparations of rivaroxaban and the selected assays. The One-Way ANOVA test was utilized to identify any variabilities in their action on the selected assays.

Results: There was a positive correlation between the concentrations of the three preparations of rivaroxaban and PT, aPTT and dRVVT (Pearson’s r > 0.93, p < 0.05 for all). There was a negative correlation between the concentrations of the three preparations and the one-stage and chromogenic factor assays (Pearson's r < - 0.83, p < 0.05 for all). TT did not correlate with any of the preparations (Table). No significant difference was identified in the anticoagulant effect of the three rivaroxaban formulations (p > 0.05 for all).

Conclusion(s): This study showed that the generic versions of rivaroxaban do not exert any different in vitro anticoagulant effect from Xarelto® on several coagulation assays.

Table

Table: Correlation between the concentrations of the three preparations of rivaroxaban with several Coagulation assays

To cite this abstract in AMA style:

Mangion K, Vella K, Gatt A, Borg Aquilina D, Riva N. A comparative in vitro study of the coagulation effects of branded versus generic preparations of rivaroxaban [abstract]. https://abstracts.isth.org/abstract/a-comparative-in-vitro-study-of-the-coagulation-effects-of-branded-versus-generic-preparations-of-rivaroxaban/. Accessed December 6, 2023.

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