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XARELTO®

(rivaroxaban)

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XARELTO® (rivaroxaban)

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SPECIFIC RESPONSE

XARELTO - Summary Tables - rFVIIa

Last updated : 05/16/2024

Summary of Studies Assessing Reversal Agents for XARELTO: rFVIIaa

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Study

Agent Used

Type of Study

Results

Perzborn et al (2014)1

NovoSeven® (5-50 µg/mL)

In vitro

  • Reduced PT
  • Decreased CT
  • Reduced LT
  • Increased ETP-AUC
  • Corrected TP

Arellano-Rodrigo et al (2015)2

NovoSeven® (270 µg/kg)

Ex vivo

  • Decreased CT
  • Increased clot firmness
  • Improved fibrin formation

Escolar et al (2015)3

NovoSeven® (270 µg/kg)

Humans
  • Decreased CT
  • Increased clot firmness
  • Restored fibrin formation

Perzborn et al (2013)4

NovoSeven®

Animals
(rats and baboons)
  • Reduced PT
  • Reduced BT

Zhou et al (2013)5

NovoSeven®

Animals (mice)
  • Reduced PT
  • Corrected deficiency of factor II and factor X

Marlu et al (2012)6

NovoSeven®

Ex vivo

  • Reduced LT
  • Increased thrombin generation
  • Decreased TTP

Godier et al (2012)7

rFVIIa

Animals (rabbits)
  • Decreased CT
  • Reduced aPTT

aNot all studies from this table are summarized in the response. Kindly refer to the hyperlinked reference for the full publication.
aPTT, activated partial thromboplastin time; BT, bleeding time; CT, clotting time; ETP, endogenous thrombin potential; LT, lag time; PT, prothrombin time; rFVIIa, recombinant factor VIIa; TP, thrombin peak; TTP, time to reach maximum thrombin concentration.

References

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1. Perzborn E, Heitmeier S, Laux V, et al. Reversal of rivaroxaban-induced anticoagulation with prothrombin complex concentrate, activated prothrombin complex concentrate and recombinant activated factor VII in vitro. Thromb Res. 2014;133(4):671-681.

2. Arellano-Rodrigo E, Lopez-Vilchez I, Galan AM, et al. Coagulation factor concentrates fail to restore alterations in fibrin formation caused by rivaroxaban or dabigatran in studies with flowing blood from treated healthy volunteers. Transfus Med Rev. 2015;29(4):242-249.

3. Escolar G, Arellano-Rodrigo E, Lopez-Vilchez I, et al. Reversal of rivaroxaban-induced alterations on hemostasis by different coagulation factor concentrates – in vitro studies with steady and circulating human blood. Circ J. 2015;79(2):331-338.

4. Perzborn E, Gruber A, Tinel H, et al. Reversal of rivaroxaban anticoagulation by haemostatic agents in rats and primates. Thromb Haemost. 2013;110(1)162-172.

5. Zhou W, Zorn M, Nawroth P, et al. Hemostatic therapy in experimental intracerebral hemorrhage associated with rivaroxaban. Stroke. 2013;44(3):771-778.

6. Marlu R, Hodaj E, Paris A, et al. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers. Thromb Haemost. 2012;108(2):217-224.

7. Godier A, Miclot A, Le Bonniec, B, et al. Evaluation of prothrombin complex concentrate and recombinant activated factor VII to reverse rivaroxaban in a rabbit model. Anesthesiology. 2012;116(1):94-102.