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XARELTO®

(rivaroxaban)

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XARELTO - Summary Tables - aPCC

Last updated : 05/16/2024

Summary of Studies Assessing Reversal Agents for XARELTO: aPCCa

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Study

Agent Used

Type of Study

Results

FEIBA

Humans

  • Reduced PT
  • Reduced aPTT prolongation

FEIBA

Humans

  • Of 52 patients, 39 (75%) achieved clinical hemostasis

FEIBA NF®

In vitro

  • Reduced PT
  • Decreased CT
  • Reduced LT
  • Increased ETP-AUC
  • Corrected thrombin peak

Arellano-Rodrigo et al (2015)4

FEIBA 75 U/kg

Ex vivo

  • Decreased CT
  • Increased clot firmness
  • Improved fibrin formation

FEIBA 75 IU/kg

Humans

  • Decreased CT
  • Increased clot firmness
  • Restored fibrin formation

Perzborn et al (2013)6

FEIBA VH®

Animals
(rats and baboons)

  • Reduced PT
  • Reduced BT
  • Increased thrombin generation
  • Increase in TAT

Marlu et al (2012)7

FEIBA

Ex vivo

  • Increased ETP-AUC
  • Corrected TP
  • Decreased TTP

aNot all studies from this table are summarized in the response. Kindly refer to the hyperlinked reference for the full publication.
aPCC, activated prothrombin complex concentrate; aPTT, activated partial thromboplastin time; AUC, area under the curve; BT, bleeding time; CT, clotting time; ETP, endogenous thrombin potential; LT, lag time; PT, prothrombin time; TAT, thrombin-antithrombin complex; TP, thrombin peak; TTP, time to reach maximum thrombin concentration.

References

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1. Rayatdoost F, Deventer K, Rossaint R, et al. Comparative analysis of andexanet alfa and prothrombin complex concentrate in reversing anticoagulation by rivaroxaban ex vivo. Br J Anaesth. 2024;132(2):251-259.

2. Sheikh-Taha M, Clark HL, Crawley RM. Efficacy and safety of activated prothrombin complex concentrate for reversal of the anticoagulant effect of apixaban and rivaroxaban in patients with major bleeding. Clin Drug Investig. 2023;43(11):883-888.

3. 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.

4. 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.

5. 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

6. 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.

7. 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.