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XARELTO®

(rivaroxaban)

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XARELTO® (rivaroxaban)

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SPECIFIC RESPONSE

XARELTO - Summary Tables - PCC

Last updated : 05/16/2024

Summary of Studies Assessing Reversal Agents for XARELTO: PCCa

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Study

Agent Used

Type of Study

Results

Rayatdoost et al (2024)1

Cofact®, Beriplex®, Octaplex®, and Prothromplex

Humans
  • Reduced PT and partial reversal of anticoagulant effects

Levi et al (2014)2

Profilnine SD® 50 IU/kg
(3-factor PCC)

Humans
  • Reduced PT
  • Increase in thrombin generation
  • Increased ETP-AUC

Beriplex® 50 IU/kg
(4-factor PCC)

Humans
  • Reduced PT
  • Increased ETP-AUC

Marlu et al (2012)3

Kanokad® (4-factor PCC)

ex vivo
  • Increased ETP-AUC
  • Reduced LT
  • Corrected thrombin peak

Eerenberg et al (2011)4

Cofact® 50 IU/kg
(nonactivated PCC)

Humans
  • Reduced PT
  • Increased ETP-AUC

Arellano-Rodrigo et al (2015)5

Beriplex® 50 IU/kg
(4-factor PCC)

ex vivo
  • Decreased CT
  • Increased clot firmness
  • Improved fibrin formation

Escolar et al (2015)6

Beriplex® 50 IU/kg
(4-factor PCC)

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

Schulman et al (2018)7

Octaplex®, Beriplex®

Humans
  • Effectiveness ratings of good, moderate, and poor/none in 65%, 20%, and 15% of patients, respectively

Perzborn et al (2014)8

Beriplex P/N®
(4-factor PCC)

in vitro
  • Reduced PT
  • Increased ETP-AUC
  • Corrected thrombin peak

Perzborn et al (2013)9

Beriplex P/N®
(4-factor PCC)

Animals
(rats and baboons)
  • Reduced BT
  • Increased thrombin generation

Zhou et al (2013)10

Beriplex P/N®
(4-factor PCC)

Animals (mice)
  • Reduced hematoma size
  • Increased plasma activities of all factors except FVII

Godier et al (2012)11

Kaskadil® (4-factor PCC)

Animals (rabbits)
  • Decreased CT
  • Decreased aPTT

Herzog et al (2015)12

Beriplex®, K-Centra®
(4‑factor PCC)

Animals (rabbits)
  • Decreased time to hemostasis
  • Decreased blood loss

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; AUC, area under the curve; BT, bleeding time; CT, clotting time; ETP, endogenous thrombin potential; FVII, factor VII; LT, lag time; PCC, prothrombin complex concentrate; PT, prothrombin time.

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. Levi M, Moore K, Castillejos C, et al. Comparison of three-factor and four-factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers. J Thromb Haemost. 2014;12(9):1428-1436.

3. 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.

4. Eerenberg ES, Kamphuisen PW, Sijpkens MK, et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011;124(14):1573-1579.

5. 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.

6. 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.

7. Schulman S, Gross PL, Ritchie B, et al. Prothrombin complex concentrate for major bleeding on factor Xa inhibitors: a prospective cohort study. Thromb Haemost. 2018;118(5):842-851.

8. 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.

9. 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.

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

11. 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.

12. Herzog E, Kaspereit F, Krege W, et al. Correlation of coagulation markers and 4F-PCC-mediated reversal of rivaroxaban in a rabbit model of acute bleeding. Thromb Res. 2015;135(3):554-560.