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XARELTO®

(rivaroxaban)

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XARELTO® (rivaroxaban)

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SPECIFIC RESPONSE

XARELTO - Summary Tables - Andexanet alfa and Other Reversal Agents

Last updated : 05/16/2024

Summary of Studies Assessing Reversal Agents for XARELTO: Andexanet alfa and Other Reversal Agentsa

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Study

Agent Used

Type of Study

Results

Rayatdoost et al (2024)1

Andexanet alfa

Humans
  • Reduced PT
  • Reversed aPTT prolongation
  • Increased ETP

Siegal et al (2015)2

Andexanet alfa

Humans
  • Reduced anti–factor Xa activity
  • Reduced free XARELTO levels
  • Increased thrombin generation
  • Normalization of coagulation parameters

Crowther et al (2013)3

Andexanet alfa

Humans
  • Reduced anti–factor Xa activity
  • Reduced free XARELTO levels
  • Increased thrombin generation
  • Reduced PT
  • Reduced ACT

Lu et al (2013)4

Andexanet alfa

Animals
(rats, mice, rabbits)
  • Reduced blood loss
  • Reduced anti–factor Xa activity
  • Reduced free XARELTO levels
  • Reduced PT
  • Reduced aPTT

In vitro

  • Reduced PT

He et al (2013)5

Fibrinogen concentrate
(Haemocomplettan®)

In vitro

  • Lowered fibrin network permeability
  • Tighter fibrin network structure
  • Increased fibrin fiber numbers

Factor XIII concentrate
(Fibrogammin®)
  • Lowered fibrin network permeability
  • Increased clot lysis time

Zhou et al (2013)6

Murine FFP

Animals (mice)
  • Corrected deficiency of factor II and factor X
  • Elevation in proteins C and S activity

Milling et al (2023)7

Andexanet alfa

Humans
  • Reduced anti–factor Xa activity

aNot all studies from this table are summarized in the response. Kindly refer to the hyperlinked reference for the full publication.
ACT, activated clotting time; aPTT, activated partial thromboplastin time; ETP, endogenous thrombin potential; FFP, fresh frozen plasma; 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. Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. 2015;373(25):2413-2424.

3. Crowther M, Mathur V, Kitt M, et al. A phase 2 randomized, double-blind, placebo-controlled trial demonstrating reversal of rivaroxaban-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), an antidote for FXa inhibitors. Poster presented at: The 55th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2013; New Orleans, LA.

4. Lu G, Deguzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med. 2013;19(4):446-451.

5. He S, Johnsson H, Zabczyk M, et al. A fibrinogen concentrate Haemocomplettan (Riastap) or a Factor XIII concentrate Fibrogammin combined with a mini dose of tranexamic acid can reverse the fibrin instability to fibrinolysis induced by thrombin- or FXa-inhibitor. Br J Haematol. 2013;160(6):806-816.

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

7. Milling TJ Jr, Middeldorp S, Xu L, et al. Final Study Report of andexanet alfa for major bleeding with factor Xa inhibitors. Circulation. 2023;147(13):1026-1038