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Class: Antihemorrhagic Agents, Miscellaneous
Chemical Name: Anti-(dabigatran) (human-Mus musculus κ-chain), anti-(dabigatran) (human-Mus musculus γ1-chain) (225→219′)-disulfide with immunoglobulin G1, 1-225-immunoglobulin G1
Molecular Formula: C2131H3299N555O671S11
CAS Number: 1362509-93-0
Brands: Praxbind

Medically reviewed by Last updated on Oct 14, 2019.


Specific reversal agent for anticoagulant effects of dabigatran etexilate mesylate (Pradaxa); recombinant humanized monoclonal antibody fragment capable of binding dabigatran.1 8 16

Uses for Idarucizumab

Urgent Reversal of Dabigatran Anticoagulation

Used for the urgent reversal of dabigatran anticoagulation in patients with life-threatening or uncontrolled bleeding or a need for emergency surgery/urgent procedures; designated an orphan drug by FDA for this use.1 2 3

Accelerated approval of idarucizumab for this indication based on reduction in unbound plasma dabigatran and normalization of coagulation parameters with idarucizumab treatment in healthy individuals; continued FDA approval for this indication may be contingent on results of ongoing cohort case series study.1 6

Specifically reverses dabigatran-induced anticoagulation; no impact on the effect of other anticoagulant or antithrombotic therapies.1 7 16

Some experts state that reversal agents such as idarucizumab should be used sparingly and generally reserved for patients with severe and life-threatening bleeding or those who must undergo an urgent procedure that requires immediate reversal of anticoagulation.25 26 27

Can be used in conjunction with supportive measures (e.g., maintenance of adequate diuresis, mechanical compression, surgical hemostasis, volume replacement, blood products) as appropriate.1 17 18

Idarucizumab Dosage and Administration


  • Dabigatran therapy can be reinitiated 24 hours after administration of idarucizumab; consider resumption of anticoagulation as soon as medically appropriate.1 7 16 (See Thromboembolic Complications under Cautions.)


IV Administration

Administer as 2 consecutive IV infusions directly from 50-mL vials of idarucizumab or as 2 consecutive rapid IV (“bolus”) injections via syringe; administer undiluted.1 13

Once idarucizumab is withdrawn from vial, begin administration promptly or within 1 hour.1

Do not mix or administer with any other drug.1

May be administered through existing IV line; flush line with 0.9% sodium chloride injection prior to and at the end of idarucizumab infusion.1 19

Rate of Administration

IV infusion and rapid IV injection: Administer as rapidly as clinically feasible.19 Some clinicians state that infusion of each vial via syringe, infusion pump, or other appropriate equipment should take no longer than 5–10 minutes.16



Urgent Reversal of Dabigatran Anticoagulation

5 g administered in 2 divided (2.5 g each) consecutive doses via IV infusion or rapid IV injection.1 16

If reappearance of clinically relevant bleeding and elevated coagulation parameters occur or patient requires second emergency surgery/urgent procedure and has elevated coagulation parameters, may administer additional 5-g dose.1 16 Safety and efficacy of repeat treatment with idarucizumab not established.1

Special Populations

Renal Impairment

Dosage adjustment not required.1 13

Hepatic Impairment

Safety and efficacy not established. 1 13

Cautions for Idarucizumab


  • Manufacturer states none.1


Thromboembolic Complications

Patients receiving therapy with dabigatran usually have underlying conditions that predispose them to thromboembolism; reversal of anticoagulation by idarucizumab exposes patients to their underlying thrombotic risk.1 12 Consider resumption of anticoagulant therapy as soon as medically appropriate.1

Hereditary Fructose Intolerance

Recommended 5-g dose of idarucizumab contains 4 g of sorbitol as an excipient.1

Serious adverse reactions, including death, reported in patients with hereditary fructose intolerance who received parenteral sorbitol.1 Minimum amount of sorbitol at which serious adverse reactions may occur in such patients not known.1


Potential for immunogenicity with use of all therapeutic proteins, including idarucizumab.1 16 Preexisting antibodies with cross-reactivity to idarucizumab detected in some patients in clinical trials; however, clinically important effects not observed.1 5 7

Sensitivity Reactions


Additional clinical experience needed to fully determine immunogenic risk.1 Adverse events possibly indicative of hypersensitivity reactions (e.g., pyrexia, bronchospasm, rash, pruritus) reported.1

Weigh anticipated benefits of idarucizumab against risk of hypersensitivity in patients with known hypersensitivity (e.g., anaphylactoid reaction) to idarucizumab or other ingredients in formulation.1 Discontinue idarucizumab and initiate appropriate therapy if severe hypersensitivity reaction occurs.1

Specific Populations


No adequate and well-controlled studies of idarucizumab in pregnant women.1 13 Animal reproductive and developmental studies with idarucizumab lacking.1 Use during pregnancy only when clearly needed.1 Safety and efficacy of idarucizumab during labor and delivery not established.1


Not known whether idarucizumab is distributed into human milk.1 Use with caution.1

Pediatric Use

Safety and efficacy not established.1 12

Geriatric Use

No overall differences in efficacy or safety between geriatric and younger patients; however, increased sensitivity of some older individuals cannot be ruled out.1 12

Renal Impairment

Does not affect dabigatran anticoagulation reversal effect of idarucizumab.1 13

Hepatic Impairment

Pharmacokinetic data lacking.1 13

Common Adverse Effects

Headache,1 hypokalemia,1 14 delirium,1 14 constipation,1 14 pyrexia.1 14

Interactions for Idarucizumab

Specific Drugs



Coagulation factor concentrates (3- or 4- factor prothrombin complex concentrates [PCC], activated PCC, recombinant factor VIIa)

Inhibition of dabigatran anticoagulation not affected1

Volume-replacement preparations (crystalloids, colloids)

Neutralization of dabigatran not influenced by 50% hemodilution with volume-replacement therapies1 7 8

Idarucizumab Pharmacokinetics



No differences in idarucizumab plasma concentrations when the drug was administered alone or after pretreatment with dabigatran.1


Rapidly binds to dabigatran; reverses anticoagulant effect of dabigatran within minutes.3 7 16



Limited extravascular distribution.1 Not known whether distributed into milk.1



Biodegraded into peptides and amino acids.1

Elimination Route

Excreted in urine (32.1% within 6 hours after administration and <1% during next 18 hours); remainder of dose presumed eliminated via renal catabolism.1 13 16


Initial half-life 47 minutes; terminal half-life 10.3 hours.1





2–8°C; do not freeze or shake.1

Unopened vials protected from light in original package may be kept at room temperature (25°C) for <48 hours.1

Unopened vials exposed to light may be kept at room temperature (25°C) for <6 hours.1


  • Recombinant IgG1 monoclonal antibody fragment; binds specifically to unbound and thrombin-bound dabigatran and acylglucuronide metabolites.1 8 14 16

  • High affinity of idarucizumab for dabigatran causes rapid formation of idarucizumab-dabigatran complex, leaving thrombin uninhibited and capable of triggering clotting.1 7 8 16 20

  • Reversal of dabigatran-mediated anticoagulation observed within minutes.3 7 16

  • Structurally similar to thrombin; lacks thrombin-like activity.8 9 16 20 Does not exhibit intrinsic procoagulant or anticoagulant effects.16

  • Does not affect activity of factor Xa inhibitors (apixaban, edoxaban, rivaroxaban), direct thrombin inhibitors (argatroban and hirudin), vitamin K antagonists (warfarin), or heparin.14

Advice to Patients

Importance of informing patients of signs and symptoms of allergic hypersensitivity reactions (e.g., anaphylaxis) that may occur during or after injection of idarucizumab.1

Importance of informing patients that reversing dabigatran therapy exposes them to thromboembolic risk of their underlying disease.1 Clinicians should consider resuming anticoagulant therapy as soon as the patient is sufficiently stable.1

Importance of advising patients to seek immediate medical attention for any signs or symptoms of bleeding.1

Importance of informing patients with hereditary fructose intolerance that idarucizumab solution for injection contains sorbitol.1 Importance of informing patients that parenteral sorbitol in patients with hereditary fructose intolerance associated with reports of hypoglycemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of hepatic excretory and synthetic function, and death; such effects may occur during or after injection of idarucizumab.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

Importance of informing patients of other important precautionary information. (See Cautions.)


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.



Dosage Forms


Brand Names



Injection, for IV use

50 mg/mL (2.5 g)


Boehringer Ingelheim

AHFS DI Essentials™. © Copyright 2021, Selected Revisions October 14, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.


1. Boehringer Ingelheim Pharmaceuticals, Inc. Praxbind (idarucizumab) injection prescribing information. Ridgefield, CT; 2015 Oct.

2. Food and Drug Administration. FDA Application: Search Orphan Drug Designations and Approvals. Silver Spring, MD. From FDA website. Accessed 2016 Jan 28.

3. Pollack CV, Reilly PA, Eikelboom J et al. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015; 373:511-20.

4. Glund S, Stangier J, Schmohl M et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015; 386:680-90.

5. Glund S, Moschetti V, Norris S et al. A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran. Thromb Haemost. 2015; 113:943-51.

6. Pollack CV, Reilly PA, Bernstein R et al. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015; 114:198-205.

7. Miyares MA, Kuyumjian Y, Eaves S et al. Idarucizumab, a humanized, monoclonal antibody fragment for immediate reversal of dabigatran. J Pharm Pract. 2015; 28:548-54.

8. Mo Y, Yam FK. Recent advances in the development of specific antidotes for target-specific oral anticoagulants. Pharmacotherapy. 2015; 35:198-207.

9. Das A, Liu D. Novel antidotes for target specific oral anticoagulants. Exp Hematol Oncol. 2015; 4:25.

10. Husted S, Verheugt FW, Comuth WJ. Reversal Strategies for NOACs: State of Development, Possible Clinical Applications and Future Perspectives. Drug Saf. 2016; 39:5-13.

11. Boehringer Ingelheim Pharmaceuticals, Inc. Pradaxa (dabigatran etexilate mesylate) capsules prescribing information. Ridgefield, CT; 2015 Nov.

12. Food and Drug Administration. Center for Drug Evaluation and Research: Application number 761025Orig1s000: medical review(s). From FDA website.

13. Food and Drug Administration. Center for Drug Evaluation and Research: Application number 761025Orig1s000: clinical pharmacology and biopharmaceutics review(s) . From FDA website.

14. Food and Drug Administration. Center for Drug Evaluation and Research: Application number 761025Orig1s000: summary review. From FDA website.

15. Food and Drug Administration. FDA news release: FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa. 2015 Oct 16. From FDA website.

16. Eikelboom JW, Quinlan DJ, van Ryn J et al. Idarucizumab: The Antidote for Reversal of Dabigatran. Circulation. 2015; 132:2412-22.

17. van Ryn J, Stangier J, Haertter S et al. Dabigatran etexilate--a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost. 2010; 103:1116-27.

18. Boehringer Ingelheim Pharmaceuticals. Management of medical emergency. Ridgefield, CT: 2015. Available at: Accessed 2016 Feb 5

19. Boehringer Ingelheim Pharmaceuticals,. Ridgefield, CT: Personal communication.

20. Schiele F, van Ryn J, Canada K et al. A specific antidote for dabigatran: functional and structural characterization. Blood. 2013; 121:3554-62.

21. Food and Drug Administration. Compliance Policy Guides: CPG sec. 400.335 fructose-containing drugs. From FDA website.

25. Tomaselli GF, Mahaffey KW, Cuker A et al. 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2017; 70:3042-3067.

26. Lip GYH, Banerjee A, Boriani G et al. Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report. Chest. 2018; 154:1121-1201.

27. January CT, Wann LS, Calkins H et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2019;