idarucizumab (Praxbind)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

Deep Vein Thrombosis (DVT)

What is idarucizumab, and how does it work (mechanism of action)?

Dabigatran prevents blood clots by binding to thrombin and preventing thrombin from combining with other proteins to form a blood clot. Dabigatran increases the risk of bleeding because it reduces the ability of blood to clot. Patients who are taking dabigatran may develop serious or life threatening bleeding or may require surgery urgently. In such situations the effect of dabigatran needs to be reversed so that blood can clot normally. Idarucizumab reverses the effect of dabigatran by binding to Pradaxa and preventing it from binding to thrombin, allowing blood to clot normally. The FDA approved idarucizumab on October 2015.

What brand names are available for idarucizumab?

Praxbind

Is idarucizumab available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for idarucizumab?

Yes

What are the uses for idarucizumab?

Idarucizumab (Praxbind) is an antibody used for reversing the effect of Pradaxa (dabigatran) for emergency surgery/urgent procedures or if life-threatening or uncontrolled bleeding occurs while taking dabigatran. Dabigatran is an anticoagulant (blood thinner) that is used for preventing blood clots in people with non-valvular atrial fibrillation and for treating deep venous thrombosis (DVT) and pulmonary embolism (PE).

What are the side effects of idarucizumab?

Common side effects of idarucizumab include:

Other reported side effects include:

  • Allergic reactions
  • Increased levels of laboratory markers for blood clotting
  • Idarucizumab antibodies

Possible serious side effects of idarucimab include:

  • Reversing the effect of dabigatran removes the protective effect of dabigatran in people who are at risk for blood clots. Therefore, anticoagulation should be started as soon as possible after treatment with idarucizumab.
  • If patients continue to bleed or require a second emergency surgery/urgent procedure, an additional 5 g dose of idarucizumab may be considered.
  • Idarucizumab contains sorbitol. Patients with hereditary fructose intolerance may be at risk for adverse reactions. 

Quick GuideDVT in Pictures: Symptoms of Deep Vein Thrombosis, Beyond Leg Pain and More

DVT in Pictures: Symptoms of Deep Vein Thrombosis, Beyond Leg Pain and More

What is the dosage for idarucizumab?

  • The recommended dose of idarucizumab is 5 g (2 vials) given as two 2.5 mg intravenous infusions or two injections.
  • An additional 5 g may be considered for patients who continue to bleed.

Which drugs or supplements interact with idarucizumab?

Is idarucizumab safe to take if I'm pregnant or breastfeeding?

  • There are no adequate or well-controlled trials of idarucizumab use in pregnant women. Therefore, idarucizumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • It is not known if idarucizumab is excreted into human milk.

What else should I know about idarucizumab?

What preparations of idarucizumab are available?

  • Solution for injection: Two single use vials each containing 2.5 g/50 ml.

How should I keep idarucizumab stored?

  • Store idarucizumab vials in the refrigerator at 2 C to 8 C (36 F to 46 F).
  • Do not freeze.
  • Do not shake.

REFERENCE: FDA Prescribing Information.

Quick GuideDVT in Pictures: Symptoms of Deep Vein Thrombosis, Beyond Leg Pain and More

DVT in Pictures: Symptoms of Deep Vein Thrombosis, Beyond Leg Pain and More

Summary

Idarucizumab (Praxbind) is a prescription drug used to prevent blood clots in people with non-valvular atrial fibrillation and for treating DVT (deep vein thrombosis), and pulmonary embolism. Side effects, drug interactions, dosing, storage, and pregnancy and breastfeeding information should be reviewed prior to taking this medication.

Treatment & Diagnosis

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Reviewed on 1/5/2016
References
REFERENCE: FDA Prescribing Information.

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