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idarucizumab

Generic Name: idarucizumab (EYE da roo KIZ ue mab)
Brand Name: Praxbind

What is idarucizumab?

Idarucizumab is a drug that reverses the effects of another medicine called dabigatran (Pradaxa). Dabigatran is used to prevent blood clots and strokes in people with certain heart disorders. Because the medicine keeps the blood from clotting, people taking dabigatran can bleed more easily.

Idarucizumab is used during a medical emergency to treat severe or uncontrolled bleeding that has been caused by taking dabigatran.

Idarucizumab is also used when an emergency surgery or other invasive medical procedure is needed in a person who takes dabigatran.

Idarucizumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about idarucizumab?

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

What should I discuss with my healthcare provider before receiving idarucizumab?

If possible before you receive idarucizumab, tell your doctor if you have hereditary fructose intolerance. Idarucizumab contains sorbitol (a sugar alcohol). Sorbitol can cause serious or life-threatening metabolic problems in people with hereditary fructose intolerance.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.

How is idarucizumab given?

Idarucizumab is injected into a vein through an IV. A healthcare provider will give you this injection.

After you receive idarucizumab, you may need follow-up blood tests to help your doctor determine how quickly your blood is clotting.

Once your condition is stable, you may need to restart dabigatran to prevent blood clots. Carefully follow your doctor's instructions about how soon to start taking your medicine(s) again.

What happens if I miss a dose?

Since idarucizumab is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

What happens if I overdose?

Since idarucizumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving idarucizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Idarucizumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

When the effects of dabigatran are reversed, you will not be protected against blood clots. Because of this, you may be susceptible to the effects of your underlying disease. Until you start taking dabigatran again, watch for signs and symptoms of blood clots, such as:

  • sudden numbness or weakness (especially on one side of the body);

  • problems with vision or speech;

  • chest pain, wheezing, coughing up blood; or

  • pain, swelling, warmth, or redness in one or both legs.

After you receive idarucizumab, tell your caregivers right away if you have:

  • any bleeding that will not stop;

  • lung problems--fever, chills, cough with yellow or green mucus, chest pain, feeling short of breath; or

  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • confusion, headache;

  • fever; or

  • constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Idarucizumab dosing information

Usual Adult Dose for Reversal of Dabigatran Anticoagulation:

5 g IV provided as two separate vials each containing 2.5 g/50 mL; administer as a bolus injection by injecting both vials consecutively one after another via syringe or as two consecutive infusions.

Comments:
-There is limited data to support administration of an additional 5 g.
-Resume anticoagulant therapy as soon as medically appropriate. Dabigatran can be initiated 24 hours after administration of this drug.

Use: Reversal of the anticoagulant effects of dabigatran in patients requiring emergency surgery/urgent procedures or in the event of life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval. Continued approval may be contingent upon the results of an ongoing cohort case series study.

What other drugs will affect idarucizumab?

Other drugs may interact with idarucizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about idarucizumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02.

Date modified: November 30, 2016
Last reviewed: January 21, 2016

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