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Idarucizumab

Generic name: idarucizumab [EYE-da-roo-KIZ-ue-mab]
Brand Name:Praxbind
Form of dosage:
intravenous (2.5 g/50 ml) solution
Drug Class: Reversal agents for anticoagulants

What is Idarucizumab?

Idarucizumab reverses the effects of a medicine called Dabigatran (Pradaxa). Dabigatran prevents blood clots, strokes, and heart attacks in patients with certain heart conditions. Dabigatran prevents the blood from clotting, so people can bleed easier.Idarucizumab can be used in an emergency situation to control bleeding caused by dabigatran.

Idarucizumab can also be used to treat dabigatran users who need an urgent surgical procedure or another invasive medical procedure.Idarucizumab can be used in other ways not mentioned in this guide.

Side effects of Idarucizumab

If you experience any of the following: hives; itching; difficulty breathing; swelling in your face, lips, or throat;

You will no longer be protected from blood clots when dabigatran's effects are reversed. You may then be more susceptible to the effects of your underlying condition. Watch for symptoms and signs of blood clots until you begin taking dabigatran.

  • A sudden feeling of numbness or weakness on a side
  • Problems with speech or vision
  • Chest pain, wheezing, or coughing blood
  • Pain, swelling, warmth, or redness on one or both legs

Tell your carers immediately if any bleeding does not stop after you have received idarucizumab.

Idarucizumab can cause a number of side effects.

  • Confusion, headache;
  • Constipation.

There may be other side effects. Call your doctor for medical advice about side effects. To report adverse effects, you can contact the FDA at 1-800-FDA-1088.

Similar/related drugs

Praxbind

Warnings

You may not be able to tell your carers what you are going through in an emergency. Ensure that any doctor who treats you in the future knows you have received idarucizumab.

Before you take this drug

Before receiving idarucizumab, tell your doctor about hereditary fructose tolerance. Idarucizumab is a sugar alcohol containing sorbitol. Sorbitol may cause serious or even life-threatening metabolic issues in people who have hereditary intolerance to fructose.

You may not know if you're pregnant or breastfeeding in an emergency. Be sure to tell any doctor who is caring for you or your baby that you have taken this medication.

How to take Idarucizumab?

Idarucizumab can be infused into a vein. This injection will be given by a healthcare provider.You may need to have blood tests done after receiving idarucizumab. This will help your doctor determine the speed at which your blood clots.

You may need to restart dabigatran once your condition has stabilized to prevent blood clots. Follow your doctor's instructions on when to take your medication again.

Details on dosage

Adult dose for reversal of anticoagulation:

Five grammes of IV are provided in two vials, each with 2.5 50 ml. Administer as a bolus by injecting the two vials one after another using syringes or two consecutive infusions.
Comments:
There is limited data that supports the administration of 5 g.
Resume the anticoagulant treatment as soon as it is medically necessary. Dabigatran may be started 24 hours after the drug has been administered.
Use: Reversal the anticoagulant effect of dabigatran for patients who require emergency surgery or urgent procedures, or when there is uncontrolled or life-threatening bleeding. This indication has been approved under the accelerated approval process. The results of a cohort case series may determine whether or not the approval is continued.

What happens if I miss the dose?

You are unlikely to miss a dose of idarucizumab because you will be receiving it in a clinical environment.

What happens if I overdose?

Overdoses are unlikely because idarucizumab will be administered by a healthcare provider in a medical environment.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

Idarucizumab can be affected by other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medications you take, including those you start or stop using.