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Idarucizumab (Injection) (Injectable)

(PRAXBIND)
Idarucizumab (By injection)
Idarucizumab (eye-da-roo-SIZ-ue-mab)Used during emergency or life-threatening situations when bleeding cannot be controlled and the patient is using dabigatran (a blood thinner).
Praxbind

When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to idarucizumab.

How to Use This Medicine:
Injectable

  • Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
  • A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.


Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have bleeding problems or a history of blood clot problems. Tell your doctor if you have hereditary fructose intolerance, because this medicine contains sorbitol.
  • This medicine may cause the following problems:
    • Increased risk of blood clots
    • Bleeding problems
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain, trouble breathing, coughing up blood
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088