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.

In an emergency, you may not be able to tell caregivers about your health conditions. Make sure any doctor caring for you afterward knows you received idarucizumab.

Idarucizumab is given as an infusion into a vein. 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.

Usual Adult Dose for Reversal of 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.

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, you may not be able to tell caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

Because you will receive idarucizumab in a clinical setting, you are not likely to miss a dose.

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

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

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.

Common side effects of idarucizumab 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.

Other drugs may affect idarucizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.