Praxbind 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.

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

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

Praxbind 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 Praxbind.

Praxbind is given as an infusion into a vein. A healthcare provider will give you this injection.

After you receive Praxbind, 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.

If possible before you receive Praxbind, tell your doctor if you have hereditary fructose intolerance. This medicine 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 Praxbind in a clinical setting, you are not likely to miss a dose.

Since Praxbind 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 Praxbind, tell your caregivers right away if you have any bleeding that will not stop.

Common side effects of Praxbind 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 Praxbind, 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.