Andexxa is a protein that reverses the effects of certain anticoagulant medications that are used to treat or prevent blood clots. Reversing anticoagulant medicine is necessary if you have uncontrolled or life-threatening bleeding as a result of how that medicine works.

Andexxa is used to treat uncontrolled bleeding in people who take the anticoagulants rivaroxaban (Xarelto) and apixaban (Eliquis).

Andexxa was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, healthy volunteers responded to Andexxa, but further studies are needed.

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

Andexxa is used to reverse the effects of anticoagulant medication, which may increase your risk of a blood clot, heart attack, stroke, or death. Watch for symptoms such as chest pain, sudden numbness or weakness, problems with vision or speech, and swelling or redness in an arm or leg.

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

Andexxa must be given slowly, and the infusion can take at least 2 hours to complete.

Once your bleeding has been controlled, you may need to begin using anticoagulant medication again to prevent future blood clots. Follow your doctor's instructions very carefully.

You should not be treated with Andexxa if you have had an allergic reaction to clotting factor medicine.

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 this medicine.

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 Andexxa in a clinical setting, you are not likely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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; difficult breathing; swelling of your face, lips, tongue, or throat.

Andexxa may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate;

• cough with mucus, chest pain, and shortness of breath;

• fever, chills; or

• continued bleeding after treatment.

Reversing the effects of anticoagulant medication may increase your risk of a blood clot, heart attack, stroke, or death. Get emergency medical help if you have any of these symptoms after being treated with Andexxa, especially if you have not started taking anticoagulant medication again:

• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg; or

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects of coagulation factor Xa may include:

• lung problems;

• painful urination; or

• pain, swelling, burning, or irritation around the IV needle.

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 Andexxa, 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.