Coagulation Factor Xa Recombinant, Inactivated-zhzo (koh-a-gyoo-LAY-shun FAK-tor TEN A re-KOM-bin-ant, in-AK-ti-vay-ted - zhzo)

Controls bleeding in patients receiving a blood thinner (including apixaban or rivaroxaban).

Brand Name(s):

Andexxa

When This Medicine Should Not Be Used:

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.
• This medicine may cause an increased risk for blood clots, including stroke and heart attack.
• Tell your doctor if this medicine does not prevent or stop bleeding as expected.
• 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
• Numbness or weakness in your arm or leg, or on one side of your body
• Sudden or severe headache, problems with vision, speech, or walking
• Unexplained bleeding

If you notice these less serious side effects, talk with your doctor:

• Bladder pain, bloody or cloudy urine, difficult, burning, or painful urination
• Cough, sneezing
• Pain, itching, burning, redness, swelling, or a lump under your skin where the needle is placed

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