Alert

coagulation factor Xa

Pronunciation: koe AG ue LAY tion FAK tor Xa

Brand: Andexxa

What is the most important information I should know about coagulation factor Xa?

This medicine 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.

What is coagulation factor Xa?

Coagulation factor Xa 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.

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

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

Coagulation factor Xa may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving coagulation factor Xa?

You should not be treated with coagulation factor Xa 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.

How is coagulation factor Xa given?

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

This medicine 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.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid after receiving coagulation factor Xa?

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

What are the possible side effects of coagulation factor Xa?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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 coagulation factor Xa, 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.

What other drugs will affect coagulation factor Xa?

Other drugs may affect coagulation factor Xa, 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.

Where can I get more information?

Your pharmacist can provide more information about coagulation factor Xa.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2019 Cerner Multum, Inc. Version: 1.02. Revision date: 4/17/2019.

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