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Xyntha

Generic Name: antihemophilic factor (recombinant) (ant ee hee moe FIL ik FAK tor (ree KOM bin ant))
Brand Names: Advate rAHF-PFM, Helixate FS, Kogenate FS, Kogenate FS with Bioset, Recombinate, Refacto, Xyntha

What is Xyntha?

Xyntha contains antihemophilic factor, a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

Xyntha works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Xyntha is used to treat or prevent bleeding episodes in adults and children with hemophilia A (congenital factor VIII deficiency or classic hemophilia).

It is also used to control bleeding related to surgery or dentistry in a person with hemophilia A.

Xyntha is not for use in people with von Willebrand disease.

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

Important information

Do not use Xyntha if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse or beef proteins.

Before using Xyntha, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human antihemophilic factor will not treat von Willebrand disease.

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Your body may develop antibodies to Xyntha, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure Xyntha is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Before using Xyntha

Do not use Xyntha if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse or beef proteins.

Before using Xyntha, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Xyntha will not treat von Willebrand disease.

FDA pregnancy category C. It is not known whether Xyntha will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether recombinant antihemophilic factor passes into breast milk or if it could harm a nursing baby. Do not use Xyntha without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I use Xyntha?

Use Xyntha exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Xyntha is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Xyntha comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Xyntha must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to reach room temperature before mixing them.

Gently swirl the medicine and diluent to mix them and allow the medicine to completely dissolve.

After mixing the Xyntha and diluent, the mixture should be kept at room temperature and must be used within 3 hours. If you have not used it in 3 hours, throw it away. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use Xyntha if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Xyntha is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medication.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Store Xyntha and the diluent in the refrigerator and do not allow them to freeze. Xyntha can last at room temperature for up to 3 months. After room temperature storage, Xyntha can be returned to the refrigerator until the expiration date. Do not store Xyntha at room temperature and return it to the refrigerator more than once. If you store Xyntha at room temperature, be careful to write down the date you put Xyntha at room temperature, so you will know when to either put it back in the refrigerator, use it immediately, or throw it away. There is a space on the carton for you to write the date.

Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Xyntha is sometimes used only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed 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?

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

Xyntha side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Xyntha: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using Xyntha and call your doctor at once if you have a serious side effect such as:

  • chest pain;

  • easy bruising, increased bleeding episodes; or

  • bleeding from a wound or where the medicine was injected.

Less serious Xyntha side effects may include:

  • sore throat, cough, runny nose;

  • fever or chills;

  • mild nausea, vomiting;

  • unusual or unpleasant taste in your mouth;

  • skin itching or rash;

  • warmth, redness, itching, or tingling under your skin;

  • joint pain or swelling;

  • dizziness;

  • headache; or

  • swelling, stinging, or irritation where the injection was given.

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.

See also: Side effects (in more detail)

What other drugs will affect Xyntha?

There may be other drugs that can interact with Xyntha. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Xyntha.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xyntha only for the indication prescribed.
  • Disclaimer: 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 1996-2014 Cerner Multum, Inc. Version: 6.02. Revision Date: 2012-1-5, 10:20:27 AM.

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