Xyntha

Xyntha is used for:

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Preventing and controlling bleeding in patients with hemophilia A (factor VIII deficiency), including in surgical settings.

Xyntha is a clotting factor. It works by increasing the amount of clotting factor VIII in the blood, which helps the blood to clot normally.

Do NOT use Xyntha if:

• you are allergic to any ingredient in Xyntha

Contact your doctor or health care provider right away if this applies to you.

Before using Xyntha :

Some medical conditions may interact with Xyntha . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances, including polysorbate 80 and hamster proteins

Some MEDICINES MAY INTERACT with Xyntha . However, no specific interactions with Xyntha are known at this time.

Ask your health care provider if Xyntha may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xyntha :

Use Xyntha as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xyntha . Talk to your pharmacist if you have questions about this information.
• Xyntha is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Xyntha at home, carefully follow the injection procedures taught to you by your health care provider.
• Do not use Xyntha if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Use Xyntha within 3 hours after it has been mixed.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Xyntha , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Xyntha .

Important safety information:

• Tell your doctor right away if bleeding is not controlled after using Xyntha .
• Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes it less effective. If Xyntha stops working or does not work as well as it has before, contact your doctor right away for instructions.
• Talk with your doctor before you travel while you are using Xyntha . Be sure to take along enough of Xyntha for your treatment while you are traveling.
• Tell your doctor or dentist that you take Xyntha before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including factor VIII levels, may be performed while you use Xyntha . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xyntha while you are pregnant. It is not known if Xyntha is found in breast milk. If you are or will be breast-feeding while you use Xyntha , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xyntha :

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild fever; nausea; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue lips, gums, or nail beds; fainting; fast heartbeat; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Store Xyntha in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). It may also be stored at room temperature, below 77 degrees F (25 degrees C), for up to 3 months. Store the diluent syringe in the refrigerator or at room temperature, below 77 degrees F (25 degrees C). After mixing, you may store Xyntha at room temperature for up to 3 hours. Store Xyntha away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Xyntha out of the reach of children and away from pets.

General information:

• If you have any questions about Xyntha , please talk with your doctor, pharmacist, or other health care provider.
• Xyntha is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xyntha . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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