Xyntha

Generic Name: antihemophilic factor (recombinant) (AN-tye-HEE-moe-FIL-ik FAK-tor)
Brand Name: Xyntha

Xyntha is used for:

Preventing and controlling bleeding in patients with hemophilia A (factor VIII deficiency), including in surgical settings. It may also be used for certain other bleeding conditions.

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 or to hamsters

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

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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
  • if you have been told that you have inhibitors to factor VIII

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 given as an injection at your doctor's office, hospital, or clinic. If you will be using Xyntha at home, a health care provider will teach you how to use it. Be sure you understand how to use Xyntha. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Wash your hands before and after use.
  • If Xyntha was stored in the refrigerator, let it reach room temperature before mixing. Do not heat it.
  • Mix by gently swirling. Do not shake.
  • Xyntha should be clear to slightly cloudy and colorless. Do not use Xyntha if it contains particles, is very cloudy or discolored, or if the vial is cracked or damaged.
  • Use Xyntha within 3 hours after it has been mixed, or after the gray rubber tip cap has been removed from the prefilled dual-chamber syringe. The medicine may be kept at room temperature during this time. Throw Xyntha away if it has not been used within 3 hours.
  • When drawing a dose into a syringe, be sure to follow the procedure demonstrated to you by your doctor to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers.
  • Carefully check that you have drawn the correct dose before administration.
  • 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. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Xyntha, call your doctor to find out what to do.

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

Important safety information:

  • 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.
  • Irritation at the injection site may occur after using the prefilled dual-chamber syringe. Check with your doctor if you have irritation that persists or is severe.
  • Lab tests 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; tiredness or weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

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; dizziness or light-headedness; fainting; fast heartbeat; fever; nausea or vomiting; shortness of breath; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

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

Proper storage of Xyntha:

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. Do not freeze. If stored at room temperature, make note of the date the product was placed at room temperature. Do not use past the expiration date.

Xyntha vials: If you have stored Xyntha at room temperature, it may be returned to the refrigerator until the expiration date. Do not do this more than 1 time. Discard any medicine remaining in the vial after you use it.

Xyntha Solofuse: Do not place Xyntha back in the refrigerator after storage at room temperature.

All products: 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Xyntha or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xyntha. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xyntha. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Xyntha.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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