Antihemophilic Factor (Recombinant) Plasma/Albumin-Free (an-tee-hee-moe-FIL-ik FAK-tor (re-KOM-bin-ant) PLAZ-ma/al-BYOO-min-free)
Prevents and controls bleeding episodes in people who have hemophilia A (classic hemophilia), including bleeding during surgery. This medicine is blood clotting Factor VIII.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not receive this medicine if you have had an allergic reaction to antihemophilic factor (recombinant), plasma/albumin-free method (also called rAHF-PFM), or to mouse or hamster proteins (found in drugs such as abciximab, darbepoetin alfa, infliximab, Aranesp?, Remicade®, Rituxan®, or Reopro®) unless your doctor feels that it is appropriate. Talk to your doctor if you have concerns.
How to Use This Medicine
- Your doctor will prescribe your exact dose and tell you how often it should be given. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to. This medicine is given through a needle placed in one of your veins.
- A nurse or other trained health professional will give you this medicine.
- You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
- Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
- Use a new needle and syringe each time you inject your medicine. You must use a plastic syringe. One is provided in the package with your medicine.
Xyntha® injection is available as a powder that is mixed with a special liquid (0.9% sodium chloride solution) in one prefilled dual-chamber syringe. It must be used within 3 hours after it is mixed or after removal of the grey rubber tip cap from the prefilled dual-chamber syringe. You may store the mixed liquid at room temperature before injecting the medicine. Throw away any unused medicine after 3 hours.
- Do not use Xyntha® or Advate® injection if the mixed liquid is not clear.
Advate® injection is a powder that must be mixed with a special liquid (sterile water) before you use it. The sterile water should come in the same package with the medicine. Let both the powdered medicine and the sterile water warm up to room temperature before you mix them together. After you mix the powdered medicine with the water, store at room temperature and use within 3 hours.
- This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
- Talk to your doctor before traveling. You should plan to bring enough medicine for your treatment when traveling.
If a dose is missed:
- Call your doctor or pharmacist for instructions.
How to Store and Dispose of This Medicine
- If you store this medicine at home, keep it in the refrigerator. Do not freeze.
- If needed, you may also store the medicine at room temperature for short periods of time. Store this medicine as directed by your doctor or by the manufacturer, depending on which brand you are using. Write the date you removed the medicine from the refrigerator on the carton. If you have already stored this medicine at room temperature, do not return it to the refrigerator. Protect the carton from heat and direct light.
- After you mix the powder with the sterile water, do not store the mixture in the refrigerator. Keep the mixture at room temperature and use it within 3 hours.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
- Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
- Keep all medicine away from children and never share your medicine with anyone.
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
- Make sure your doctor knows if you are pregnant or breastfeeding.
- This medicine treats only hemophilia A (classic hemophilia). People who have hemophilia A are missing an important protein in their blood that makes the blood clot. This protein is called Factor VIII. This medicine does not treat any other kind of hemophilia or blood clotting problem.
- This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; lightheadedness or dizziness; or any swelling of your hands, face, or mouth after you have receive this medicine.
- Your body may have substances called "inhibitors" that may react against Xyntha® and may cause the medicine to stop working properly. Check with your doctor right away if you notice that your medicine seems not to be working properly or less effective than usual.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
- If your symptoms do not improve or if they get worse, call your doctor.
- It is recommended that you carry identification stating that you have hemophilia A, and what medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.
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.
- Lightheadedness, dizziness, or fainting.
- Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
- Unusual bleeding, bruising, or weakness.
If you notice these less serious side effects, talk with your doctor:
- Nausea, upset stomach, diarrhea, or constipation.
- Runny or stuffy nose.
- Skin rash or itchiness.
- Unusual taste in your mouth or a change in how things taste.
- Warmth or redness in your face, neck, arms, or upper chest.
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
Review Date: 2011-02-04