Xyntha

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. It is used to treat or prevent bleeding episodes in adults and children with hemophilia A. Xyntha is also used to control bleeding related to surgery or dentistry in a person with hemophilia.

Xyntha may also be used for other purposes not listed here.

Important information about 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. Recombinant antihemophilic factor will not treat von Willebrand disease.

Your body may develop antibodies to Xyntha, making it less effective. Call your doctor if Xyntha 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 on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. 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. Recombinant antihemophilic factor will not treat von Willebrand disease.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. 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.

How should I use Xyntha?

Use Xyntha exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions 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 given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use Xyntha at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving 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 medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Draw your dose into 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 any 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 Xyntha is helping your condition and is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

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

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Xyntha should be stored under refrigeration at a temperature of 2? to 8?C (36?to 46?F). Xyntha may also be stored at room temperature not to exceed 25?C (77?F) for up to 3 months, until the expiration date. You should write in the space provided on the outer carton, the date the product was placed at room temperature. At the end of the 3-month period, the product should not be put back into the refrigerator, but should be used immediately or discarded. The diluent syringe may be stored at 2? to 25?C (36? to 77?F). Freezing should be avoided to prevent damage to the pre-filled diluent syringe. During storage, avoid prolonged exposure of Xyntha vial to light. Do not use Xyntha after the expiration date on the label. Follow the storage directions on the medicine label.

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 using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Call your doctor if you think you have used too much of this medicine. An overdose of Xyntha is not expected to produce life-threatening symptoms.

What should I avoid while using Xyntha?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Xyntha.

Xyntha side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 any of these serious side effects:

chest pain;

easy bruising, increased bleeding episodes; or

bleeding from a wound or where the medicine was injected.

Less serious 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Xyntha side effects (in more detail)

What other drugs will affect Xyntha?

There may be other drugs that can affect Xyntha. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Xyntha.