Kogenate FS contains recombinant antihemophilic factor. Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

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

Kogenate FS is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage.

Kogenate FS is not for use in people with von Willebrand disease.

You should not use Kogenate FS if you have ever had a severe allergic reaction to antihemophilic factor in the past.

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.

Carefully follow all instructions about how to store this medicine. Each brand of recombinant antihemophilic factor may have specific instructions about keeping the medicine in a refrigerator or at room temperature, and for only a certain number of months.

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

To be sure Kogenate FS 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.

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

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

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

This medicine 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.

Kogenate FS must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take the medicine and diluent out of the refrigerator and warm both vial and syringe in your hands to a comfortable temperature (do not exceed 37°C or 99°F).

Gently swirl the Kogenate FS and diluent to mix them and allow the medicine to completely dissolve. Do not shake the vial.

After mixing the Kogenate FS and diluent, keep the mixture at room temperature and use it within 3 hours. Do not put mixed medicine into a refrigerator.

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

Do not use Kogenate FS if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using Kogenate FS, you may need frequent blood tests.

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.

Carefully follow all instructions about how to store this medicine. Each brand of recombinant antihemophilic factor may have specific storage instructions.

Store the Kogenate FS and the diluent in the refrigerator for up to 30 months from the date of manufacture. Do not freeze.

Before preparing your dose, take the medicine and diluent out of the refrigerator and allow them to reach room temperature.

You may also store Kogenate FS and diluent at room temperature for a period of up to 12 months.

Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Store Kogenate FS vials in their original carton and protect them from extreme exposure to light. Throw away any leftover medicine and diluent if the expiration date has passed.

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.

You should not use Kogenate FS if you have ever had a severe allergic reaction to antihemophilic factor, or if you are allergic to mouse or beef proteins.

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

To make sure Kogenate FS is safe for you, tell your doctor if you have heart disease.

It is not known whether Kogenate FS will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether recombinant antihemophilic factor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby while using Kogenate FS.

Since Kogenate FS is used when needed, you may not be on a dosing schedule. If you are on a schedule, 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Stop using Kogenate FS and call your doctor at once if you have:

• chest pain;

• easy bruising, increased bleeding episodes; or

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

Common Kogenate FS side effects may include:

• nausea, vomiting, diarrhea;

• headache, dizziness;

• joint pain;

• rash;

• sore throat, cough, stuffy nose;

• weakness, feeling tired;

• fever; or

• pain, swelling, itching, 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.

Other drugs may interact with recombinant antihemophilic factor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.