Kogenate FS recombinant

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

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

To make sure recombinant antihemophilic factor is safe for you, tell your doctor if you have heart disease.

It is not known whether recombinant antihemophilic factor 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.

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.

Recombinant antihemophilic factor 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 needles, IV tubing, and other items used.

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

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Recombinant antihemophilic factor must be mixed with a liquid (diluent) before injecting it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing the medicine 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 recombinant antihemophilic factor 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 recombinant antihemophilic factor, 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 medicine and the diluent in their original container in the refrigerator. 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 the medicine and diluent at room temperature until the expiration date on the label. Some brands of this medicine can be stored at room temperature for only a certain number of months, or until the expiration date (whichever comes first). Follow the storage directions on the medicine label.

If you store this medicine at room temperature, do not return it to the refrigerator.

Do not store this medicine in bright 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.

Since recombinant antihemophilic factor 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.

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

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

Stop using recombinant antihemophilic factor 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 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.

Applies to antihemophilic factor: intravenous powder for solution

Along with its needed effects, antihemophilic factor (the active ingredient contained in Kogenate FS) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking antihemophilic factor:

• Fever

• Changes in facial skin color
• chills
• fast or irregular breathing
• nausea
• puffiness or swelling of the eyelids or around the eyes
• sensation of burning, warmth, heat, numbness, tightness, or tingling
• skin rash, hives, or itching
• tightness in the chest
• troubled breathing
• unusual tiredness or weakness

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• chest pain or discomfort
• confusion
• cough
• deep or fast breathing with dizziness
• difficult or labored breathing
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• noisy breathing
• numbness of the feet, hands, and around the mouth
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow or irregular heartbeat
• sweating
• swelling of the face, throat, or tongue
• unusual tiredness or weakness

Some side effects of antihemophilic factor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache

• Burning, stinging, or swelling at the injection site
• diarrhea
• dizziness or lightheadedness
• dry mouth or bad taste in the mouth
• lack or loss of strength
• nosebleed
• redness of the face
• vomiting

• Change in taste
• loss of taste

• Abdominal or stomach pain
• feeling of warmth
• increased sweating
• irritability
• muscle or bone pain
• redness of the eye
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• trouble seeing