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|Kogenate FS

Kogenate FS

Kogenate FS 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.

Kogenate FS is man-made clotting factor. It is identical to the naturally occurring protein in the body. It works by increasing the amount of clotting factor VIII in the blood, which helps the blood to clot normally.

Do NOT use Kogenate FS if:

• you are allergic to any ingredient in Kogenate FS , including mouse, hamster, or bovine proteins

Contact your doctor or health care provider right away if any of these apply to you.

Before using Kogenate FS :

Some medical conditions may interact with this medicine. 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

Some MEDICINES MAY INTERACT with Kogenate FS . However, no specific interactions with Kogenate FS are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kogenate FS 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 Kogenate FS :

Use Kogenate FS as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not shake Kogenate FS .
• Kogenate FS is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Kogenate FS at home, carefully follow the injection procedures taught to you by your health care provider.
• If Kogenate FS contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• This product must be used within 3 hours after it has been prepared.
• 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. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Kogenate FS , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If more than one dose is missed, restart therapy as needed and contact your doctor at your next appointment.

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

Important safety information:

• Kogenate FS may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Kogenate FS . Using Kogenate FS alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes it less effective. If Kogenate FS stops working or does not work as well as it has before, contact your doctor immediately for instructions.
• Lab tests, including factor VIII levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Kogenate FS during pregnancy. If you are or will be breast-feeding while you are using Kogenate FS , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Kogenate FS :

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:

Chest discomfort; dizziness; fever; flushing; injection site reactions (burning, itching, redness); nausea; rash; sore throat; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Kogenate FS in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, up to 77 degrees F (25 degrees C), for 2 months. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Kogenate FS out of the reach of children and away from pets.

General information:

• If you have any questions about Kogenate FS , please talk with your doctor, pharmacist, or other health care provider.
• Kogenate FS 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.

This information is a summary only. It does not contain all information about Kogenate FS . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.