Kogenate FS

Kogenate is a prescription medication used to prevent bleeding episodes in children and adults with hemophilia A (also known as "classical hemophilia"). Kogenate can also be used to reduce the risk of joint damage in children who do not have any current joint damage.

Kogenate belongs to a group of drugs called clotting factors. It works by replacing a protein in the blood that is needed to control bleeding that people with hemophilia A are missing.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Kogenate include infusion site reactions, rash, and itching.

Kogenate is a prescription medication used to prevent and control bleeding in adults and children with hemophilia A, a genetic disorder that increases bleeding and is caused by a missing or defective protein called factor VIII clotting factor. Kogenate may also be used to prevent bleeding during surgery, as well as reduce the risk of joint damage in children who do not have any current joint damage.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bayer Corp., Pharmaceutical/Biological Division

• Bayer Healthcare Pharmaceuticals Inc.

• Bayer Healthcare, LLC.

Serious side effects have been reported with Kogenate. See the "Kogenate Precautions" section.

Common side effects of Kogenate include the following:

• injection site reactions, including pain, swelling, and irritation at the injection site
• rash
• itching

This is not a complete list of Advate side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Kogenate including the following:

Hypersensitivity Reactions. Kogenate can cause serious allergic reactions. Tell your healthcare provider immediately about any signs or symptoms of an allergic reaction, which include the following:

• rash
• hives
• itching
• difficulty breathing or swallowing
• light-headedness
• dizziness
• nausea
• tightness of the chest or throat

Neutralizing antibodies. Your body may form inhibitors to factor VIII, known as antibodies. Antibodies are proteins made by the body as a natural part of the immune system in response to something it recognizes as foreign. If your form these inhibitors, Kogenate may not work properly. Your healthcare provider will monitor you for development of these inhibitors with blood tests.

Do not take Kogenate if you:

• are allergic to Advate or to any of its ingredients
• are allergic to mice or hamsters

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kogenate, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Kogenate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Kogenate or to any of its ingredients
• are allergic to mice or hamsters
• have heart problems or have been told you are at risk for heart problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Kogenate falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Kogenate should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Kogenate comes in an injectable form to be given directly into a vein (IV) by a healthcare professional. Kogenate is given as an infusion over a period of 15 minutes or less.

Your doctor may allow you to infuse Kogenate at home if you are regularly receiving this medication. Follow your doctor's instructions exactly on how to mix and administer Kogenate.

If you miss an appointment to receive a dose of Kogenate, contact your healthcare provider for instructions on when to receive your next dose.

The dose and duration of treatment of Kogenate your doctor recommends will be based on the following:

• your weight
• the severity of factor VIII deficiency
• your desired level of factor VIII determined by your doctor
• the location of the bleeding
• your overall clinical condition
• how you respond to this medication

The recommended dose of Kogenate when being used for control and prevention of bleeding episodes is 10 to 50 IU per kg of body weight, depending on the severity and location of the bleed. This dose is given every 8 to 24 hours as determined by your doctor until the bleeding is resolved.

The recommended dose of Kogenate when being given during surgery to prevent bleeding is 15 to 50 IU per kg of body weight given as a single dose before surgery. The dose may be repeated every 6 to 24 hours until bleeding is resolved or healing is complete as determined by your doctor.

The recommended dose of Kogenate when being used for routine prevention of bleeding in adults is 25 IU per kg body weight every 3 times per week. For children, the recommended dose is 25 IU/kg every other day.

Your doctor will perform blood tests to measure your level of factor VIII and may adjust your dose or frequency based on the results.

If you take too much Kogenate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Kogenate is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor and laboratory. Your doctor will order lab tests to check your levels of factor VIII to determine your dose and frequency of Kogenate.
• If you are infusing Kogenate at home, Store Kogenate at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kogenate FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F. Once store at room temperature, do not return the product to the refrigerator.
• Once mixed, use within 3 hours.
• Keep this and all medications out of the reach of children.