Kogenate FS (recombinant)

Antihemophilic factor (clotting factor) is a protein that normally occurs in the blood. People with hemophilia A do not have enough clotting factor VIII. Recombinant antihemophilic factor is used to replace clotting factor VIII in the blood.

Recombinant antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. This medicine may also be given before a surgery.

Recombinant antihemophilic factor can help prevent joint damage in children with hemophilia A who have not had any joint damage before.

Recombinant antihemophilic factor is not for treating von Willebrand disease.

Jivi is not approved for anyone younger than 12 years old.

Recombinant antihemophilic factor may also be used for other purposes not mentioned in this medication guide.

Carefully follow all instructions on how to mix and store this medicine. Different brands of recombinant antihemophilic factor may have different storage instructions.

Your body may develop antibodies to antihemophilic factor, which can make it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

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 or hamster proteins. You should not use the brand Recombinate if you are allergic to beef proteins.

Tell your doctor if you have ever had:

• heart disease;
• a latex allergy; or
• if you have ever been told that you have inhibitors to Factor VIII.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you notice signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficulty breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Kogenate FS may lead to serious side effects. Contact your doctor immediately if you experience:

• increased bleeding episodes;
• any bleeding that does not stop;
• chest pain; or
• a light-headed feeling, as if you might faint.

Common side effects of Kogenate FS may include:

• nose bleeds;
• nausea, vomiting, diarrhea;
• headache, dizziness;
• muscle or joint pain;
• rash;
• flushing (sudden warmth, redness, or tingling);
• fever, chills;
• cough;
• weakness; or
• pain, swelling, itching, or redness at the injection site.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Your doctor will perform a blood test to make sure recombinant antihemophilic factor is the right treatment for your clotting factor deficiency.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor may occasionally change your dose. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Recombinant antihemophilic factor is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Recombinant antihemophilic factor must be mixed with a liquid (diluent) before using it. Ask your doctor or pharmacist if you don't understand how to properly mix and store the medicine.

Always wash your hands before preparing and giving your injection.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Recombinant antihemophilic factor doses are based on weight. Your dose needs may change if you gain or lose weight.

You will need frequent medical 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.

Get your prescription refilled before you run out of medicine completely. While traveling away from home, be sure you have enough medicine and injection supplies with you.

Store unmixed recombinant antihemophilic factor in the original package in a refrigerator. Do not freeze. Take the medicine out of the refrigerator and let it reach room temperature before preparing your dose.

You may also store unmixed recombinant antihemophilic factor at room temperature, but you must not return it to the refrigerator. 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).

Carefully follow all instructions about how to store this medicine. Different brands of recombinant antihemophilic factor may have different storage instructions.

Do not store in bright light. Do not use past the expiration date on the label.

After mixing the medicine and diluent, keep the mixture at room temperature (not in a refrigerator) and use it within 3 hours.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have a bleeding or blood-clotting disorder.

Since antihemophilic factor (recombinant) is used as needed, you might not have a regular dosing schedule. However, you may need to take the medicine for several days in a row to manage a bleeding episode. Keep using the medicine as instructed and inform your doctor if your bleeding does not stop.

Take any missed dose as soon as you remember. Do not take two doses at the same time.

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

Follow your doctor's advice regarding any limits on food, drinks, or activities.

Other drugs may affect antihemophilic factor (recombinant), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any medicine you begin or stop using.