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Brand Names: Advate rAHF-PFM, Helixate FS, Kogenate FS, Kogenate FS with Bioset, Recombinate, Refacto

Generic Name: antihemophilic factor (recombinant) (Pronunciation: ant ee hee moe FIL ik FAK tor (ree KOM bin ant))

• What is recombinant antihemophilic factor (Helixate FS)?
• What are the possible side effects of recombinant antihemophilic factor?
• What is the most important information I should know about recombinant antihemophilic factor?
• What should I discuss with my health care provider before using recombinant antihemophilic factor?
• How should I use recombinant antihemophilic factor?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while using recombinant antihemophilic factor?
• What other drugs will affect recombinant antihemophilic factor?
• Where can I get more information?

What is recombinant antihemophilic factor (Helixate FS)?

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.

This medication works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Recombinant antihemophilic factor 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.

Recombinant antihemophilic factor is not for use in people with von Willebrand disease.

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

What are the possible side effects of recombinant antihemophilic factor?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• chest pain;
• easy bruising, increased bleeding episodes; or
• bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

• sore throat, cough, runny nose;
• fever or chills;
• mild nausea, vomiting;
• unusual or unpleasant taste in your mouth;
• skin itching or rash;
• warmth, redness, itching, or tingling under your skin;
• joint pain or swelling;
• dizziness;
• headache; or
• swelling, stinging, 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.

What is the most important information I should know about recombinant antihemophilic factor?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse or beef proteins.

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

Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.