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Brand Names: Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P

Generic Name: antihemophilic factor (human) (Pronunciation: an tee hee moe FIL ik FAK tor)

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

What is human antihemophilic factor (Koate)?

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.

Human 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.

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

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

What are the possible side effects of human antihemophilic factor (Koate)?

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:

• easy bruising, increased bleeding episodes;
• bleeding from a wound or where the medicine was injected;
• fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea or stomach pain.
• tingly or jittery feeling;
• blurred vision;
• headache; or
• swelling, stinging, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about human antihemophilic factor (Koate)?

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 proteins.

Before using human 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 appointments.

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.

Human antihemophilic factor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.