Approved Use

KOĀTE (Antihemophilic Factor (Human)) is a medicine used for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). KOĀTE is not approved for the treatment of von Willebrand disease.

Important Safety Information

• Do not use KOĀTE if you have had an allergic reaction to KOĀTE or any of its components.
• Tell your healthcare provider about all of your medical conditions, including any medicines you take, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
• Allergic reactions, including serious, life-threatening allergic reactions, are possible from the administration of antihemophilic factor preparations such as KOĀTE. Immediately report any of the following signs or symptoms of an allergic reaction to your healthcare provider: swelling of the throat, tightness of the chest, low blood pressure, rash, nausea, vomiting, a tingling or pricking sensation, restlessness, wheezing or shortness of breath.
• Antibodies neutralizing Factor VIII (also known as inhibitors), which can make the product less effective or ineffective, may form with use of KOĀTE. Your healthcare provider will monitor you for the development of inhibitors.
• There is a risk of increased breakdown of red blood cells (or hemolytic anemia) in patients with blood groups A, B or AB when large or frequent doses of KOĀTE are given. Your healthcare provider will monitor your levels of red blood cells and look out for signs of red blood cell breakdown.
• KOĀTE is made from human blood and, therefore, carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.
• In a clinical study, the most common side effects associated with the infusion of KOĀTE were nervousness, headache, abdominal pain (stomach ache), nausea, tingling sensation and blurred vision.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional safety information, please see Full Prescribing Information.

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