KOĀTE is a human plasma derived anti-hemophilic factor indicated 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 indicated for the treatment of von Willebrand disease.
IMPORTANT SAFETY INFORMATION
KOĀTE is contraindicated in patients who have had hypersensitivity reactions including anaphylaxis, to KOĀTE or its components. If hypersensitivity symptoms occur, discontinue use of the product immediately and administer appropriate emergency treatment.
The formation of neutralizing antibodies (inhibitors) to FVIII may occur. If expected plasma FVIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration.
Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B or AB blood groups who are receiving large or frequent doses.
KOĀTE is made from human plasma 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.
The most common adverse drug reactions (frequency > 5% of subjects) observed in the clinical trial were nervousness, headache, abdominal pain, nausea, paresthesia and blurred vision. To report SUSPECTED ADVERSE REACTIONS contact Kedrion Biopharma at 1-855-353-7466.
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.
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