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Koate
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  • FDA PI

Koate

Generic name:antihemophilic factor (human)
Dosage form: injection
Drug class:Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Apr 1, 2022.

Indications and Usage

KOĀTE® is a human plasma-derived antihemophilic 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).

Limitation of Use

KOĀTE is not indicated for the treatment of von Willebrand disease.

Dosage and Administration

For intravenous use after reconstitution only.

Dose

  • Dose and duration of treatment depend on the severity of the Factor VIII deficiency, location and extent of bleeding, and the patient’s clinical condition.
  • Each vial of KOĀTE is labeled with the actual Factor VIII potency in international units (IU). Calculation of the required dose of Factor VIII is based on the empirical finding that one IU of Factor VIII per kg body weight raises the plasma Factor VIII activity by approximately 2% of normal activity or 2 IU/dL.
  • The required dose can be determined using the following formula:

    Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (% normal or IU/dL) x 0.5

  • Estimate the expected in vivo peak increase in Factor VIII level, expressed as IU/dL (or % normal), using the following formula:

    Estimated Increment of Factor VIII
    (% normal or IU/dL) = [Total Dose (IU)/Body Weight (kg)] x 2

  • Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency on the individual clinical response.

Control and Prevention of Bleeding Episodes

A guide for dosing KOĀTE for the control and prevention of bleeding episodes (1,2) is provided in

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