Kovaltry

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

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Indications and Usage for Kovaltry

Kovaltry, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:

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On-demand treatment and control of bleeding episodes

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Perioperative management of bleeding

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Routine prophylaxis to reduce the frequency of bleeding episodes

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

Kovaltry Dosage and Administration

For intravenous use after reconstitution only.

Dose

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Dosage and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.

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Each vial label of Kovaltry states the Factor VIII potency in international units (IU). One IU is defined by the current WHO (World Health Organization) international standard (IS) for Factor VIII concentrate.

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Potency assignment for Kovaltry is determined using a chromogenic substrate assay. A field study involving 41 clinical laboratories from around the world measured recoveries of Kovaltry spiked into hemophilic plasma. The results of the field study indicated that the Factor VIII activity of Kovaltry can be accurately measured in plasma using either a one-stage clotting or chromogenic substrate assay according to routine methods of the testing laboratory.

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The required dose for a desired Factor VIII level expressed as IU/dL (or % of normal) can be estimated using the following formula:

Required dose (IU) = body weight (kg) x desir...