Novoeight

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

Medically reviewed by Drugs.com. Last updated on Jul 1, 2020.

Indications and Usage for Novoeight

Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation

factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for:

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On-demand treatment and control of bleeding episodes

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Perioperative management

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Routine prophylaxis to reduce the frequency of bleeding episodes

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

Novoeight Dosage and Administration

For intravenous injection after reconstitution only.

Dose

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

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Each vial of Novoeight contains the labeled amount of recombinant factor VIII in international units (IU). One IU of factor VIII activity corresponds to the quantity of factor VIII in one milliliter of normal human plasma. The calculation of the required dosage 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 two IU/dL. This relationship causes a factor of 0.5 to be present in the dose calculation formula shown below.

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The required dosage can be determined using the following formula:

Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5

The final dose calculated is expressed as IU

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Base the dose and frequency of Novoeight on the individual clinical response. Patients may vary in their pharmacokinetic and clinical responses