Antihemophilic Factor (recombinant), PEGylated-aucl

Class: Hemostatics
Brands: Jivi

Medically reviewed by Drugs.com on Sep 14, 2021. Written by ASHP.

Introduction

Antihemophilic factor (recombinant), PEGylated-aucl is a hemostatic.

Uses for Antihemophilic Factor (recombinant), PEGylated-aucl

Antihemophilic factor (recombinant), PEGylated-aucl has the following uses:

Antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Antihemophilic factor (recombinant), PEGylated-aucl has the following limitations of use:

Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for use in children < 12 years of age due to a greater risk for hypersensitivity reactions. Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for use in previously untreated patients (PUPs).

Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for the treatment of von Willebrand disease.

Antihemophilic Factor (recombinant), PEGylated-aucl Dosage and Administration

General

Antihemophilic factor (recombinant), PEGylated-aucl is available in the following dosage form(s) and strength(s):

• Lyophilized powder in single-use vials containing nominally 500, 1000, 2000, or 3000 IU.

Dosage

It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Pediatric Patients

For intravenous use after reconstitution only.

Dose

• Each vial label of antihemophilic factor (recombinant), PEGylated-aucl states the Factor VIII potency in international units (IU). One IU is defined by the current WHO (World Health Organization) international standard for Factor VIII concentrate.

• 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.

• Potency assignment for antihemophilic factor (recombinant), PEGylated-aucl is determined using a chromogenic substrate assay.

• Monitor the Factor VIII activity of antihemophilic factor (recombinant), PEGylated-aucl in plasma using either a validated chromogenic substrate assay or a validated one-stage clotting assay.

• Calculation of the required dose of Factor VIII is based on the empirical finding that 1 IU of Factor VIII per kilogram body weight increases the plasma Factor VIII level by 2 IU/dL.

• Estimate the required dose for on-demand treatment and control of bleeding and perioperative management using the following formula:

Required dose (IU) = body weight (kg) × desired...