Antihemophilic Factor (recombinant), Glycopegylated-exei
Class: Hemostatics
Chemical Name: Human coagulation factor VIII-(1-750)-(1638-1648)-peptide compound with human coagulation factor VIIIa light chain, glycosylated and pegylated
CAS Number: 1309086-46-1
Brands: Esperoct
Introduction
Antihemophilic factor (recombinant), glycopegylated-exei is a hemostatic.
Uses for Antihemophilic Factor (recombinant), Glycopegylated-exei
Antihemophilic factor (recombinant), glycopegylated-exei has the following uses:
Antihemophilic factor (recombinant), glycopegylated-exei is a coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A 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), glycopegylated-exei is not indicated for the treatment of von Willebrand disease.
Antihemophilic Factor (recombinant), Glycopegylated-exei Dosage and Administration
General
Antihemophilic factor (recombinant), glycopegylated-exei is available in the following dosage form(s) and strength(s):
For injection: nominally 500, 1000, 1500, 2000, or 3000 international units (IU or unit), lyophilized powder in single-dose vials for reconstitution.
Dosage
It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
For intravenous infusion after reconstitution only.
Dosage and duration of treatment depend on the severity of the Factor VIII deficiency, on the location and extent of bleeding, and on the patient’s clinical condition. Careful monitoring of replacement therapy is necessary in cases of major surgery or life-threatening bleeding episodes.
Each vial of antihemophilic factor (recombinant), glycopegylated-exei contains the labeled amount of recombinant Factor VIII in international units (IU or unit). One unit 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 unit of Factor VIII per kg body weight raises the plasma Factor VIII activity by two IU/dL.
Antihemophilic factor (recombinant), glycopegylated-exei may be dosed to achieve a specific target Factor VIII activity level, depending on the severity of hemophilia, for on-demand treatment/control of bleeding episodes or perioperative management. To achieve a specific target Factor VIII activity level, use the following formula:
Dosage (units) = Body Weight (kg) × Desired Factor VIII Increase (units/dL or % normal) × 0.5
Base the dose and frequency of antihemophilic factor (recombinant), glycopegylated-exei on the individual clinical response. Patients may vary in their pharmacokinetic and clinical responses.
If monitoring of Factor VIII activity is performed, use a chromogenic or one-stage clotting assay appropriate for use with antihemophilic fac...
