Drug information of Factor VIII

Mechanism of effect

Factor VIII derived from pooled human plasma, temporarily replaces missing clotting factor VIII which corrects and/or prevents bleeding in patients with hemophilia A

 

Pharmacodynamic

Recombinant human antihemophilic factor

Temporarily replaces missing clotting factor VIII which corrects &/or prevents bleeding

Pharmacokinetics

Peak plasma concentration: 120±26 IU/dL

AUC: 1534±436 IU•hr/dL

Vd: 0.60±0.15 dL/kg
Total body clearance: 0.03±0.01 dL/kg/hr

Onset: Immediated (shortening of bleeding time)

Half-life: 8-28 hr

Dosage

Hemophilia A

Minor hemorrhage: 15 IU/kg loading dose to achieve FVIII:C plasma level ~30% of normal; THEN may administer half of loading dose qDay or q12hr for 1-2 days if a second infusion necessary

Moderate hemorrhage/minor surgery: 25 IU/kg loading dose to achieve FVIII:C plasma level ~50% of normal; THEN administer FVIII:C 15 IU/kg IVq8-12hr for 1-2 days to maintain plasma levels of FVIII:C at 30% of normal; repeat dose qDay or q12hr for up to 7 days or until adequate would healing achieved

Severe hemorrhage/major surgery: 40-50 IU/kg loading dose THEN administer FVIII:C 20-25 IU/kg IVq8-12hr to maintain plasma levels of FVIII:C at 80-100% of normal for 7 days; continue dose qDay or q12hr for up to 7 days to maintain FVIII: C levels at 30% to 50% normal

Drug contraindications

Hypersensitivity to this drug

Side effects

Diarrhea , Headache , nausea , vomiting , rash , vertigo , Dyspnea , urticaria , fever , Injection-site reaction , vasodilatation , somnolence , Arthralgia , hemorrhage , itching , nasal stuffiness , taste disturbance

Alerts

Use serial Factor VIII assays during treatment whenever possible to assure adequate Factor VIII levels are achieved and maintained

Some products may contain Willebrand factor for stabilization; efficacy not established for treatment of Willebrand disease

Clinical response to antihemophilic factor administration may vary; dosage must be individualized based on clinical response and coagulation studies, performed prior to treatment and regular intervals during treatment

Monitor for development of Factor VIII inhibitors

May form antibodies to mouse or hamster protein
Hypersensitivity to mouse or hamster protein, or intolerance or allergic reaction to any components

Administer at a rate <10 mL/min

Theoretical possibility of pathogen transmission

Risk of thromboembolic event increased with each use

Patient may develop neutralizing antibodies to factor VIII

Dose requirements will vary in patients with factor VIII inhibitors

Points of recommendation

IV Preparation

Reconstitute with the supplied sodium chloride diluent

Prevent excessive foaming

Gently rotate the vial to dissolve the powder

IV Administration

Administer using a single sterile disposable plastic syringe

Attach the syringe to the luer end of the infusion set tubing and perform venipuncture

Rate of administration should be determined by the pt's comfort level

Administer at 2 mL/min, with maximum rate of 10 mL/min

Monitor for tachycardia

Monitor Factor VIII levels

Storage

Refrigerate (Humate-P can be stored at room temp for up to 2 yr)

Protect from freezing

Protect from light

Pregnancy level

C

Breast feeding warning

Excretion in milk unknown; use with caution

Related drugs

Factor VII , coagulation factor x , Factor VIII , Factor X , Factor XIII

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