Name: Factor VIIIC AHF (Antihemophilic Factor)
Factor VIII vWF (von Willebrand Factor)

Factor VIII (Recombinant)
ReFacto - Genetics Institute, Inc., Cambridge, MA
Helixate FS - Aventis Behring LLC, Kankakee, IL
Kogenate FS - Bayer Corp., Elkhart, IN
Recombinate - Baxter Healthcare Corp., Glendale, CA

Factor VIII, Human (Plasma Derived and Monoclonal Antibody Purified)
Hemofil M - Baxter Healthcare Corp., Glendale, CA
Monarc-M - American Red Cross, Washington, DC
Monoclate-P - Aventis Behring, LLC., Kankakee, IL

Factor VIII, Human (Plasma Derived with Factor VIII:C and Factor VIII/ vWF)
Humate-P - Aventis Behring LLC., Kankakee, IL
Koate-DVI - Bayer Corp., Elkhart, IN
Alphanate - Alpha Therapeutic Corp., Los Angeles, CA

• Treatment of Hemophilia A
  All of the products above may be used to treat hemophilia A. From a recipient safety viewpoint, recombinant products are the first choice. Plasma-derived products that are heat-treated and monoclonal-antibody purified are safe and effective and are considered to be free of HIV and hepatitis viruses. The use of cryoprecipitated AHF or FFP for the treatment of hemophilia A is not acceptable practice if plasma derived or recombinant AHF is available.

  Replacement therapy with Factor VIII:C products is indicated for patients with hemophilia A with joint hemorrhages or other bleeding episodes, following trauma, or in preparation for elective or emergent surgery.

• Treatment of von Willebrand Disease
  Humate-P is licensed for the treatment of von Willebrand disease in adults and children with spontaneous or trauma-induced bleeding when desmopressin is known or suspected to be inadequate. Alphanate and Koate-DVI contain variable amounts of vWF activity and are sometimes used empirically for this purpose when Humate-P is not available, although they are not FDA licensed for this indication.

Dosage and Administration: IV administration only. The maximum rate of administration is product dependent. See package insert for administration and laboratory monitoring details.

Hemophilia A:
The circulating half-life of factor VIII is 10-12 hours, but in the first 36-48 hours post-op or post-life-threatening trauma, the rate of factor consumption is relatively high. In such cases an every 8-hr schedule should be maintained.

Dosage is based on the desired factor VIII:C increase (%): A 100% AHF level is 1 international unit (IU) of Factor VIII:C per ml of plasma (1.0 IU/ml). Most bleeding is successfully treated if levels are >30% of normal. In life-threatening or surgical situations, initiate therapy to achieve 100% level and adjust so that the expected level 8 hours after infusion does not fall below 50% during the treatment schedule.

One can assume that 1 IU of Factor VIII/kg body weight will increase the patient’s level by 2% (0.02 IU/ml). Therefore, if the patient’s level is 1% or less (0.01 IU/ml), which is true in severe hemophilia, a dose of 40 IU/kg body weight will raise the level to 80%, in the absence of any inhibitors.

Dosage and desired level of AHF vary depending upon the nature of the bleeding (hemarthrosis, intramuscular, neurological, surgical, etc) and hematologic or transfusion medicine consultation is strongly recommended.

Initiate therapy when the following criteria are met: Patient has diagnosis of hemophilia A and has bleeding or physical trauma or surgery is anticipated. A hemophilia patient can tell when he is bleeding; do NOT do joint aspirations or other invasive diagnostic procedures to decide on therapy. Treat until bleeding stops and/or cause has been ameliorated, usually 1- 2 days following a joint hemorrhage, 7 to 10 days after soft tissue trauma or surgery.

von Willebrand Disease:
Humate-P is labeled with both factor VIII:C and von Willebrand factor/Ristocetin cofactor activity (vWF:RCof) levels. In von Willebrand disease, expected levels of recovery are 1.5 IU/dL rise per IU/kg vWF:RC of administered. 40-80 IU vWF:RCof per kg body weight given every 8-12 hours would be expected to lead to 100% replacement of circulating levels of von Willebrand factor. See package insert for detailed dosing information.

Contraindications:Hypersensitivity to mouse (Monoclate-P, Monarc-M, Hemofil M) or hamster (Helixate FS, Kogenate FS, Recombinate) protein.

Humate-P may contain trace amounts of Anti A and Anti B isoagglutinins with a consequent small risk of a positive DAT or hemolysis after infusion.

Patients with hemophilia A and factor inhibitors should not receive additional AHF and require highly specialized treatment. See other sections of these Guidelines (FEIBA, NovoSeven, Porcine AHF) for details. Treatment of acquired circulating anticoagulants in hemophilia patients, or appearing spontaneously in patients with Waldenstrom’s, lymphoma or immunologic disease, is complex and should not be undertaken without specific consultation.

Alternative Therapy: None.

National Hemophilia Society, Medical and Scientific Advisory Committee Recommendations Concerning the Treatment of Hemophilia and Other Bleeding Disorders (Revised March 2003)

Lusher JM. Congenital disorders of clotting proteins and their management, in Rossi’s Principles of Transfusion Medicine, Third edition, 2002. Ed. Simon, Dzik, Snyder, et al; pp. 448-462, Lippincott, Williams and Williams, Philadelphia.

Transfusion Guidelines

Plasma Guidelines	Antithrombin III Guidelines
Platelet Guidelines	Activated Protein Guidelines
Red Cell Guidelines	Factor IX Guidelines
Cryoprecipitate Guidelines	Factor VIII Guidelines
AICC/Porcine Factor VIII Guidelines	IVIG Guidelines Coagulation Factor VII Guidelines

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