Name:Anti-Inhibitor Coagulant Complex Concentrates
Porcine Factor VIII

Anti-Inhibitor Coagulant Complex (AICC)
FEIBA VH - Baxter Healthcare Corp., Glendale, CA Autoplex T - Nabi, Boca Raton, FL

Antihemophilic Factor [Porcine]
Hyate: C - Ipsen, Inc., Milford, MA

Description/Contents: Autoplex T and FEIBA VH are anti-Inhibitor Coagulant Complex (AICC) products prepared from pooled human plasma by Cohn fractionation (fraction II + III ). They contain variable amounts of activated and precursor vitamin K dependent clotting factors II, VII, IX, X. Traces of Factor VIII and factors of the kinin generating system are also present. Autoplex T may also contain traces of heparin. Efficacy is thought to be due to the presence of activated factor VIIa and Xa. Effective viral inactivation of enveloped and non-enveloped viruses is achieved by heating Autoplex T for 6 days at 60oC; or, in the case of FEIBA VH, by vapor heating under pressure (10 hours at 60oC and 190 mbar followed by 1 hour at 80oC at 370 mbar). Hyate:C is a highly purified porcine antihemophilic factor VIII derived from pooled porcine plasma and containing minimal amounts of porcine von Willebrand Factor. The product is not virally attenuated; however, the source plasma is extensively screened by cell culture and PCR techniques for porcine parvovirus and other viruses. It has not been shown to transmit any known viral diseases.

• AICC and Porcine Factor VIII are indicated for the treatment of congenital Hemophilia A patients who are bleeding or undergoing surgery, in the presence of demonstrated moderate or high titer inhibitors. AICC may also be used in Hemophilia B patients under similar circumstances.
  Porcine Factor VIII and AICC may be considered for the primary treatment of acquired hemophilia A with inhibitor autoantibodies

• Inhibitor levels should be determined as measured in Bethesda units (B.U.). Products are indicated in patients with a history or present level of inhibitor of >10 B.U. Patients with inhibitors in the 2-10 B.U. range may receive either high dose antihemophilic factor (AHF) or anti-inhibitor therapy.

• Porcine Factor VIII shows low-level cross-reactivity with human Factor VIII (approx. 15%). Patients with extremely high inhibitor levels to human factor VIII (>50 B.U.) should have their inhibitors directly measured against porcine factor VIII. Porcine factor VIII has not been shown to be effective when anti-porcine factor VIII titers are > 20 B.U.

• AICC is contraindicated in patients with signs of disseminated intravascular coagulation (DIC) or fibrinolysis. Porcine factor VIII is contraindicated in patients who have had prior anaphylactic responses to this product.

Dosage and Administration: FEIBA VH is standardized in arbitrary IMMUNO units, based on its ability to provide 50% correction of the aPTT test using a standard high titer inhibitor serum. Dosage is 50 – 100 IMMUNO units/kg of body weight intravenously, depending on the severity of bleeding. Dosage may be repeated after 6 hours. Daily dosage should not exceed 200 IMMUNO units per kg per day.

Autoplex T is standardized in arbitrary Hyland factor VIII correctional units and is administered intravenously. Dosage is 25 – 100 Hyland correctional units/kg of body weight, depending on the severity of bleeding. Dosage may be repeated after 6 hours.

Laboratory tests used to control efficacy, such as aPTT, PT, INR and whole blood clotting time may not correlate with therapeutic efficacy of AICC and should not be used to determine dosage.

Porcine factor VIII initial dose is 100-150 porcine factor VIII units/kg. Response should be assessed by pre- and post-treatment factor VIII levels. In the absence of an adequate response, dosage may be repeated immediately. Once therapeutic effect has been attained, subsequent doses should be repeated every 6-8 hours.

Complications: Viral transmission: Autoplex T and FEIBA VH are produced from pooled human plasma and carry the theoretical risk of disease transmission. Viral inactivation effectively reduces this risk and there have been no reports of HIV or Hepatitis A, B or C transmission by these products as currently formulated.

Porcine Factor VIII is produced from pooled porcine plasma and carries the risk of porcine viral contamination. To date, no evidence of such transmission has been documented.

Immunologic reactions: Allergic reactions, including anaphylactic responses, have been documented to both AICC and porcine factor VIII. Anamnestic reactions to residual Factor VIII in AICC occur, are more common with FEIBA VH than Autoplex T, and may be seen in up to 20% of treated patients.

Immune responses to porcine factor VIII may cross-react with human factor VIII, leading to an anamnestic response.

Thrombogenicity: Myocardial infarction and DIC have been documented after AICC treatment. These reactions are rare, but are more frequent with high dose or repeated therapy and in patients with underlying liver disease or thrombotic risk factors.

Thrombocytopenia: Acute thrombocytopenia has rarely been reported with porcine factor VIII therapy. Monitoring may be advised. This responds rapidly to termination of therapy.

Alternative Therapy:
Factor VIIa (NovoSeven)
Factor IX Complex

Penner JA. Management of hemophilia in patients with high-titer inhibitors: focus on the evolution of activated prothrombin complex concentrate AUTOPLEX T. Hemophilia 1999;5 (suppl. 3): 1-9.

Green D. Complications associated with the treatment of hemophiliacs with inhibitors. Hemophilia 1999; 5 (suppl. 3): 11-17.

Brettler DB, Forsberg AD, Levine PH, et al. The use of porcine factor VIII concentrate (Hyate:C) in the treatment of patients with inhibitor antibodies to factor VIII: A multicenter US experience. Arch Intern Med 1989;149:1381-5.

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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