"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Because Antihemophilic Factor (Human), Alphanate (antihemophilic factor) ® is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma, through the application of viral elimination/reduction steps such as solvent detergent and heat treatment in the manufacturing process. Despite these measures, such products can still potentially transmit disease; therefore, the risk of infectious agents cannot be totally eliminated. All infections thought by a physician possibly to have been transmitted by this product should be reported to the manufacturer at 1-888-675-2762 (US) or 1-323-225-9735 (International). The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.8-9 Incubation in a solvent detergent mixture during the manufacturing process is designed to reduce the risk of transmitting viral infection.8,9 However, scientific opinion encourages hepatitis A and hepatitis B vaccinations for patients with hemophilia at birth or at the time of diagnosis.
Antihemophilic Factor (Human), Alphanate (antihemophilic factor) ®, should not be administered at a rate exceeding 10 mL/minute. Rapid administration of a Factor VIII concentrate may result in vasomotor reactions.
Some patients develop inhibitors to Factor VIII. Factor VIII inhibitors are circulating antibodies (i.e., globulins) that neutralize the procoagulant activity of Factor VIII. No studies have been conducted with Alphanate (antihemophilic factor) ® to evaluate inhibitor formation. Therefore, it is not known whether there are greater, lesser or the same risks of developing inhibitors due to the use of this product than there are with other antihemophilic factor preparations. Patients with these inhibitors may not respond to treatment with Antihemophilic Factor (Human), or the response may be much less than would otherwise be expected; therefore, larger doses of Antihemophilic Factor (Human) are often required. The management of bleeding in patients with inhibitors requires careful monitoring, especially if surgical procedures are indicated.10-12
Nursing personnel, and others who administer this material, should exercise appropriate caution when handling due to the risk of exposure to viral infection. Discard any unused contents into the appropriate safety container. Discard administration equipment after single use into the appropriate safety container. Do not resterilize components.
Pregnancy Category C
Animal reproduction studies have not been conducted with Alphanate (antihemophilic factor) ®. Therefore, it is not known whether it can cause fetal harm when administered to a pregnant woman or affect the reproductive capacity of a woman. Alphanate (antihemophilic factor) ® should be given to a pregnant woman only if clearly needed.
Clinical trials for safety and effectiveness in pediatric patients 16 years of age and younger have not been conducted. Across well controlled half-life and recovery clinical trial in patients previously treated with Factor VIII concentrates for Hemophilia A, the one pediatric patient receiving Alphanate (antihemophilic factor) ® (solvent detergent) responded similarly when compared with 12 adult patients.4 No adverse events were reported in either pediatric or adult patients with Alphanate (antihemophilic factor) ®.4
4. Data on file at Grifols Biologicals Inc.
8. Biggs, R. Jaundice and Antibodies Directed Against Factors VIII and IX in Patients Treated for Haemophilia or Christmas Disease in the United Kingdom. Br J Haematol 1974, 26:313-329.
9. Kasper, C.K., Kipnis, S.A. Hepatitis and Clotting Factor Concentrates. JAMA 1972,221:510.
10. Kasper, C.K. Incidence and Course of Inhibitors Among Patients with Classic Hemophilia. Thromb Diath Haemorrh (Stuttg) 1973, 30:263-271.
11. Rizza, C.R., Biggs, R. The Treatment of Patients Who Have Factor VIII Antibodies. Br ] Haematol 1973, 24:65-82.
12. Roberts, H.R., Knowles, M.R., Jones, T.L., McMillan, C. The Use of Factor VIII in the Management of Patients with Factor VIII Inhibitors. In: Brinkhous, K.M., ed. Hemophilia and New Hemorrhagic States, International Symposium, New York, University of North Carolina Press, 1970, pp.152-163.
Last reviewed on RxList: 11/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Alphanate Information
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