Alphanate Special Precautions

Thromboembolic Events: Thromboembolic events have been reported in von Willebrand Disease patients receiving Antihemophilic Factor/von Willebrand Factor Complex replacement therapy, especially in the setting of known risk factors for thrombosis. Early reports might indicate a higher incidence in females. In addition, endogenous high levels of FVIII have also been associated with thrombosis but no causal relationship has been established. In all VWD patients in situations of high thrombotic risk receiving coagulation factor replacement therapy, caution should be exercised and antithrombotic measures should be considered.
Infections: Because Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate 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. 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. Incubation in a solvent detergent mixture during the manufacturing process is designed to reduce the risk of transmitting viral infection. However, medical opinion encourages hepatitis A and hepatitis B vaccinations for patients with hemophilia at birth or at the time of diagnosis.
Nursing personnel, and others who administer this material, should exercise appropriate caution when handling due to the risk of exposure to viral infection.
Inhibitor Formation: Some patients develop inhibitors to Factor VIII. These inhibitors are circulating antibodies (i.e., globulins) that neutralize the procoagulant activity of Factor VIII. No studies have been conducted with Alphanate 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/von Willebrand Factor Complex (Human), or the response may be much less than would otherwise be expected; therefore, larger doses of Antihemophilic Factor/von Willebrand Factor Complex (Human) are often required. The management of bleeding in patients with inhibitors requires careful monitoring, especially if surgical procedures are indicated.
Reports in the literature suggest that patients with Type 3, severe von Willebrand Disease, may occasionally develop alloantibodies to von Willebrand factor after replacement therapy. The risk of developing alloantibodies in patients with von Willebrand disease due to the use of this product is not known.
Information for Patients: Patients should be informed of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur.
Patients should be informed of a potential for viral infection such as parvovirus B19 or hepatitis A. Parvovirus B19 may most seriously affect seronegative pregnant women, or immunocompromised individuals. Patients should report any signs and symptoms of fever, sore throat, or joint soreness to the physician immediately.
Use in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with Alphanate. It is also not known whether Alphanate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Alphanate should be given to a pregnant woman only if clearly needed.
Use in Children: Hemophilia A Indication: Clinical trials for safety and effectiveness in pediatric Hemophilia A patients 16 years of age and younger have not been conducted. During a well controlled half-life and recovery clinical trial in patients previously treated with Factor VIII concentrates for Hemophilia A, the single pediatric patient receiving Alphanate (solvent detergent non-heat treated) responded similarly when compared with 12 adult patients. No adverse events were reported in either pediatric or adult patients with Alphanate.
VWD Indication: Fifteen pediatric patients with von Willebrand Disease younger than 18 years of age were treated with non-heat (A-SD) and heat-treated (A-SD/HT) Alphanate during the course of clinical studies. In the retrospective study, five patients younger than 18 years of age were treated with heat-treated (A-SD/HT) Alphanate.