Presentation and Status in Health Basket
General Approach to Treatment and Assessment of Treatment Efficacy: It should be emphasized that the dosage of Koãte-DVI required for hemostasis must be individualized according to the needs of the patient, the severity of the deficiency, the severity of the hemorrhage, the presence of inhibitors, and the factor VIII level desired. It is often critical to follow the course of therapy with factor VIII level assays. The clinical effect of Koãte-DVI is the most important element in evaluating the effectiveness of treatment. It may be necessary to administer more Koãte-DVI than would be estimated in order to 5 attain satisfactory clinical results. If the calculated dose fails to attain the expected factor VIII levels, or if bleeding is not controlled after administration of the calculated dosage, the presence of a circulating inhibitor in the patient should be suspected. Its presence should be substantiated and the inhibitor level quantitated by appropriate laboratory tests. When an inhibitor is present, the dosage requirement for Antihemophilic Factor (Human) is extremely variable and the dosage can be determined only by the clinical response. Some patients with low titer inhibitors, (10 Bethesda units) can be successfully treated with factor VIII without a resultant anamnestic rise in inhibitor titer.12 Factor VIII levels and clinical response to treatment must be assessed to insure adequate response. Use of alternative treatment products, such as Factor IX Complex concentrates, Antihemophilic Factor (Porcine) or Anti-Inhibitor Coagulant Complex, may be necessary for patients with high titer inhibitors. Immune tolerance therapy using repeated doses of Factor VIII concentrate administered frequently on a predetermined schedule may result in eradication of the Factor VIII inhibitor.13,14 Most successful regimens have employed high doses of Factor VIII administered at least once daily, but no single dosage regimen has been universally accepted as the most effective. Consultation with a hemophilia expert experienced with the management of immune tolerance regimens is also advisable.
Pediatric Use: Koãte-DVI has not been studied in pediatric patients. Koãte-HP, solvent/detergent treated Antihemophilic Factor (Human), has been used extensively in pediatric patients. Spontaneous adverse event reports with Koãte-HP and Koãte-DVI for pediatric use were within the experience of those reports for adult use.
For full details see prescribing information.
Koãte-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Koãte-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia. Koãte-DVI contains naturally occurring von Willebrand’s factor, which is co-purified as part of the manufacturing process. Koãte-DVI has not been investigated for efficacy in the treatment of von Willebrand’s disease, and hence is not approved for such usage.
Note: Koãte-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807].The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to a patient. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. It is emphasized that hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis.8,9 Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative.
The risk of viral infectivity from this product cannot be totally eliminated. The presence of hepatitis viruses should be assumed. Intended for bleeding disorders arising from a deficiency in factor VIII. This deficiency should be proven prior to administering. Administer within 3 hours after reconstitution. Administer only by the intravenous route. When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored by means of hematocrit for signs of progressive anemia, as well as by direct Coombs’ tests. Should be given to a pregnant woman only if clearly needed.
For full details see prescribing infotmation.
Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations.10,11 Ten adverse reactions related to 7 infusions were observed during a total of 1053 infusions performed during the clinical study of Koãte-DVI, for a frequency of 0.7% infusions associated with adverse reactions. All reactions were mild and included paraesthesia, vision blurred, headache, nausea, abdominal pain, and feeling jittery.
Pregnancy and Lactation
Animal reproduction studies have not been conducted with Koãte-DVI. It is also not known whether Koãte-DVI can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Koãte-DVI should be given to a pregnant woman only if clearly needed.