"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"...
Koate-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 Talecris Biotherapeutics, 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.
- Koate (antihemophilic factor) -DVI is intended for treatment of bleeding disorders arising from a deficiency in factor VIII. This deficiency should be proven prior to administering Koate (antihemophilic factor) -DVI.
- Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution.
- Administer only by the intravenous route.
- Filter needle should be used prior to administering.
- Koate (antihemophilic factor) -DVI contains levels of blood group isoagglutinins which are not clinically significant when controlling relatively minor bleeding episodes. 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.
- Product administration and handling of the infusion set and needles must
be done with caution. Percutaneous puncture with a needle contaminated with
blood can transmit infectious viruses including HIV (AIDS) and hepatitis.
Obtain immediate medical attention if injury occurs.
Place needles in sharps container after single use. Discard all equipment including any reconstituted Koate (antihemophilic factor) -DVI product in accordance with biohazard procedures.
Pregnancy Category C
Animal reproduction studies have not been conducted with Koate (antihemophilic factor) -DVI. It is also not known whether Koate (antihemophilic factor) -DVI can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Koate (antihemophilic factor) -DVI should be given to a pregnant woman only if clearly needed.
Koate (antihemophilic factor) -DVI has not been studied in pediatric patients. Koate-HP, solvent/detergent treated Antihemophilic Factor (Human), has been used extensively in pediatric patients.
Spontaneous adverse event reports with Koate (antihemophilic factor) -HP for pediatric use were within the experience of those reports for adult use.
8. National Hemophilia Foundation Medical and Scientific Advisory Council. Hemophilia Information Exchange–AIDS Update: Recommendations concerning AIDS and the treatment of hemophilia HIV infection. Section I.G. (Rev. Jan., 1988).
9. Safety of therapeutic products used for hemophilia patients. MMWR 37(29):441–4, 449–50, 1988.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/20/2009
Additional Koate Information
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