"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, 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 (See CLINICAL PHARMACOLOGY). Despite these measures, such products can still potentially transmit disease. 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. 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 the U.S. distributor, Nabi®, at 1-800-327-7106. The physician should discuss the risks and benefits of this product with the patient. Physicians should also report adverse reactions or any disease condition which may occur concomitantly with the administration of this product to the U.S. distributor, Nabi®.
If the infusion of the concentrate occurs more than 1 hour following reconstitution, there may be increased prekallikrein activator (PKA) with consequent hypotension.
Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women, or immune-compromised individuals.
Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.
Certain components used in the packaging of this product contain natural rubber latex.
Identification of the clotting deficiency as that caused by the presence of Factor VIII inhibitors is essential before the administration of Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, is initiated.
Signs and/or symptoms of hypotension may occur with this product. In these cases, stopping the infusion allows the symptoms to disappear. With all but the most reactive individuals, the infusion may be resumed at a slower rate.
If clinical signs of intravascular coagulation occur, the infusion should be stopped promptly and the patient monitored for DIC by the appropriate laboratory tests. Symptoms of DIC include changes in blood pressure and pulse rate, respiratory distress, chest pain and cough. Laboratory indications of DIC include prolonged thrombin time, prothrombin time and partial thromboplastin time tests. Other indications of DIC are decreased fibrinogen concentration, decreased platelet count and/or the presence of fibrinogen/fibrin degradation products.
In some cases, laboratory tests such as the activated partial thromboplastin time test may not correlate with clinical response, in that the appearance of hemostatic improvement may occur without a reduction of partial thromboplastin time. However, the prothrombin time would be expected to be shortened.
In children, fibrinogen levels should be determined prior to the initial infusion and monitored during the course of the treatment.
Pregnancy Category C. Animal reproduction studies have not been conducted with Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated. It is also not known whether Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, should be given to a pregnant woman only if clearly needed.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/13/2009
Additional Autoplex-T Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.