"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"...
PROPLEX T, Factor IX 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. There is also the possibility that unknown infectious agents may be present in such products. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jacob 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 Baxter Healthcare Corporation at 1-800-423-2862. The physician should discuss the risks and benefits of this product with the patient.
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 deficiency as one of either Factor IX, Factor VII or Factor VIII with inhibitors is essential before administration of the PROPLEX T, Factor IX Complex, Heat Treated is initiated.
With the exception of its use in treating hemarthroses occurring in Factor VIII-inhibitor patients, no benefits may be expected from this product in treating deficiencies other than those of Factor IX or Factor VII.
Caution: It is important that the dosage regimen chosen is carefully evaluated with respect to the entire spectrum of factors present in this product. Levels of Factors II, IX and X should be monitored during therapy to prevent unnecessarily high levels of these factors, which may increase the risk of intravascular coagulation. PROPLEX T, Factor IX Complex, Heat Treated is prepared by calcium phosphate absorption of cold ethanol precipitated material and therefore, contains higher ratios of Factor VII and Factor X to Factor IX than products prepared by cationic exchange.14
The use of high doses of prothrombin complex concentrates has been reported to be associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.1, 12, 15, 16
If signs of intravascular coagulation, thrombosis, or emboli occur, which include changes in blood pressure and pulse rate, respiratory distress, chest pain and cough, the infusion should be stopped promptly. In general, the risk of enhancing DIC may be reduced by raising the patient's Factor VII or Factor IX level to not more than about 50% of normal. If the need exists to raise the patient's Factor IX or Factor VII level higher than 50% of normal, the physician should monitor infusion of material to detect signs and symptoms of DIC.
Special caution should be taken in the use of this concentrate in newborns, where a higher morbidity and mortality may be associated with hepatitis, and in individuals with pre-existing liver disease.
Since the dosage of PROPLEX T, Factor IX Complex, Heat Treated is calculated on the basis of its potency, frequent laboratory tests to monitor the effectiveness of treatment usually are unnecessary. This is particularly true for single dose treatment of an uncomplicated hemarthrosis. However, if a major bleeding episode is being treated in the hospital, or if adequate hemostatic levels of Factor VII or Factor IX are needed to permit performance of surgery, Factor VII or Factor IX assays should be performed at least once a day, prior to infusion, to ensure that the daily dose of PROPLEX T, Factor IX Complex, Heat Treated is sufficient to maintain adequate levels of the desired clotting factor.
Pregnancy (Category C). Animal reproduction studies have not been conducted with PROPLEX T, Factor IX Complex, Heat Treated. It is also not known whether PROPLEX T, Factor IX Complex, Heat Treated can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PROPLEX T, Factor IX Complex, Heat Treated should be given to a pregnant woman only if clearly needed.
1. White GC, Lundblad RL, Kingdon HS: Prothrombin complex concentrates: Preparation, properties and clinical uses. Curr Top Hematol 2:203-244, 1979
12. Lusher JM, Shapiro SS, Palascak JE, et al: Efficacy of prothrombin-complex concentrates in hemophiliacs with antibodies to Factor VIII. A multicenter therapeutic trial. New Eng J Med 303:421-425, 1980
14. Aronson DL: Factor IX complex. Semin Thromb Hemostas VI:28-43, 1979
15. Fuerth JH, Mahrer P: Myocardial infarction after Factor IX therapy. JAMA 214: 1455-1456, 1981
16. Abildgaard CF: Hazards of prothrombin-complex concentrates in treatment of hemophilia. New Eng J Med 304:670, 1981This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/5/2009
Additional Proplex-T Information
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