"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"...
Monoclate-P® is made from human blood. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Monoclate-P® 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. 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 viral infections and inactivating and/or removing certain viruses during manufacture (see DESCRIPTION section for viral reduction measures). The manufacturing procedure for Monoclate-P® (antihemophilic factor) includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. The primary viral reduction step of the Monoclate-P® (antihemophilic factor) manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Monoclate-P® (antihemophilic factor) also provides viral reduction capacity. Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents can not be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 800-504-5434 (in the U.S. or Canada).
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections (see PATIENT INFORMATION).
Most Antihemophilic Factor (Human) concentrates contain naturally occurring blood group specific antibodies. However, the processing of Monoclate-P® (antihemophilic factor) significantly reduces the presence of blood group specific antibodies in the final product. Nevertheless, when large or frequently repeated doses of product are needed, patients should be monitored by means of hematocrit and direct Coombs tests for signs of progressive anemia.
Formation of Antibodies to Mouse Protein
Although no hypersensitivity reactions have been observed, because Monoclate-P® (antihemophilic factor) contains trace amounts of mouse protein ( ≤ 50 ng per 100 I.U. of AHF), the possibility exists that patients treated with Monoclate-P® (antihemophilic factor) may develop hypersensitivity to the mouse proteins.
Pregnancy Category C
Animal reproduction studies have not been conducted with Monoclate-P® (antihemophilic factor) . It is also not known whether Monoclate-P® (antihemophilic factor) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Monoclate-P® (antihemophilic factor) should be given to a pregnant woman only if clearly needed.
The safety and effectiveness of Monoclate-P® (antihemophilic factor) for the treatment of hemophilia A has been demonstrated in 33 pediatric patients. As in adults, pediatric patients should be dosed based upon weight (see DOSAGE AND ADMINISTRATION).
Clinical studies of Monoclate-P® (antihemophilic factor) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dosing should be appropriate to the clinical situation.
Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Monoclate-P Information
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