"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"...
Zemaira™ is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Zemaira™ 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 virus infections, and by inactivating and/or removing certain viruses during manufacture. (DESCRIPTION section for viral reduction measures.) The manufacturing procedure for Zemaira (alpha-proteinase inhibitor (human)) ™ 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 steps of the Zemaira (alpha-proteinase inhibitor (human)) ™ manufacturing process are pasteurization (60° C for 10 hours) and two sequential ultrafiltration steps. Additional purification procedures used in the manufacture of Zemaira (alpha-proteinase inhibitor (human)) ™ also potentially provide viral reduction. 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 Aventis Behring at 800-504-5434. The physician should discuss the risks and benefits of this product with the patient. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections (see Information For Patients).
General Infusion rates and the patients clinical state should be monitored closely during infusion. The patient should be observed for signs of infusion-related reactions.
As with any colloid solution, there may be an increase in plasma volume following intravenous administration of Zemaira (alpha-proteinase inhibitor (human)) ™. Caution should therefore be used in patients at risk for circulatory overload.
INFORMATION FOR PATIENTS
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur.
As with all plasma-derived products, some viruses, such as parvovirus B19, are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect pregnant women and immune-compromised individuals. Symptoms of parvovirus B19 include fever, drowsiness, chills, and runny nose followed two weeks later by a rash and joint pain. Patients should be encouraged to consult their physician if such symptoms occur.
Pregnancy Category C Animal reproduction studies have not been conducted with Zemaira (alpha-proteinase inhibitor (human)) ™. It is also not known whether Zemaira (alpha-proteinase inhibitor (human)) ™ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Zemaira (alpha-proteinase inhibitor (human)) ™ should be given to a pregnant woman only if clearly needed.
Nursing Mothers It is not known whether Zemaira™ is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Zemaira (alpha-proteinase inhibitor (human)) ™ is administered to a nursing woman.
Pediatric Use Safety and effectiveness in the pediatric population have not been established.
Geriatric Use Clinical studies of Zemaira (alpha-proteinase inhibitor (human)) ™ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. As for all patients, dosing for geriatric patients should be appropriate to their overall situation.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Zemaira Information
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