"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"...
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 (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. 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. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. 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.
Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) has been heat-treated in solution at 60°C for 10 hours in order to reduce the potential for transmission of infectious agents.1 No cases of hepatitis, either hepatitis B or hepatitis C, have been recorded to date in individuals receiving Prolastin (alpha) .18 However, as all individuals received prophylaxis against hepatitis B, no conclusion can be drawn at this time regarding potential transmission of hepatitis B virus.
- Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution.
- Administer only by the intravenous route.
- As with any colloid solution, there will be an increase in plasma volume following intravenous administration of Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) .23 Caution should therefore be used in patients at risk for circulatory overload.
- Prolastin (alpha) should be given alone, without mixing with other agents or diluting solutions.
- Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus 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 Prolastin (alpha) product in accordance with biohazard procedures.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenesis, mutagenesis, or impairment of fertility have not been conducted.
Pregnancy Category C
Animal reproduction studies have not been conducted with Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) w. It is also not known whether Prolastin (alpha) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Prolastin (alpha) should be given to a pregnant woman only if clearly needed.
It is not known whether Prolastin (alpha) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prolastin (alpha) is administered to a nursing woman.
Safety and effectiveness in the pediatric population have not been established.
18. Data on file.
23. Finlayson JS: Albumin products. Semin Thromb Hemost 6(2):85-120, 1980. 08937789 (Rev. January 2005)This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/6/2008
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