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warnings
WARNINGS Because Factor IX Complex, Profilnine SD is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma to the application of viral elimination/reduction steps such as DEAE chromatography and solvent detergent treatment in the manufacturing process. 9-10 Despite these measures, such product can potentially transmit disease, therefore the risk of infectious agents cannot be totally eliminated. The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections. Scientific opinion encourages hepatitis B and hepatitis A vaccinations for patients with hemophilia at birth or diagnosis. In patients undergoing surgery and in patients with known liver disease, thrombosis or disseminated intravascular coagulation (DIC) are serious and potentially fatal adverse reactions associated with the administration of Factor IX Complex concentrates. 11-13 Infrequent but consistent reports have been described which indicate that patients are at greater risk of developing thrombosis and DIC in the period following surgery. Cases have also been cited which indicate that patients with liver disease may be predisposed to thrombosis or DIC when treated with Factor IX Complex. Although the available data is limited, Profilnine SD should only be administered to patients when the beneficial effects of use outweigh the serious risk of potential hypercoagulation.
ADVERSE REACTIONS Adverse reactions characterized by either thrombosis or disseminated intravascular coagulation (DIC) are associated with administration of Factor IX Complex concentrates. 11-14 In particular, patients who receive prolonged treatment with Factor IX Complex concentrates postoperatively or with known liver disease should be kept under close observation for signs or symptoms of intravascular coagulation. Continued administration should be left to the discretion of the physician. Adverse reactions may include urticaria, fever, chills, nausea, vomiting, headache, somnolence, lethargy, flushing or tingling. For most reactive individuals, slowing the rate of infusion relieves the symptoms. For those highly reactive individuals, a different lot may be satisfactory. To report SUSPECTED ADVERSE REACTIONS, contact Grifols at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .