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DESCRIPTION Factor IX Complex, Konyne (factor ix complex) ® 80, heat-treated at 80°C for 72 hours, is a sterile, dried, plasma fraction comprising coagulation factors II, IX, X and low levels of factor VII. Nomenclature Factor: Synonyms: II prothrombin VII proconvertin IX plasma thromboplastin component, PTC, Christmas factor X Stuart-Prower factor Konyne (factor ix complex) 80 is standardized in terms of factor IX content and each vial of Konyne (factor ix complex) 80 is labeled for factor IX. One international unit (IU) of factor IX as defined by the World Health Organization standard for blood coagulation factor IX is approximately equal to the level of factor IX found in 1.0 mL of fresh, normal plasma. The factor IX content is approximately 50 times purified over whole plasma, and when reconstituted as directed, Konyne (factor ix complex) 80 contains 25 times as much factor IX as an equal volume of fresh plasma. Konyne 80, containing approximately 1000 IU of factor IX administered in 40 mL, contains the factor IX content of 1 liter of fresh plasma. Konyne (factor ix complex) 80 must be administered intravenously.

PATIENT INFORMATION 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 2 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.

OVERDOSE Symptoms include disseminated intravascular coagulation (DIC). CONTRAINDICATIONS Liver disease with signs of intravascular coagulation or fibrinolysis, not for use in factor VII deficiencies, patients undergoing elective surgery.

SIDE EFFECTS In some patients the rapid administration of Konyne (factor ix complex) 80 can cause transient fever, chills, headache, flushing or tingling. DRUG INTERACTIONS Increased toxicity: Do not coadminister with aminocaproic acid may increase risk for thrombosis.

WARNINGS 1. Hepatitis and Viral Diseases Konyne (factor ix complex) 80 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 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. 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 Bayer Corporation [1-888-765-3203]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. It is emphasized that hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis. 19,20 Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative. 2 Thrombosis Cases of patients developing postoperative thrombosis after treatment with Factor IX Complex have been described. Although thrombosis is a well-known risk of the postoperative period, it is found to be greater in these patients. 13-15 No other data are presently available. Until further surveys and more conclusive studies are available, Konyne (factor ix complex) 80 is only advised for patients undergoing elective surgery where the expected beneficial effects of its use outweigh the increased risk of the possibility of thrombosis. This applies especially to those who may be predisposed to thrombosis. Do not use in cases of known liver disease where there is any suspicion of intravascular coagulation or fibrinolysis. PRECAUTIONSGeneral Reconstitute only with Sterile Water for Injection, USP. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution. Administer only by the intravenous route. The administration equipment and any reconstituted Factor IX Complex, Konyne (factor ix complex) ® 80 not immediately used should be discarded. E-aminocaproic acid should not be administered with Factor IX Complex as this may increase the risk of thrombosis. Patients who receive Konyne (factor ix complex) 80 either postoperatively or with known liver disease should be kept under close observation for signs and symptoms of intravascular coagulation or thrombosis. Any suspicious findings of this nature indicate the dosage should be markedly decreased if the patient's conditions are such that the treatment cannot be discontinued entirely. In the event of thrombohemorrhagic disorders occurring, reduction in dosage should be considered, and treatment with heparin may be warranted. Although this preparation does not contain heparin, it has been suggested that reconstitution with heparin in a concentration of 2-5 IU per mL may reduce the risk of development of thrombosis. 17 However, thrombosis can occur even in the presence of heparin. Patients receiving Konyne (factor ix complex) 80 for prolonged periods should be continually monitored at least for levels of factors II, IX and X. The same comments as in No. 6 above are indicated. Half-lives of factors II and X are considerably longer than the half-life of factor IX. Hence frequent repeated high-dose administration may result in build-up of factors II and X, with increasing risk of thrombotic side effects. Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses 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 Konyne (factor ix complex) 80 product in accordance with biohazard procedures. Pregnancy Category C Animal reproduction studies have not been conducted with Konyne (factor ix complex) 80. It is also not known whether Konyne (factor ix complex) 80 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Konyne (factor ix complex) 80 should be given to a pregnant woman only if clearly needed. Information for 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 2 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.