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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.
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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.
Factor IX Complex, Konyne (factor ix complex) ® 80 is indicated for the prevention and control of bleeding caused by Factor IX deficiency due to hemophilia B.
Konyne (factor ix complex) 80 is not indicated for use in the treatment of factor VII deficiency.
Konyne (factor ix complex) 80 is appropriate for use in:
Note: For publications on the clinical use of Konyne (factor ix complex) ®, please refer to references 1,2, 6-17.
Each bottle of Konyne 80 has the factor IX activity, in IU, stated on the bottle label. One IU is defined as the activity present in 1 mL of fresh, normal plasma. The potency is standardized in terms of factor IX content.
The amount of Konyne (factor ix complex) 80 required for normalizing hemostasis will depend upon the patient and upon the circumstances. Sufficient Konyne (factor ix complex) 80 should be administered to achieve and maintain a plasma level of at least 20% until hemostasis is achieved.
Levels of factor IX of 30 to 40 percent are considered effective in stopping hemorrhages. 1 Bleeds in life- or limb-threatening areas require factor IX levels of 50 to 80 percent which should be maintained at 30 to 40 percent for a few days. 1 The desired hemostatic plasma level in surgical patients for minor procedures or invasive dental surgery is between 30 and 40 percent of normal. 1 This can be achieved by a dosage not exceeding 30 to 40 units per kg body weight. In major hemorrhage, as during surgery or severe accidental trauma, plasma levels of 60 to 80 percent just prior to surgery, maintained above 30 percent for a further 5 to 7 days and then above 15 to 20 percent for 7 to 10 additional days, until healing occurs, are required. 1
While the range of values in normal clinical practice is likely to vary depending upon differences between patients, their clinical condition and the type of assay employed, it is again stressed that high dosages, especially if frequently repeated (e.g., more than once per day) are hazardous. Such regimens can induce major thrombotic complications and hence must be avoided.
The following formulas may be used as guidelines to calculate an appropriate dose or to estimate the expected percentage increase obtained from a given dose:
| Expected factor IX = IU administered x 1.0 increase (in % of normal) body weight (in kg) |
| IU required = body weight (kg) x desired factor IX increase (% normal) x 1.0 |
Thus, in order to bring a 70 kg patient from 0% to 50% of normal, the patient would require 70 x 50 x 1.0 = 3500 IU or 50 IU/kg body weight.
The ideal treatment for proven congenital deficiency of procoagulants is prophylactic administration. For prophylaxis against hemorrhage during times of extensive physical activity, the plasma factor IX levels should be raised to 15 to 30 percent. Maintenance dosage should be adapted to the individual patient's needs. Additional Factor IX Complex, Konyne (factor ix complex) ® 80 should be administered when a patient on prophylaxis is exposed to trauma or surgery.
Maintenance dosage should be administered according to the clinical response and the factor IX level achieved. Such dosage is usually about 10-20 IU per kg body weight per day.
For treatment of bleeding episodes in patients with hemophilia A (factor VIII deficiency) who have inhibitors to factor VIII, the recommended dose should be 75 IU/kg. A second dose may be administered after 12 hours if necessary. 9
Vacuum Transfer
The rate of administration should be adapted to the response of the individual patient, but is generally well-tolerated at a rate of approximately 100 IU per minute.
Factor IX Complex, Konyne® 80 is supplied in single dose bottles with the total IU of factor IX activity stated on the label of each bottle. A suitable volume of Sterile Water for Injection, USP, a sterile double-ended transfer needle, and a sterile filter needle are provided.
| Approximate Factor IX | ||
| NDC Number | Activity | Diluent |
| 0026-0626-20 | 500 IU | 20 mL |
| 0026-0626-50 | 1000 IU | 40 mL |
Konyne (factor ix complex) 80 should be stored under refrigeration (2-8°C; 36-46°F). Freezing should be avoided as breakage of the diluent bottle might occur.
Konyne (factor ix complex) 80 concentrate may be stored for a period of up to 1 month at temperatures not to exceed 25°C (77°F) during travel.
U.S. federal law prohibits dispensing without prescription.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors it is important that this product be stored properly, that the directions be followed carefully during use, and that the risk of transmitting viruses be carefully weighed before the product is prescribed.
No warranty, express or implied, including any warranty of merchantability or fitness is made. Representatives of the Company are not authorized to vary the terms or the contents of the printed labeling, including the package insert, for this product except by printed notice from the Company's headquarters. The prescriber and user of this product must accept the terms hereof.
In some patients the rapid administration of Konyne (factor ix complex) 80 can cause transient fever, chills, headache, flushing or tingling.
Increased toxicity: Do not coadminister with aminocaproic acid may increase risk for thrombosis.
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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. |
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.
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.
Symptoms include disseminated intravascular coagulation (DIC).
Liver disease with signs of intravascular coagulation or fibrinolysis, not for use in factor VII deficiencies, patients undergoing elective surgery.
Factor IX Complex raises the plasma level of factor IX and restores hemostasis in patients with factor IX deficiency. In general, a level of factor IX less than 5% of normal will give rise to spontaneous hemorrhage, while levels greater than 20% of normal will lead to satisfactory hemostasis even in the face of trauma or surgery. Approximately 30% to 50% of the factor IX activity can be detected in a hemophilia B (factor IX deficiency) recipient's plasma immediately after infusion. 1,2 The biological activity of the infused factor IX disappears from the plasma with a half-life of approximately 24 hours. 2 A pharmacokinetic study in six patients found similar recoveries and half-lives for Konyne (factor ix complex) ® 80 as for Konyne®-HT. It must be noted that administration of Factor IX Complex causes an increase in blood levels of factors II, VII, IX and X.
Factors II, VII, IX and X are the vitamin K dependent coagulation factors and are synthesized in the liver. Congenital deficiencies of each of the four factors do occur and may result in a bleeding tendency. Naturally low levels of the vitamin K dependent factors may also be found in vitamin K deficiency and in severe liver disease.
This product has been heated at 80°C for 72 hours and there is no evidence of adverse effects upon the product. In a study 3 designed to assess the effectiveness of heat treatment at 68°C for 72 hours, hepatitis naive chimpanzees were inoculated with heated Antihemophilic Factor (Human) and Factor IX Complex preparations to which had been previously added non-A, non-B hepatitis Hutchinson Strain 4 to a total level of 2500 chimpanzee infectious doses (CID). The chimpanzees receiving heated preparations failed to exhibit any symptoms of non-A, non-B hepatitis. In contrast, one chimpanzee receiving Antihemophilic Factor (Human) concentrate which was not heated after the non-A, non-B inoculum was added, developed abnormally elevated alanine aminotransferase (ALT) levels beginning 10 weeks postinoculation and liver histopathology at 6 weeks. From these results, it was concluded that the heat treatment employed inactivated a known quantity of non-A, non-B hepatitis: at least 2500 CID.
Additional in vitro studies 5 on the effect of heating Factor IX Complex, Konyne (factor ix complex) ® 80, in a dried state at 80°C for 72 hours, on virus inactivation were carried out with a number of viruses, including human immunodeficiency virus (HIV), added to Factor IX Complex prior to heating. The following table shows the amount of each model virus inactivated by the process:
| Virus | Starting Amount Logs * | Logs Inactivated |
| Vesicular Stomatitis Virus | 8.0 | ≥7.5 |
| Vaccinia Virus | 5.75 | 1.0 |
| Sindbis Virus | 7.25 | ≥6.75 |
| Bovine Parvovirus | 4.5 | 3.5 |
| Human Immunodeficiency Virus (HIV), HIV-1 | 4.8 | ≥4.3 |
| * log 10 TCID 50 /mL (for HIV-1, log 10 TCID 50 ) | ||
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.
