Factor IX

Factor IX used to treat bleeding problems in patients with hemophilia type B.

Factor IX is primarily indicated in conditions like Blood disorders, Hemophilia.

Factor IX is contraindicated in conditions like Hypersensitivity to any component of product.

The severe or irreversible adverse effects of Factor IX, which give rise to further complications include Urticaria, Hepatitis, HIV virus transmission. Factor IX produces potentially life-threatening effects which include Myocardial infarction, Pulmonary embolism, Disseminated intravascular coagulation, deep vein thrombosis. which are responsible for the discontinuation of Factor IX therapy. The signs and symptoms that are produced after the acute overdosage of Factor IX include Hemorrhage, Venous thromboembolism, Myocardial infarction. The symptomatic adverse reactions produced by Factor IX are more or less tolerable and if they become severe, they can be treated symptomatically, these include Headache, Fever, Chills, Flushing, Nausea and vomiting, Unpleasant taste.

Possibility exists for transmission of human viruses (e.g., HIV, hepatitis A virus [HAV], hepatitis B virus [HBV], hepatitis C virus [HCV]) and other infectious agents (e.g., unknown viruses; causative agents for Creutzfeldt-Jakob disease [CJD] or variant CJD [vCJD]). Improved donor screening and viral-inactivating/eliminating procedures (e.g., solvent/detergent, heat-treatment, chromatography, nanofiltration) have reduced but not completely eliminated risk of pathogen transmission with plasma-derived factor IX and factor IX complex preparations. Although transmission of nonenveloped viruses, including HAV and parvovirus B19, has been documented following administration of plasma-derived coagulation factors, risk has been reduced with additional viral attenuation methods such as nanofiltration. Nevertheless, monitor for signs and symptoms of parvovirus B19 and hepatitis A infection during therapy. (See Advice to Patients.) Carefully weigh risk of pathogen transmission versus benefits of therapy. Report any infections thought to be associated with factor IX (human) or factor IX complex (human) to the manufacturer, FDA, and CDC. Risk of hepatitis A or hepatitis B infection. Monitor closely for signs and symptoms of hepatitis A during therapy. (See Advice to Patients.) Hepatitis B vaccine is recommended in all individuals with a bleeding disorder at birth or at time of diagnosis. Immunization with hepatitis A vaccine is recommended for all individuals ≥1 year of age with hemophilia or other congenital bleeding disorders. Individuals receiving blood or plasma infusions may develop signs and symptoms of other viral infections, particularly non-A or non-B hepatitis. Potential vehicle for transmission of HIV. HIV seroconversion reported previously in patients who received factor IX complex (human) from donors not screened for HIV and/or prepared using suboptimal viral-inactivating procedures (e.g., heat-treatment only). No reports to date of HIV transmission with currently available plasma-derived clotting factor preparations. Theoretic possibility of transmitting causative agent of CJD or vCJD. Several probable cases of vCJD transmission reported from transfusion of human RBCs. However, no reports to date of CJD or vCJD transmission from commercially available factor IX products. For further information on CJD and vCJD precautions related to blood and blood products, consult the FDA’s guidance for industry (). Evidence of West Nile virus (WNV) transmission through transplanted organs (e.g., heart, liver, kidney) and blood products. However, WNV transmission through commercially available factor IX preparations unlikely due to current viral-inactivating procedures. For further information on WNV precautions related to blood and blood products, consult the FDA’s guidance for industry (). Serious and potentially fatal thromboembolic events (e.g., MI, venous thrombosis, PE, disseminated intravascular coagulation [DIC]) reported with use of factor IX (human) and factor IX complex (human) preparations. Increased risk in patients with preexisting thrombotic risk factors (e.g., liver disease, concomitant use of thrombogenic drugs, history of thrombosis, DIC) and in those receiving prolonged therapy and/or high dosages of factor IX complex concentrates; also increased risk during postoperative period in patients undergoing surgery, and in neonates. Exercise caution when factor IX (human) or factor IX complex (human) is used in such patients. Weigh potential benefits of the drug against risks of thrombotic complications. Consider using pure (i.e., single-factor) factor IX preparations that may be less thrombogenic than factor IX complex in high-risk patients. Patients undergoing surgery and those with other predisposing risk factors should be monitored closely for manifestations of thromboembolism (e.g., changes in BP or pulse rate, respiratory distress, chest pain, cough) and DIC. Follow recommended dosage guidelines to decrease risk of thromboembolic complications. If evidence of thrombosis or DIC occurs during therapy, discontinue drug immediately and administer appropriate treatment. Nephrotic syndrome reported following immune tolerance induction with factor IX-containing products in patients with hemophilia B who have inhibitors and/or a history of hypersensitivity reactions to factor IX. Safety and efficacy of factor IX products for immune tolerance induction not established. Hypersensitivity reactions (hives, pruritus, edema, chest tightness, angioedema, dyspnea, wheezing, faintness, hypotension, tachycardia, generalized urticaria, shock) reported with use of all factor IX products. Increased risk in patients with certain genetic mutations of factor IX and those with inhibitors to factor IX. (See Development of Inhibitors to Factor IX under Cautions.) Up to 50% of patients with inhibitors to factor IX may experience severe hypersensitivity reactions, including anaphylaxis. Closely observe for hypersensitivity reactions, especially during the initial phases of therapy. If manifestations of hypersensitivity reactions or anaphylaxis occur, discontinue drug immediately and initiate appropriate therapy. Mononine contains trace amounts of murine protein, which may stimulate antibody production and cause hypersensitivity reactions. (See Contraindications under Cautions.) Risk for development of neutralizing antibodies (inhibitors) to factor IX following treatment with factor IX preparations. Reported in about 1–5% of patients with hemophilia B, usually within the first 10–20 days of treatment. Patients with certain genetic mutations of the factor IX gene may be at higher risk of inhibitor development and of experiencing a hypersensitivity reaction. (See Hypersensitivity Reactions under Cautions.) Because of an association between inhibitor development and allergic reactions, evaluate for presence of inhibitors in any patient experiencing hypersensitivity. Monitor patients regularly for development of inhibitors. (See Laboratory Monitoring under Cautions.) Suspect presence of inhibitors if expected factor IX levels not achieved or bleeding not controlled with recommended dose, particularly in those who previously achieved a response. Consultation with a hemophilia treatment center strongly recommended for patients with inhibitors. Monitor factor IX levels at regular intervals to guide dosing and ensure adequate therapeutic response. Monitor for development of inhibitors during treatment and prior to surgery. (See Development of Inhibitors to Factor IX under Cautions.) Category C. Not known whether factor IX (human) or factor IX complex (human) is distributed into human milk. Use with caution in neonates because of potential increased risk of thromboembolic complications. (See Thromboembolic Events under Cautions.) AlphaNine SD: Safety and efficacy not established in patients 16 years of age. In a few studies that included pediatric patients, adverse effects in children were similar to those observed in patients >16 years of age. Bebulin : Safety and efficacy not established. Mononine : Safety and efficacy established in pediatric patients between the ages of 1 day and 20 years; excellent hemostasis achieved with no thrombotic complications. Dosing in children generally based on the same guidelines as for adults. Profilnine : Safety and efficacy not established in patients ≤16 years of age. In a clinical study in patients who previously received factor IX concentrates for hemophilia B, the 2 pediatric patients who received factor IX complex (human) responded similarly to adults and no adverse effects were reported. Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. Select dosage with caution.

Possibility exists for transmission of human viruses (e.g., HIV, hepatitis A virus [HAV], hepatitis B virus [HBV], hepatitis C virus [HCV]) and other infectious agents (e.g., unknown viruses; causative agents for Creutzfeldt-Jakob disease [CJD] or variant CJD [vCJD]). Improved donor screening and viral-inactivating/eliminating procedures (e.g., solvent/detergent, heat-treatment, chromatography, nanofiltration) have reduced but not completely eliminated risk of pathogen transmission with plasma-derived factor IX and factor IX complex preparations. Although transmission of nonenveloped viruses, including HAV and parvovirus B19, has been documented following administration of plasma-derived coagulation factors, risk has been reduced with additional viral attenuation methods such as nanofiltration. Nevertheless, monitor for signs and symptoms of parvovirus B19 and hepatitis A infection during therapy. (See Advice to Patients.) Carefully weigh risk of pathogen transmission versus benefits of therapy. Report any infections thought to be associated with factor IX (human) or factor IX complex (human) to the manufacturer, FDA, and CDC. Risk of hepatitis A or hepatitis B infection. Monitor closely for signs and symptoms of hepatitis A during therapy. (See Advice to Patients.) Hepatitis B vaccine is recommended in all individuals with a bleeding disorder at birth or at time of diagnosis. Immunization with hepatitis A vaccine is recommended for all individuals ≥1 year of age with hemophilia or other congenital bleeding disorders. Individuals receiving blood or plasma infusions may develop signs and symptoms of other viral infections, particularly non-A or non-B hepatitis. Potential vehicle for transmission of HIV. HIV seroconversion reported previously in patients who received factor IX complex (human) from donors not screened for HIV and/or prepared using suboptimal viral-inactivating procedures (e.g., heat-treatment only). No reports to date of HIV transmission with currently available plasma-derived clotting factor preparations. Theoretic possibility of transmitting causative agent of CJD or vCJD. Several probable cases of vCJD transmission reported from transfusion of human RBCs. However, no reports to date of CJD or vCJD transmission from commercially available factor IX products. For further information on CJD and vCJD precautions related to blood and blood products, consult the FDA’s guidance for industry (). Evidence of West Nile virus (WNV) transmission through transplanted organs (e.g., heart, liver, kidney) and blood products. However, WNV transmission through commercially available factor IX preparations unlikely due to current viral-inactivating procedures. For further information on WNV precautions related to blood and blood products, consult the FDA’s guidance for industry (). Serious and potentially fatal thromboembolic events (e.g., MI, venous thrombosis, PE, disseminated intravascular coagulation [DIC]) reported with use of factor IX (human) and factor IX complex (human) preparations. Increased risk in patients with preexisting thrombotic risk factors (e.g., liver disease, concomitant use of thrombogenic drugs, history of thrombosis, DIC) and in those receiving prolonged therapy and/or high dosages of factor IX complex concentrates; also increased risk during postoperative period in patients undergoing surgery, and in neonates. Exercise caution when factor IX (human) or factor IX complex (human) is used in such patients. Weigh potential benefits of the drug against risks of thrombotic complications. Consider using pure (i.e., single-factor) factor IX preparations that may be less thrombogenic than factor IX complex in high-risk patients. Patients undergoing surgery and those with other predisposing risk factors should be monitored closely for manifestations of thromboembolism (e.g., changes in BP or pulse rate, respiratory distress, chest pain, cough) and DIC. Follow recommended dosage guidelines to decrease risk of thromboembolic complications. If evidence of thrombosis or DIC occurs during therapy, discontinue drug immediately and administer appropriate treatment. Nephrotic syndrome reported following immune tolerance induction with factor IX-containing products in patients with hemophilia B who have inhibitors and/or a history of hypersensitivity reactions to factor IX. Safety and efficacy of factor IX products for immune tolerance induction not established. Hypersensitivity reactions (hives, pruritus, edema, chest tightness, angioedema, dyspnea, wheezing, faintness, hypotension, tachycardia, generalized urticaria, shock) reported with use of all factor IX products. Increased risk in patients with certain genetic mutations of factor IX and those with inhibitors to factor IX. (See Development of Inhibitors to Factor IX under Cautions.) Up to 50% of patients with inhibitors to factor IX may experience severe hypersensitivity reactions, including anaphylaxis. Closely observe for hypersensitivity reactions, especially during the initial phases of therapy. If manifestations of hypersensitivity reactions or anaphylaxis occur, discontinue drug immediately and initiate appropriate therapy. Mononine contains trace amounts of murine protein, which may stimulate antibody production and cause hypersensitivity reactions. (See Contraindications under Cautions.) Risk for development of neutralizing antibodies (inhibitors) to factor IX following treatment with factor IX preparations. Reported in about 1–5% of patients with hemophilia B, usually within the first 10–20 days of treatment. Patients with certain genetic mutations of the factor IX gene may be at higher risk of inhibitor development and of experiencing a hypersensitivity reaction. (See Hypersensitivity Reactions under Cautions.) Because of an association between inhibitor development and allergic reactions, evaluate for presence of inhibitors in any patient experiencing hypersensitivity. Monitor patients regularly for development of inhibitors. (See Laboratory Monitoring under Cautions.) Suspect presence of inhibitors if expected factor IX levels not achieved or bleeding not controlled with recommended dose, particularly in those who previously achieved a response. Consultation with a hemophilia treatment center strongly recommended for patients with inhibitors. Monitor factor IX levels at regular intervals to guide dosing and ensure adequate therapeutic response. Monitor for development of inhibitors during treatment and prior to surgery. (See Development of Inhibitors to Factor IX under Cautions.) Category C. Not known whether factor IX (human) or factor IX complex (human) is distributed into human milk. Use with caution in neonates because of potential increased risk of thromboembolic complications. (See Thromboembolic Events under Cautions.) AlphaNine SD: Safety and efficacy not established in patients 16 years of age. In a few studies that included pediatric patients, adverse effects in children were similar to those observed in patients >16 years of age. Bebulin : Safety and efficacy not established. Mononine : Safety and efficacy established in pediatric patients between the ages of 1 day and 20 years; excellent hemostasis achieved with no thrombotic complications. Dosing in children generally based on the same guidelines as for adults. Profilnine : Safety and efficacy not established in patients ≤16 years of age. In a clinical study in patients who previously received factor IX concentrates for hemophilia B, the 2 pediatric patients who received factor IX complex (human) responded similarly to adults and no adverse effects were reported. Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. Select dosage with caution.

225 units/min (220 (225)) As recommended. IV — Infuse at a rate not exceeding 2 mL/minute.(225 units/min~2mL/min

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

No data regarding the interactions of Factor IX was found.

Dry Powder Store at room temperature or refrigerator. Use within 1-6 month if kept at room temperature. Inj (reconstituted soln) Store at room temperature. Use within 3 hrs if kept at room temperature.