factor IX complex

Action and Spectrum

Actions and Spectrum: 

The factor IX complex works by replenishing the levels of clotting factors in people with deficiencies, thereby promoting the formation of blood clots and reducing the risk of bleeding. factor IX, one of the key components of the complex, is a clotting factor that plays a critical role in the coagulation cascade. When activated, factor IX cleaves factor X to generate activated factor X (factor Xa), which, in turn, activates prothrombin (factor II) to generate thrombin. Thrombin then converts fibrinogen to fibrin, which forms a stable clot. 

The factor IX complex is primarily used to treat bleeding disorders caused by deficiencies in clotting factors. One of them is Haemophilia B (also known as Christmas disease), a rare genetic bleeding disorder that affects approximately 1 in 30,000 males. A factor IX deficiency in haemophilia B leads to excessive bleeding and inadequate wound healing. The factor IX complex can also be used to treat bleeding disorders caused by other clotting factor deficiencies, such as those caused by liver disease or vitamin K deficiency. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Formation of anti-factor IX antibodies in the circulation 

Post-marketing reports 

Headache 

Thromboembolic events 

Abdominal pain 

Angioedema 

Nephrotic syndrome 

Infusion site reactions 

Anaphylactic reactions 

Black Box Warning

Contraindication / Caution

Contraindications/caution: 

Contraindications: 

• Any component of the factor IX complex, including factor IX, factor II (prothrombin), factor VII, and factor X, is known to cause hypersensitivity. 
• Known history of thromboembolic events, such as deep vein thrombosis (DVT), pulmonary embolism (PE), or stroke. 

Caution: 

• Thromboembolic events: The factor IX complex can increase the risk of thromboembolic events (such as ,pulmonary embolism,deep vein thrombosis or stroke) in patients with a history of these conditions or other risk factors (such as immobility, obesity, or smoking). The medication should be used cautiously in these patients and monitored closely for any signs of blood clots. 
• Hypersensitivity reactions: Some patients may experience hypersensitivity reactions, such as rash, hives, or difficulty breathing when receiving the factor IX complex.  The medication should be discontinued immediately if an allergic reaction occurs. 
• Volume overload: The factor IX complex is administered intravenously and may cause volume overload in patients with heart failure or other cardiac conditions. The medication should be used cautiously in these patients, and fluid balance should be closely monitored. 
• Hepatic and renal impairment: The factor IX complex is eliminated in the urine after being metabolised in the liver. The medication should be used cautiously in these patients, and the dosage may need to be adjusted. 

Pregnancy / Lactation

Pregnancy consideration: C 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.   

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

• The factor IX complex is a medication composed of four clotting factors: factor IX (also known as Christmas factor), factor II (prothrombin), factor VII, and factor X. These clotting factors work together in a complex cascade to form clots and stop bleeding. 

• factor IX is a glycoprotein produced in the liver that plays a crucial role in the intrinsic pathway of the coagulation cascade. It is converted to its active form, factor IXa, in the presence of factor VIIIa and calcium ions. factor IXa then activates factor X, leading to the formation of thrombin and fibrin clots. 

• factor II (prothrombin) is a precursor to thrombin, which converts fibrinogen to fibrin, the main component of blood clots. 

• factor VII is a vitamin K-dependent protein that activates factor X in the extrinsic pathway of the coagulation cascade. 

• factor X is a vitamin K-dependent protein that converts prothrombin to thrombin in the presence of factor Va and calcium ions. 

Pharmacodynamics: 

The pharmacodynamics of the factor IX complex involves the replacement of deficient clotting factors in the coagulation cascade, allowing for proper clot formation and stopping bleeding in patients with bleeding disorders such as hemophilia B. The medication can also affect the coagulation system beyond clot formation, including an increased risk of thromboembolic events and potential adverse effects in patients with heart failure or other cardiac conditions. 

Pharmacokinetics: 

Absorption 

factor IX complex is administered intravenously, meaning it is directly introduced into the bloodstream and immediately available for use. 

Distribution 

The clotting factors in factor IX complex are distributed throughout the body in the bloodstream, allowing for clot formation and stopping bleeding at the injury site. 

Metabolism 

The clotting factors in factor IX complex are metabolized in the liver, where they are broken down into smaller molecules and cleared from the body. 

Elimination and Excretion 

The metabolites of the factor IX complex are excreted in the urine and feces, with most of the medication being cleared from the body within 24-48 hours. 

Adminstartion

Administration: 

• factor IX complex is a medication administered intravenously to treat bleeding in patients with factor IX deficiency, also known as haemophilia B, and other bleeding disorders resulting from a deficiency in clotting factors II, VII, or X.  
• The specific dose, frequency, and duration of treatment with factor IX complex will depend on the patient’s weight, bleeding severity, and response to treatment. The medication is typically administered in a hospital or clinic, where the patient can be monitored for adverse reactions. 

• factor IX complex should be administered slowly over 10-30 minutes to minimize the risk of adverse reactions such as allergic reactions or hypotension. The medication should not be mixed with other medications or solutions and should be administered using a separate IV line.

• Patients receiving factor IX complex may require regular monitoring of clotting factor levels and coagulation tests to determine the appropriate dose and frequency of treatment. In some cases, patients may also receive prophylactic treatment with factor IX complex to prevent bleeding episodes. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: factor IX complex 

Why do we use factor IX complex? 

• factor IX complex is a medication that is primarily used to treat bleeding episodes in patients with factor IX deficiency, also known as hemophilia B, and other bleeding disorders that result from a deficiency in clotting factors II, VII, or X. factor IX complex can help to control bleeding by replenishing the clotting factors that are deficient in these patients. 
• factor IX complex is also sometimes used for prophylactic treatment in patients with hemophilia B who have frequent bleeding episodes or undergoing surgery or other medical procedures that could cause bleeding. Prophylactic treatment involves administering factor IX complex regularly to prevent bleeding episodes from occurring. 
• Additionally, the factor IX complex may be used in some instances of acquired hemophilia, a rare condition in which the body produces antibodies that attack clotting factors in the blood, leading to bleeding episodes. The medication can help to replenish the clotting factors and control bleeding in these patients.