factor IX

Action and Spectrum

Actions and spectrum: 

factor IX is a clotting factor that plays a crucial role in the coagulation cascade. It works by activating other clotting factors in the blood, leading to the formation of a clot to stop bleeding.

factor IX deficiency or dysfunction can lead to hemophilia B, a bleeding disorder characterized by abnormal bleeding, especially into the joints and muscles.

Treatment with factor IX can help prevent and control bleeding episodes in people with hemophilia B. It can also be used for prophylaxis to prevent bleeding in those with severe hemophilia B. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Rash (1.6-7.7%) 

Nausea (6.2%) 

Rhinitis (4.6%) 

Dyspnea (3.2%) 

Flushing (3.1%) 

Dizziness (7.7%) 

pain in injection site (6.2%) 

Urticaria (3.1-4.8%) 

taste sense altered (4.6%) 

Fever (3.1%) 

Allergic reaction (1.5%)
 

Frequency not defined 

Altered bp 

Myocardial infarction 

Chills 

Vomiting 

Stinging at the infusion site 

Anaphylaxis 

Lethargy 

Thrombosis 

DIC 

Tingling 

viral infection: Human-derived products 

Hives 

Black Box Warning

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

factor IX is contraindicated in individuals who have experienced a severe allergic reaction to the medication or its components. It should also be avoided in individuals with disseminated intravascular coagulation (DIC) and a known hypersensitivity to hamster proteins. Additionally, factor IX should not be used in individuals with a history of thrombosis, as it may increase the risk of blood clots

Caution: 

• Hypersensitivity: Patients may develop hypersensitivity reactions, including anaphylaxis. 
• Inhibitor formation: Some patients who are treated with factor IX may develop inhibitors to the protein, which can reduce or negate its effectiveness. 
• Thrombosis: Administration of factor IX may lead to the development of thrombotic events, especially in patients with a history of cardiovascular disease, liver disease, or disseminated intravascular coagulation. 
• Transmission of infectious agents: As with any biological product, there is a risk of transmission of infectious agents, such as viruses, despite steps taken during manufacturing to minimize this risk. 
• Hepatitis B surface antigen: Patients receiving factor IX may develop antibodies to hepatitis B surface antigen. Therefore, it is important to test patients for hepatitis B surface antigen and antibodies before initiating therapy with factor IX. 
• Renal impairment: In patients with renal impairment, factor IX may accumulate and prolong its half-life, increasing the risk of thrombotic events

Comorbidities: 

factor IX is a medication used for the treatment and prevention of bleeding episodes in patients with hemophilia B, which is caused by a deficiency in clotting factor IX. Patients with hemophilia B may have an increased risk of developing inhibitors to factor IX, which can make the medication less effective.

Additionally, patients with liver disease may have impaired factor IX synthesis and may require careful monitoring when receiving treatment. Patients with known hypersensitivity to factor IX or any of its components should also use caution when receiving this medication. It is important to discuss any potential comorbidities with a healthcare provider before starting treatment with factor IX. 

Pregnancy / Lactation

Pregnancy consideration: US FDA pregnancy category: Not assigned 

Lactation: It is not known whether factor IX can be excreted in human

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester. 
• Category B: There is no evidence of risk to the fetus found in animal reproduction studies and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women. 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh risks over benefits These category drugs should be prohibited for pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

factor IX is a vitamin K-dependent clotting factor that plays a key role in the intrinsic pathway of the coagulation cascade. It is gets synthesized in the liver and then circulates in the blood as an inactive precursor, prothrombin. Upon activation, it cleaves prothrombin to form thrombin, which gets converted from fibrinogen to fibrin and forms a clot. 

The pharmacology of factor IX replacement therapy involves the administration of exogenous factor IX to replace the deficient or dysfunctional endogenous factor IX. This is typically accomplished using factor IX concentrates, which can be derived from human plasma or produced using recombinant DNA technology. The concentrates are purified to remove other clotting factors and potential contaminants, and they may also be treated to inactivate viruses and other pathogens

Pharmacodynamics: 

factor IX forms a complex with factor VIII and activates factor X, which leads to the formation of fibrin and the clotting of blood. 

The activity of factor IX is measured in international units (IU), which represents the amount of factor IX required to achieve 50% of normal clotting activity in plasma. The half-life of factor IX is 18-24 hours. 

In patients with hemophilia B, the administration of factor IX increases the level of active factor IX in the blood, leading to the formation of a stable clot and cessation of bleeding. The degree and duration of response to factor IX therapy depend on the severity of the patient’s hemophilia, the amount of factor IX administered, and the location and severity of the bleeding episode

Pharmacokinetics: 

Absorption 

factor IX is administered intravenously, and therefore, absorption is not applicable. 

Distribution 

The distribution of factor IX is rapid and occurs throughout the circulatory system, with elevated levels of factor IX found in the liver. 

Metabolism 

factor IX is metabolized by the liver through proteolysis and is subsequently excreted in the urine. 

Elimination and excretion 

The half-life of factor IX is approximately 24 hours. It is eliminated from the body primarily through the kidneys. 

Adminstartion

Administration: 

factor IX is administered intravenously, usually into a vein in the arm. The dose and frequency of administration depend on the patient’s individual needs, including their weight, severity of bleeding, and location of bleeding. The dose may also be adjusted based on the patient’s response to treatment and their individual pharmacokinetic profile.

It is important for healthcare providers to closely monitor patients receiving factor IX and adjust the dose as necessary to ensure optimal therapeutic benefit while minimizing the risk of adverse effects. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: factor

Why do we use factor IX? 

factor IX is primarily used in the treatment and prevention of bleeding episodes in patients with hemophilia B, also known as Christmas disease. Hemophilia B is a genetic bleeding disorder caused by a deficiency in factor IX, a protein involved in the blood clotting process.

Patients with hemophilia B may experience spontaneous bleeding episodes or bleeding after injury or surgery and may require factor IX replacement therapy to prevent or control bleeding. factor IX is also used for prophylaxis, or the prevention of bleeding episodes in patients with hemophilia B.