factor X, human

Action and Spectrum

Actions and Spectrum: 

factor X, also known as the Stuart-Prower factor, is a crucial component of the coagulation cascade, which is responsible for forming blood clots to prevent excessive bleeding. A vitamin K-dependent serine protease converts prothrombin into thrombin, which converts fibrinogen to fibrin, the primary component of blood clots.  

The activation of factor X occurs through two extrinsic and intrinsic pathways. The extrinsic pathway is initiated by the tissue factor released from damaged tissues. In contrast, blood exposure to negatively charged surfaces, such as collagen, activates the intrinsic pathway.  

The spectrum of activity of factor X is mainly limited to the coagulation cascade. However, it is also involved in other biological processes, such as regulating fibrinolysis, angiogenesis, and inflammation. Additionally, factor X has been shown to have antimicrobial activity against bacteria, viruses, and fungi, suggesting a potential role in the immune response. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Fatigue (5.6%) 

Infusion site pain (5.6%) 

Infusion site erythema (5.6%) 

Back pain (5.6%) 

Black Box Warning

Contraindication / Caution

Contraindications/caution: 

Contraindications: 

• factor X, as a medication, is used to treat bleeding disorders, such as Hemophilia B and other factor X deficiencies. It is usually administered by injection, and like all medications, it may have specific contraindications. 

• The use of factor X, human, is contraindicated in individuals who have a known hypersensitivity to the medication or any of its components. It is also contraindicated in disseminated intravascular coagulation (DIC) patients, characterized by abnormal clotting and bleeding due to an underlying medical condition. 

• Other conditions that may require caution when using factor X human include liver disease, as the liver produces clotting factors, including factor X, and a severe deficiency of protein C or S, which may increase the risk of thrombosis. 

Caution: 

• Risk of Thrombosis: factor X, human, can increase the risk of thrombosis (the formation of a blood clot within a blood vessel), particularly in patients with liver disease, a severe deficiency of protein C or S, or a history of thrombotic events. Therefore, it should be used cautiously in patients with a history of thrombotic events or other risk factors for thrombosis. 

• Viral Infections: factor X, human, is derived from human blood plasma, and there is a risk of transmission of viral infections, such as HIV and hepatitis, despite rigorous screening and purification procedures. Patients receiving factor X, human, should be monitored for signs of viral infection. 

• Allergic Reactions: Like all medications, factor X, human, may cause allergic reactions in some individuals. Patients should be monitored for signs of an allergic reaction, such as rash, hives, itching, swelling, or difficulty breathing. 

• Administration: factor X, human, is administered by injection and should be given by a healthcare professional trained in clotting factor concentrates. 

• Interactions with other medications: factor X, human, may interact with other medications, including anticoagulants, antiplatelet agents, and some antibiotics.

Pregnancy / Lactation

Pregnancy consideration: Insufficient data available 

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: 

Human factor X is a purified blood clotting factor used to treat bleeding disorders, such as Hemophilia B and other factor X deficiencies. It is an inactive proenzyme converted to its active form by cleavage of a peptide bond by factor IXa or factor VIIa, depending on the activation pathway. 

Once activated, factor Xa functions as a serine protease, catalyzing prothrombin conversion to thrombin, a critical step in the blood clotting cascade. Thrombin, in turn, cleaves fibrinogen to form fibrin, which forms the basis of a blood clot. factor Xa also plays a role in regulating fibrinolysis, angiogenesis, and inflammation. 

Pharmacodynamics: 

factor X, human, is effective in treating bleeding episodes associated with factor X deficiency, including surgical bleeding and spontaneous bleeding. The dose of factor X, human, required to achieve hemostasis may vary depending on the severity of the bleeding episode, the patient’s weight, and the presence of inhibitors to factor X. 

Pharmacokinetics: 

Absorption 

factor X, human is administered intravenously, meaning it is directly introduced into the bloodstream. Therefore, it is rapidly absorbed and reaches its target site quickly. 

Distribution 

factor X, human, is distributed throughout the body via the bloodstream. It binds to plasma proteins and is distributed in a volume of approximately 1.5 L/kg. The distribution of factor X humans may be affected by patient age, weight, liver function, and the presence of inhibitors to factor X. 

Metabolism 

factor X is a human protein metabolized by proteolytic cleavage by enzymes such as factor IXa or factor VIIa to its active form, factor Xa. factor Xa, in turn, is involved in converting prothrombin to thrombin. 

Elimination and Excretion 

factor X, human, is excreted from the body primarily through the urine, although small amounts may also be excreted in the feces. 

Adminstartion

Administration: 

• Dosage: The dosage of factor X, human, depends on several factors, including the patient’s weight, the severity of the bleeding disorder, and the presence of inhibitors to factor X. The dose may need to be adjusted based on the patient’s response to treatment. 
• Route of Administration: factor X, human, is administered by IV infusions. The medication is typically supplied as a lyophilized powder reconstituted with sterile water or saline before administration. The reconstituted solution should be inspected visually for particulate matter and discoloration before administration. 
• Infusion Rate: The infusion rate of factor X, human, should be adjusted based on the patient’s tolerance and the severity of the bleeding episode. Infusion rates that are too fast may cause adverse reactions such as flushing, headache, and hypotension. Infusion rates that are too slow may not achieve the desired therapeutic effect. 
• Monitoring: Patients receiving factor X, human, should be closely monitored for signs of adverse reactions, such as allergic reactions, thrombotic events, and coagulation abnormalities. Laboratory monitoring of coagulation parameters may also be required to ensure the desired therapeutic effect is achieved. 
• Storage: factor X, human, should be stored in a refrigerator at a temperature of 2-8°C. The medication should not be frozen or exposed to direct sunlight. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: factor X, human  

Why do we use factor X, human? 

factor X, human, is a medication used to treat bleeding disorders caused by a deficiency or dysfunction of factor X in the blood. Here are some specific uses of factor X, human: 

• Hereditary factor X Deficiency: factor X, human, is used to treat hereditary factor X deficiency, a rare genetic bleeding disorder in which the blood is deficient in factor X. This disorder is associated with prolonged bleeding, particularly after surgery or trauma. 
• Acquired Factor X Deficiency: factor X, human, may also be used to treat acquired factor X deficiency, which can be caused by liver disease, vitamin K deficiency, or certain medications such as warfarin. Acquired factor X deficiency can also result in prolonged bleeding. 
• Reversal of Anticoagulant Therapy: In some cases, factor X, human, may be used to reverse the anticoagulant effects of certain medications, such as rivaroxaban or apixaban, which inhibit factor Xa. This may be necessary when urgent surgery or invasive procedures are required. 
• Treatment of Hemorrhagic Complications: factor X, human, may also be used to treat hemorrhagic complications associated with other bleeding disorders such as hemophilia, von Willebrand disease, or severe liver disease.