factor IX, recombinant/albumin fusion protein

Action and Spectrum

Actions and Spectrum:  

The action of factor IX, recombinant/albumin fusion protein is to replace the missing or deficient factor IX in the patient’s blood. Once administered, it binds to factor VIII and other clotting factors to form a complex that activates the coagulation cascade and promotes the formation of a stable blood clot to stop bleeding. 

The spectrum of activity of factor IX recombinant/albumin fusion protein is specific to hemophilia B, as it only addresses the deficiency of factor IX in those individuals. It is not effective in treating other bleeding disorders or medical conditions that cause abnormal bleeding. The medication has a prolonged half-life, allowing for less frequent dosing and greater patient convenience. 

Drug Interaction

Adverse Reaction

Frequency defined  

<1% 

Rash 

Hypersensitivity 

Dizziness 

Eczema  

1-10% 

Headache (1.8%) 

Black Box Warning

Black Box Warning:  

Patients with a history of cardiovascular disease, liver disease, or those who are undergoing surgery or immobilization may have an increased risk of thromboembolic events (blood clots) when using factor IX, recombinant/albumin fusion protein. 

Contraindication / Caution

Contraindication/Caution:  

Hypersensitivity: Patients who have experienced a severe allergic reaction to any of the components of factor IX, recombinant/albumin fusion protein should not receive this medication. 

Disseminated Intravascular Coagulation (DIC): Patients with DIC, a severe condition characterized by abnormal blood clotting and bleeding, should not receive factor IX, recombinant/albumin fusion protein as it can worsen their condition. 

Liver disease: Patients with liver disease may have impaired metabolism of factor IX, recombinant/albumin fusion protein, which can increase the risk of bleeding or other adverse effects. 

Cardiovascular disease: Patients with a history of cardiovascular disease may be at increased risk of developing blood clots when treated with factor IX, recombinant/albumin fusion protein. 

Pregnancy and breastfeeding: The safety of factor IX, recombinant/albumin fusion protein during pregnancy and breastfeeding has not been established. Therefore, it should only be used if the potential benefits outweigh the potential risks. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excreted into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

<b>Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

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 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:

factor IX recombinant/albumin fusion protein (rIX-FP) is a medication that is commonly used to prevent and treat bleeding in patients who suffer from hemophilia B, a bleeding disorder characterized by a deficiency of clotting factor IX. The unique aspect of rIX-FP is that it is a fusion protein that combines the clotting activity of factor IX with the stability of albumin. This innovative medication provides patients with the necessary clotting factor while also extending the half-life of the protein in their bloodstream. 

Pharmacodynamics: 

factor IX, recombinant/albumin fusion protein (Rx) works by binding to factor VIII, which leads to the activation of factor X and subsequent formation of the prothrombinase complex. This complex converts prothrombin to thrombin, which in turn converts fibrinogen to fibrin and stabilizes the blood clot. 

MOA:  

fusion protein works by replacing the missing or deficient factor IX in patients with hemophilia B. factor IX plays a crucial role in the process of blood clotting. When a blood vessel is damaged, factor IX becomes activated and binds with other clotting factors to initiate a series of reactions that lead to the formation of a blood clot, ultimately stopping bleeding.In patients with hemophilia B, the lack of factor IX leads to prolonged bleeding and an increased risk of bleeding episodes. 

Pharmacokinetics: 

Absorption:  

factor IX , recombinant/albumin fusion protein, is administered via intravenous injection. This indicates that medication is administered directly into the bloodstream, bypassing the gastrointestinal tract, which results in fast absorption. 

Distribution:  

factor IX, recombinant/albumin fusion protein, is distributed throughout the body via the bloodstream. The medication exhibits high protein binding, indicating that it attaches to proteins in the bloodstream and is less susceptible to filtration by the kidneys, leading to a longer half-life in the body. 

Metabolism: 

 factor IX, recombinant/albumin fusion protein, is metabolized in the liver. The medication is broken down into smaller molecules, then eliminated from the body. 

Excretion and elimination:  

The metabolites of factor IX , recombinant/albumin fusion protein, are excreted primarily in the urine. The medication has a relatively short half-life of about 20 hours, which means that it is eliminated from the body relatively quickly. 

Adminstartion

Administration:  

Preparation: The healthcare provider will review the patient’s medical history and check their clotting factor levels. They will then prepare the factor IX recombinant/albumin fusion protein according to the manufacturer’s instructions. 

Administration: The administration of this medication involves an intravenous injection into a vein. A healthcare professional will insert a needle into the patient’s vein and gradually inject the medication over a few minutes. The appropriate dosage and frequency of administration will be determined based on the patient’s condition and the extent of their hemophilia B. 

Monitoring: After administration, the patient will be monitored for any adverse reactions, such as allergies or bleeding. The healthcare provider will also monitor the patient’s clotting factor levels to ensure that they are within the appropriate range. 

Follow-up: The healthcare provider will schedule follow-up appointments to monitor the patient’s condition and adjust the dosage of factor IX recombinant/albumin fusion protein as needed. The patient should also be advised to immediately report any unusual bleeding or symptoms to their healthcare provider. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: factor IX, recombinant/albumin fusion protein 

Why do we use factor IX, recombinant/albumin fusion protein?  

factor IX, recombinant/albumin fusion protein is a genetically engineered protein that combines factor IX with albumin, a protein found in blood. This fusion protein has several advantages over other factor IX replacement therapies: 

Longer half-life: The albumin fusion prolongs the half-life of factor IX, meaning that the protein stays in the bloodstream for longer, reducing the frequency of needed injections. 

Reduced risk of immune reactions: Because the fusion protein includes albumin, which is a naturally occurring protein in the body, it is less likely to trigger an immune response compared to other factor IX replacement therapies. 

Efficacy: Clinical studies have shown that factor IX, recombinant/albumin fusion protein is effective in controlling bleeding episodes and preventing the recurrence of bleeding in patients with hemophilia B.