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RX BIN: 015558RX PCN: HTGroup ID: DDN6600Card Holder ID: DDN6600
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2019 Price of Benefix

$346.651 kit (single dose) 250iu
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Coagulation Factor IX (Recombinant) volume of distribution

In studies of the effect of EDTA on circulating factor IX concentrations, 40 μL of 0.5 M EDTA (pH 7.4) was injected into the jugular vein 11 minutes or 12 hours after factor IX injection. The final sample was taken 1 minute later. The volumes of the 2 compartments were calculated using the total steady-state volume of distribution.

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What is Coagulation Factor IX (Recombinant)

Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. ; ; Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).

Coagulation Factor IX (Recombinant) mechanism of action

Coagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX’s activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.

Dosage forms of Coagulation Factor IX (Recombinant)

FormRouteStrength
Powder for solutionintravenous1000 unit
Powder for solutionintravenous2000 unit
Powder for solutionintravenous250 unit

Prescription Generics

false

International Brands

Benefix

Synonyms

Coagulation factor IX (recombinant) Coagulation factor IX recombinant human

Manufacturers

Pfizer Canada Inc

CAS number

181054-95-5

UNII

382L14738L

State

liquid

Affected organisms

Humans and other mammals

Indication of Coagulation Factor IX (Recombinant)

For treatment of hemophilia (Christmas disease).

Toxicity of Coagulation Factor IX (Recombinant)

High-capacity adenoviral vectors (HCAV) with episomic persistence, bearing no viral genes, are known to trigger a reduced immune response, and the use of a tissue-specific promoter (e.g. hepatic) can further diminish the response, therefore prolonging the gene expression period. HCAV with a liver-specific promoter has yielded therapeutic expression levels of IX with limited toxicity in hemophilic mice and hemophilic dogs, and yet a gradual decline in transgene expression was observed. Inhibitor antibodies, as well as hematologic and hepatic toxicities, were detected in animals injected at high vector doses, limiting the expression period to 446-604 days in dogs.

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