Fibrogammin P
Fibrogammin P Uses, Dosage, Side Effects, Food Interaction and all others data.
Fibrogammin P is a heat-treated, lyophilized concentrate of coagulation factor XIII, an endogenous enzyme responsible for the crosslinking of fibrin and an essential component of the coagulation cascade . For people with congenital deficiency or mutation of Factor XIII, a rare bleeding disorder, exogenous replacement of this key coagulation factor is essential for management and prevention of bleeding episodes.
Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously produced coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 A-subunits and 2 B-subunits (A2B2). When activated by thrombin at the site of injury, the FXIII pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis .
Other drug products with similar structure and function to Fibrogammin P include Catridecacog, which is a recombinant form of the A subunit of human coagulation factor XIII. Compared to Fibrogammin P, which is purified from pooled human plasma, Catridecacog is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated .
| Trade Name | Fibrogammin P |
| Generic | Factor XIII (human) |
| Factor XIII (human) Other Names | Coagulation factor XIII, recombinant, Factor XIII, Factor XIII (fibrin stabilising factor), Factor XIII concentrate (human), Factor XIII, human, Fibrinoligase, Human coagulation factor XIII |
| Type | |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Fibrogammin P is a purified form of Factor XIII that is used to prevent and treat surgical bleeding in patients with a Factor XIII deficiency.
Factor XIII (Human), available as the commercially available product Corifact, is approved by the Food and Drug Administration for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency .
Fibrogammin P is also used to associated treatment for these conditions: Perioperative Blood Loss
How Fibrogammin P works
Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously produced coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 A-subunits and 2 B-subunits (A2B2). When activated by thrombin at the site of injury, the FXIII pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis . Exogenous replacement of Factor XIII is a cornerstone of treatment for bleeding associated with congenital Factor XIII deficiency.
Toxicity
Corifact was studied in an acute toxicity study in mice and rats at doses up to 3550 units per kg and 1420 units per kg, respectively. Repeat dose toxicity was studied in rats at daily doses up to 350 units per kg for a period of 14 days. No signs of toxicity were observed in the single dose and repeat dose studies.
A local tolerance study in rabbits demonstrated no clinical or histopathological changes at the injection site after intravenous, intra-arterial or para-venous administration of Corifact.
A thrombogenicity test was performed in rabbits at doses up to 350 units per kg. Corifact showed no thrombogenic potential at the doses tested.
Food Interaction
No interactions found.Volume of Distribution
Vss = 51.1 mL/kg (volume of distribution at steady state)
Elimination Route
Tmax = 1.7 ±1.44 hr Tmax = 1.72 hr
Cmax = 0.9 ±0.20 units/mL (peak concentration at steady state) Cmax = 87.7% (peak concentration at steady state)
Half Life
6.6 ±2.29 days 6.6 days
Clearance
0.25 ±0.09 mL/hr/kg 0.25 mL/hr/kg
Innovators Monograph
You find simplified version here Fibrogammin P
