NovoThirteen

NovoThirteen Uses, Dosage, Side Effects, Food Interaction and all others data.

Coagulation Factor XIII A-Subunit (Recombinant), also known as catridecacog, is a recombinant form of the Factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits . 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 available coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 catalytic A-subunits and 2 non-catalytic B-subunits (FXIII-A2B2) . When activated by thrombin at the site of injury, the FXIII A2B2 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 .

When supplied as the recombinant form, Coagulation Factor XIII A-Subunit (Recombinant) binds to free human FXIII B-subunit resulting in a heterotetramer (rA2B2) with a similar activity profile and half-life as the endogenously available form. In patients with congenital factor XIII A-subunit deficiency, this product (marketed as Tretten) is indicated for the routine prophylaxis of bleeding. In these patients, activated rFXIII has been shown to increase the mechanical strength of fibrin clots, slow down fibrinolysis, and to enhance platelet adhesion to the site of injury. As the half-life of endogenous Factor XIII is long (5-11 days), prophylactic therapy with the replacement of FXIII can be given every 4-6 to maintain hemostasis.

NovoThirteen
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Uses during Pregnancy
Uses during Breastfeeding
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Trade Name	NovoThirteen
Generic	Catridecacog
Catridecacog Other Names	Catridecacog, Coagulation Factor XIII A-Subunit (recombinant), Factor XIII A-Subunit (Recombinant), Recombinant Coagulation Factor XIII
Type
Groups	Approved
Therapeutic Class
Manufacturer
Available Country	Netherlands,
Last Updated:	September 19, 2023 at 7:00 am

Uses

NovoThirteen is a recombinant FXIII subunit‐A molecule evaluated for clotting factor replacement therapy in congenital FXIII deficiency.

For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.

NovoThirteen is also used to associated treatment for these conditions: Bleeding

Toxicity

The most common adverse reactions reported in clinical trials (≥1%), were headache, pain in the extremities, injection site pain, and increase in fibrin D dimer levels. Due to the anti-clotting activity of this medication, thromboembolic complications may occur with its usage.