General Information

Tretten consists of coagulation factor XIII A-subunit (recombinant). Recombinant human Factor XIII (rFXIII) is integral in the formation of blood clots. In the absence of Factor XIII, loosely formed clots are developed, leading to bleeding complications.

Tretten is specifically indicated for the routine prophylaxis of bleeding in people with congenital factor XIII (FXIII) A-subunit deficiency.

Mechanism of Action

Tretten consists of coagulation factor XIII A-subunit (recombinant). Recombinant human factor XIII (rFXIII) is integral in the formation of blood clots. In the absence of factor XIII, loosely formed clots are developed, leading to bleeding complications.

Side Effects

Adverse effects associated with the use of Tretten may include, but are not limited to, the following:

• headache
• pain in the extremities
• injection site pain
• D-dimer increase

Dosing/Administration

Tretten is supplied as a solution for infusion. The recommended dose is monthly 35 IU/kg injections.

Clinical Trial Results

The FDA approval of Tretten was based on a phase 3 trial in 41 subjects. Data showed that when compared to an historic control group of subjects who did not receive routine FXIII infusions, preventive treatment with monthly 35 IU/kg Tretten injections significantly decreased the number of treatment-requiring bleeding episodes. During the prophylaxis treatment period with Tretten (434 subject months), five bleeding episodes treated with FXIII-containing products were observed in four subjects. All five were associated with trauma. When calculated for all 41 subjects, this translated into a mean annual rate of bleeding episodes that required treatment of 0.14 per subject year, which was statistically significantly lower than the historic bleeding rate of 1.68 per subject year for on-demand treatment.