Factor XIII (Human) and Thromboembolic complications

• Generic Name: factor XIII
• Dosage Forms: n.a.
• Other Brand Names: Corifact, Tretten

Routine prophylaxis and perioperative management of bleeding in patients with congenital factor XIII deficiency; designated an orphan drug by FDA for treatment of congenital factor XIII deficiency.

Initial FDA-labeled use based on trough factor XIII levels (5–20%) as a surrogate measure of efficacy; clinical benefit (i.e., prevention of bleeding episodes) established in a postmarketing study.

Prophylactic therapy with factor XIII concentrates is recommended in all patients with severe (<1% factor XIII activity) deficiency; considered current standard of care.

Currently available factor XIII concentrates in the US include a plasma-derived (Corifact) and a recombinant (Tretten) preparation. Some experts recommend preferential use of recombinant preparations because of their potentially superior safety profile with respect to pathogen transmission. (See Risk of Transmissible Agents in Plasma-derived Preparations under Cautions.) When selecting an appropriate factor XIII preparation, consider characteristics of each clotting factor concentrate in addition to individual patient variables.

Has been used to treat acquired factor XIII deficiency associated with various diseases or other conditions.