Factor XIII

(BAN, USAN, rINN)

💊 Chemical information

Fibrin-stabilising Factor; FSF.
ATC — B02BD07.
ATC Vet — QB02BD07.

💊 Profile

Factor XIII is used as replacement therapy in patients with a genetic deficiency of factor XIII. It may also be used in patients with acquired deficiency of factor XIII, and for supportive therapy in postoperative wound healing. Dosage of factor XIII is based on the degree of deficiency and the condition of the patient. For prophylaxis of haemorrhage in patients with genetic deficiency about 10 units/kg may be given intravenously once a month. The interval between doses may be shortened if spontaneous haemorrhage occurs. For pre-operative use, a dose of up to 35 units/kg may be given immediately before the operation and followed by adequate doses to maintain efficacy until the wound is healed. For the treatment of severe bleeding episodes 10 to 20 units/kg should be given daily, until bleeding stops. In acute bleeding, especially intracranial bleeding, doses of up to 50 units/kg may be needed to raise factor XIII to normal levels. Doses of at least 15 to 20 units/kg may be required for the treatment of haemorrhage in acquired factor XIII deficiency. In the promotion of postoperative wound healing, a dose of 10 units/kg may be given on the day of the operation and on each of the next 3 days. Like other clotting factor preparations, the use of factor XIII may be associated with risks of hypersensitivity reactions, thrombosis, and viral infection transmission; inhibitors of factor XIII may occur very rarely. Cryoprecipitate is also used as a source of factor XIII. Factor XIII is also a component of fibrin glues.

Inflammatory bowel disease.

Some patients with inflammatory bowel disease may be deficient in factor XIII, possibly due to increased intestinal blood loss seen in severe ulcerative colitis or increased mucosal deposition of factor XIII in Crohn’s disease. Factor XIII concentrate given intravenously has produced beneficial results in 12 patients with active ulcerative colitis resistant to conventional therapy with corticosteroids and mesalazine1 and has also been associated with healing of intractable fistulae in 3 of 4 patients with Crohn’s disease.2 However, a controlled study3 found no benefit from factor XIII in active corticosteroid-refractory ulcerative colitis.
1. Lorenz R, et al. Factor XIII substitution in ulcerative colitis. Lancet 1995; 345: 449–50
2. Oshitani N, et al. Treatment of Crohn’s disease fistulas with coagulation factor XIII. Lancet 1996: 347: 119–20
3. Bregenzer N, et al. Lack of clinical efficacy of additional factor XIII treatment in patients with steroid refractory colitis. Z Gastroenterol 1999; 37: 999–1004.

Wounds and ulcers.

Topical factor XIII has been reported to promote wound healing in patients with refractory leg ulcers.1-3
1. Wozniak G, et al. Factor XIII in ulcerative leg disease: background and preliminary clinical results. Semin Thromb Hemost 1996; 22: 445–50
2. Herouy Y, et al. Factor XIII-mediated inhibition of fibrinolysis and venous leg ulcers. Lancet 2000; 355: 1970–1
3. Hildenbrand T, et al. Treatment of nonhealing leg ulcers with fibrin-stabilizing factor XIII: a case report. Dermatol Surg 2002; 28: 1098–9.

💊 Preparations

Ph. Eur.: Fibrin Sealant Kit.

Proprietary Preparations

Arg.: Fibrogammin P; Austria: Fibrogammin; Belg.: Fibrogammin; Braz.: Fibrogammin; Cz.: Fibrogammin P†; Ger.: Fibrogammin; Hong Kong: Fibrogammin P; Israel: Fibrogammin P; Switz.: Fibrogammin; UK: Fibrogammin P. Multi-ingredient: Arg.: Beriplast P; Tissucol; Tissucol Duo Quick†; Austral.: Tisseel Duo; Austria: Beriplast; Tissucol; Tissucol Duo Quick; Belg.: Tissucol Duo; Braz.: Beriplast P; Canad.: Tisseel; Chile: Beriplast P; Cz.: Tissucol; Denm.: Tisseel Duo Quick; Fin.: Tisseel Duo Quick; Fr.: Beriplast; Tissucol; Ger.: Beriplast; Tissucol Duo S; Tissucol-Kit; Gr.: Beriplast P; Hong Kong: Beriplast P; Tisseel; Hung.: Beriplast P; Tissucol-Kit; Indon.: Beriplast; Israel: Beriplast; Tisseel; Ital.: Beriplast; Mex.: Beriplast P; Tissucol†; Neth.: Beriplast P; Tissucol; Tissucol Duo; Pol.: Beriplast; Port.: Tissucol Duo; Spain: Beriplast P Combi; Tissucol Duo; Swed.: Tisseel Duo Quick; Switz.: Beriplast P; Tissucol; Tissucol Duo S; Turk.: Beriplast P; UK: Tisseel.
Published November 30, 2018.