Dextran 75 and Factor XIII (Human)

• Generic Name: dextran, high molecular weight
• Dosage Forms: injection, powder, lyophilized, for solution
• Other Brand Names:

  Dextran 70 6% in 5% Dextrose, Hyskon, Macrodex, Gentran 70, Dextran-HM, Dextran 70 6% in 09% Sodium Chloride

High-molecular weight dextran is a plasma volume expander made from natural sources of sugar (glucose). It works by restoring blood plasma lost through severe bleeding. Severe blood loss can decrease oxygen levels and can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Dextran is used to treat hypovolemia (decreased volume of circulating blood plasma), that can result from surgery, trauma or injury, severe burns, or other causes of bleeding.

Dextran may also be used for purposes not listed in this medication guide.

• 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.