Exenatide and Factor XIII (Human)

• Generic Name: exenatide
• Dosage Forms: n.a.
• Other Brand Names:

  Byetta Prefilled Pen, Bydureon, Bydureon BCise, Bydureon Pen, Bydureon Tray

This medication guide provides information about the Byetta brand of exenatide. Bydureon is another brand of exenatide that is not covered in this medication guide.

Exenatide is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently. Byetta is a short-acting form of exenatide.

Byetta is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Byetta is not for treating type 1 diabetes.

Byetta 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.