"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
TRETTEN, Coagulation Factor XIII A-Subunit
TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is a recombinant human factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits. The FXIII A-subunit is a 731 amino acid chain with an acetylated N-terminal serine. When FXIII is activated by thrombin, a 37 amino acid peptide is cleaved from the N-terminus of the A-subunit.
TRETTEN is manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography. No human or animal derived products are used in the manufacturing process.
TRETTEN is supplied as a sterile, white lyophilized powder in a single use vial. Table 1 and Table 2 list the vial content of reconstituted TRETTEN and the diluent, respectively.
Table 1 : Content of Reconstituted TRETTEN*
|Coagulation Factor XIII A-Subunit (Recombinant)||2000 - 3125 IU||Active substance|
|Sodium Chloride||8.70 mg||Stabilizer|
|Polysorbate 20||0.30 mg||Surfactant|
|* Values are given per 3 mL reconstituted TRETTEN.|
Table 2 : Content of Diluent for Reconstitution of TRETTEN
|Sterile Water for Injection||3.2 mL||Diluent|
After reconstitution with 3.2 mL sterile water for injection, each vial contains 667-1042 IU/mL of recombinant coagulation factor XIII A-subunit. The reconstituted solution has a pH of approximately 8.0. The formulation contains no preservative and must only be administered intravenously.
Last reviewed on RxList: 4/5/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Tretten Information
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