Tretten Generic Name & Formulations
Coagulation Factor XIII A-Subunit (recombinant) 2000–3125 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Single-use vials—1 (w. diluent, supplies)
Routine prophylaxis of bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency. Limitations of use: not for use in patients with congenital factor XIII B-subunit deficiency.
Tretten Dosage and Administration
Adults and Children
Give by IV inj at a rate of max 1–2mL/min. Initially 35 IU/kg once monthly to achieve a target trough FXIII activity level ≥10% using a validated assay. Consider dose adjustment if adequate coverage not achieved. Do not administer with other infusion solutions.
Tretten Boxed Warnings
Should be initiated under supervision of an experienced physician. Discontinue immediately and treat appropriately if anaphylaxis or hypersensitivity reactions occur. Conditions that predispose to thrombosis; monitor for signs/symptoms of thrombosis after administration. Measure FXIII inhibitory antibody concentrations if expected plasma FXIII activity levels not attained or if breakthrough bleeding occurs. Pregnancy (Cat. C). Nursing mothers.
Thrombosis risk with concomitant factor VIIa; avoid.
Tretten Adverse Reactions
Headache, pain in the extremities, injection site pain, increase in fibrin D-dimer levels; hypersensitivity reactions.
Tretten Clinical Trials
Tretten Patient Counseling