Bleeding disorders:
Indications for: TRETTEN
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.
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 Warnings/Precautions:
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.
TRETTEN Classification:
Clotting factor.
TRETTEN Interactions:
Thrombosis risk with concomitant factor VIIa; avoid.
Adverse Reactions:
Headache, pain in the extremities, injection site pain, increase in fibrin D-dimer levels; hypersensitivity reactions.
How Supplied:
Single-use vials—1 (w. diluent, supplies)
