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)