• Bleeding disorders

Tretten Generic Name & Formulations

General Description

Coagulation Factor XIII A-Subunit (recombinant) 2000–3125 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Pharmacological Class

Clotting factor.

How Supplied

Single-use vials—1 (w. diluent, supplies)


Tretten Indications


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 Contraindications

Not Applicable

Tretten Boxed Warnings

Not Applicable

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 Pharmacokinetics

See Literature

Tretten Interactions


Thrombosis risk with concomitant factor VIIa; avoid.

Tretten Adverse Reactions

Adverse Reactions

Headache, pain in the extremities, injection site pain, increase in fibrin D-dimer levels; hypersensitivity reactions.

Tretten Clinical Trials

See Literature

Tretten Note

Not Applicable

Tretten Patient Counseling

See Literature