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Tretten Generic Name & Formulations
Legal Class
Rx
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)
Manufacturer
Tretten Indications
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
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
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
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