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TRETTEN
Bleeding disorders
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Drug Name:

TRETTEN Rx

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

Company:
Novo Nordisk

Therapeutic Use:

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.

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.

Interactions:

Thrombosis risk with concomitant factor VIIa; avoid.

Pharmacological Class:

Clotting factor.

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)

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