Data from FDA - Curated by Toby Galbraith - Last updated 19 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency.

TRETTEN is not for use in patients with congenital factor XIII B-subunit deficiency.

Full Prescribing information

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Advisory information

contraindications
Hypersensitivity to the active substance or to any of the excipients. (4)
Special warnings and precautions

• Discontinue if allergic or hypersensitivity reactions occur. (5.1)
• Monitor patients for thrombosis. (5.2)
• Analyze for neutralizing antibodies if FXIII activity fails to reach expected levels or if reduced therapeutic effect is observed. (5.3)

Adverse reactions

The most common adverse reactions reported in the clinical trials (≥1%) were headache, pain in the extremities, injection site pain, D dimer increase. (6)

Usage information

Dosing and administration

For intravenous use only.

Dose:
• 35 international units per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay. (2.1)
• Consider dose adjustment if adequate coverage is not achieved with a 35 IU/kg dose. (2.1)
• Once reconstituted, TRETTEN may be diluted with 0.9% sodium chloride to facilitate measurement of small volumes. (2.2)

Rate: Do not exceed 1-2 mL per minute. (2.3)

Use in special populations
Pregnancy: No human or animal data available. Use only if clearly needed. (8.1)

Interactions

Do not administer TRETTEN with recombinant factor VIIa.

More information

Category Value
Authorisation number BLA125398
Orphan designation No
Product NDC 0169-7013
Date First Approved 23-12-2013
Marketing authorisation holder Novo Nordisk

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