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Medical Information | Non-US Health Care Professionals
Important Safety Information
Prescribing Information
Tretten® (coagulation factor XIII A-subunit [recombinant]) logo

For routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

Prescribing Information
Important Safety Information

Purely because they are one in a million1

Tretten® is the only recombinant therapy approved for congenital FXIII A-subunit deficiency, a very rare autosomal recessive bleeding disorder that occurs ≈1 in every 3 to 5 million people.2-5

Manny has
congenital
FXIII
deficiency

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Efficacy and safety of Tretten®

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Helping your patients with congenital FXIII A-subunit deficiency

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Learn more about Tretten® dosing and storage

Tretten® Lab Program Form
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MASAC

The Medical and Scientific Advisory Council (MASAC) recommends the use of Tretten® for patients with congenital FXIII A-subunit deficiency.6

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Selected Important Safety Information for Tretten®

Tretten® is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

Tretten® may cause allergic reactions. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute appropriate treatment.

Indications and Usage

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.

Important Safety Information

Tretten® is contraindicated in patients with hypersensitivity to the active substance or to any of the exicipients.

Tretten® may cause allergic reactions. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute appropriate treatment.

Thromboembolic complications may occur. Monitor patients with conditions that predispose to thrombosis for signs and symptoms of thrombosis after administration of Tretten®.

Inhibitory antibodies may occur with Tretten®. Patients with inhibitory antibodies may manifest as an inadequate response to treatment. If expected plasma FXIII activity levels are not attained, or if breakthrough bleeding occurs while receiving prophylaxis, perform an assay that measures FXIII inhibitory antibody concentrations.

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

Thrombosis may occur if Tretten® is administered concomitantly with Factor VIIa.

There are no adequate and well-controlled studies using Tretten® in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with Tretten®.

Please click here for Tretten® Prescribing Information.

References:

  1. Kohler HP, Ichinose A, Seitz R, Ariens RAS, Muszbek L; Factor XIII and Fibrinogen SSC Subcommittee of the ISTH. Diagnosis and classification of factor XIII deficiencies. J Thromb Haemost. 2011;9(7):1404-1406.
  2. Tretten [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020. 
  3. U.S. Food and Drug Administration. Licensed biological products with supporting documents. FDA Web Site. Updated August 23, 2021. Accessed February 16, 2022. https://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents
  4. Hsieh L, Nugent D. Factor XIII deficiency. Hemophilia. 2008;14:1190-1200. 
  5. Board PG, Losowky MS, Miloszewski KJA. Factor XIII: inherited and acquired deficienty. Blood Rev. 1993;7:229-242.
  6. National Hemophilia Foundation. MASAC recommendation regarding the use of recombinant clotting factor products with respect to pathogen transmission. http://www.hemophilia.org/sites/default/files/document/files/masac-226.pdf