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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

What makes Tretten® different?

Mark has congenital
FXIII deficiency

Previous treatments for congenital FXIII A-subunit deficiency were limited to plasma-derived products accompanied by the risk of infectious-agent contamination.1,2 But Tretten® is recombinant, so it is made without human- or animal-derived products.3

Tretten® displays the same pharmacodynamic properties as human FXIII when it binds with the body's FXIII B-subunit, and has been shown to effectively prevent bleeding through once-monthly, low-volume prophylaxis.3,a

Molecule icon

The only recombinant therapy for congenital FXIII A-subunit deficiency3

Low ABR

Proven efficacy and safety in clinical trials3,b

28 Days

Convenient once-monthly, low-volume prophylaxis3,a

ABR=annualized bleeding rate.
aIn patients with congenital FXIII A-subunit deficiency.
bTretten® showed a statistically significant lower ABR compared with the historical control of on-demand treatment (0.14 vs 1.68 bleeds, respectively).3

Keep patients protected with convenient once-monthly, low-volume infusions3

With up to 15 times less volume per infusion, Tretten® takes under 2 minutes once every 28 days to infuse—less than 26 minutes per year.3,4

Up to 15x less volumec

up to 3 ml
up to 43 ml

Up to 7x faster infusionc

up to 1.5 minutes
up to 11 minutes

cDosages based on a 70-kg person infusing 35 IU/kg from a nominally 2500-IU vial of Tretten® at 2 mL/minute or 40 IU/kg from a 1300-IU vial of plasma-derived FXIII concentrate at 4 mL/minute.

Recommended dosing3

Tretten® vial
  • Tretten® is available in single-use vials containing nominally 2500 IU (2000 IU to 3125 IU) of lyophilized powder.
  • The recommended dose for routine prophylaxis for bleeding in patients with congenital FXIII A-subunit deficiency is 35 IU/kg body weight, administered as a once-monthly IV bolus injection.
    • No dose adjustment is required for pediatric patients (aged 1 to < 6 years), as found in mentor™4.
    • If adequate coverage is not achieved with a 35 IU/kg dose, consider dose adjustment to reach a target trough level ≥10% using a validated assay.
    • For smaller doses requiring less than a full vial, further dilute Tretten® with 0.9% sodium chloride—discard remaining product.

How to store Tretten®

Storage temperature

Before reconstitution

Refrigerate at 36°F to 46°F—do not freeze—and keep away from direct light until ready for reconstitution.3

Garbage icon

After reconstitution

Use immediately—however, storage at room temperature (up to 77°F) or in a refrigerator (do not freeze) for up to 3 hours is acceptable if necessary. After 3 hours, discard any reconstituted Tretten®.3

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. National Hemophilia Foundation. MASAC recommendation regarding the use of recombinant clotting factor products with respect to pathogen transmission. Approved April 13, 2014. Adopted May 6, 2014. Accessed February 16, 2022. http://www.hemophilia.org/sites/default/files/document/files/masac-226.pdf
  2. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. Approved August 8, 2020. Adopted September 3, 2020. Accessed February 16, 2022. https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-263-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-other-bleeding-disorders
  3. Tretten [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  4. Corifact [package insert]. Kankakee, IL: CSL Behring LLC; 2019.