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Proven efficacy and safety profile1
Consistent activity observed over 52 weeks, as seen in mentor 11,2
(ages ≥6 years [N=41, 434 patient-months])
0 inhibitors occurred during mentor 1 and mentor 4 clinical trials.1
Half-life supports once-monthly dosing2
Provides adequate FXIII trough levels (>0.10 IU/mL) to support monthly treatment across all age groups (0.19 in mentor1; with a 35 IU/kg dose 0.21 in mentor 4)2,3
No dose adjustment required for pediatric patients (aged 1 to <6 years), as found in mentor 41
aBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug may not reflect the rates observed in practice.1
bMost commonly reported AEs in clinical trials were headache, pain in extremities, injection site pain, and increase in fibrin D dimer levels.
Study designs
mentor 1 clinical trial (Inbal A, et al.)
Patients studied: Patients with congenital FXIII A-subunit deficiency aged ≥6 years (mean, 26.4; range, 7-60) weighing ≥20 kg (N=41).
Study design: Multicenter, multinational, open-label, single-arm, multiple-dosing phase 3 trial where patients received monthly intravenous (IV) doses of Tretten® 35 IU/kg over a 52-week treatment period.
Primary endpoint: Mean annualized frequency of bleeding events requiring treatment with FXIII-containing products during the Tretten® prophylaxis treatment period versus the historical bleeding rate in patients with congenital FXIII deficiency treated on demand.2
mentor 4 clinical trial (Williams M, et al.)
Patients studied: Patients with congenital FXIII A-subunit deficiency aged 1 to <6 years weighing ≥10 kg (N=6).
Study design: Multicenter, multinational, open-label, nonrandomized trial investigating the pharmacokinetic (PK) properties and safety profile of Tretten® where patients received a single 35 IU/kg IV dose of Tretten® after a 4-week washout period of their previous prophylactic treatment.
Primary endpoint: To characterize the PK of recombinant FXIII (rFXIII) in children with congenital FXIII A-subunit deficiency following a single intravenous dose of Tretten® 35 IU/kg, by measuring the area under the concentration vs 30-day time curve (AUC0–30). Standard PK parameters were compared with those from mentor 1.3
Tretten® trial prescription program
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Considering Tretten® for your patients with congenital FXIII A-subunit deficiency?
To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoCare® Specialist.
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:
- Tretten [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
- Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D. Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012;119(22):5111-5117.
- Williams M, Will A, Stenmo C, Rosholm A, Tehranchi R. Pharmacokinetics of recombinant factor XIII in young children with congenital FXIII deficiency and comparison with older patients. Haemophilia. 2014;20(1):99-105.