Tretten® is an injectable product used to prevent bleeding in adults and children who have congenital FXIII A-subunit deficiency. It does this by maintaining the body's FXIII activity levels, helping to make clots stronger and less likely to dissolve.
The only recombinant therapy for congenital factor XIII (FXIII) A-subunit deficiency1
Andy has congenital factor XIII deficiency
Different by design
Before Tretten®, all products for congenital FXIII A-subunit deficiency were made from plasma or blood products.
Tretten® is different because it is recombinant, which means it was made in a laboratory without any human or animal materials. It was designed to act just like the body’s natural factor XIII A-subunit as it helps form stable clots.
Proven safe and effective in clinical trials
In clinical trials, Tretten® was:
- Shown to be safe and effective when used monthly
- Effective in reducing the rate of bleeding
Fast once-monthly, low-volume infusiona
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.
Up to 15x less volumeb
Tretten®
Plasma-derived factor XIII concentrate
Up to 7x faster infusionb
Tretten®
Plasma-derived factor XIII concentrate
aIn people with congenital factor XIII A-subunit deficiency.
bDosages based on a 70-kg (154-lb) 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 factor XIII concentrate at 4 mL/minute.
Tretten®—purely because you are one in a million
The only recombinant therapy
for congenital factor XIII
A-subunit deficiency
Proven safe and effective in clinical trials
Convenient once-monthly,
low-volume prophylaxisa
ABR=annualized bleeding rate.
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Selected Important Safety Information
Who should not use Tretten®?
- You should not use Tretten® if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reaction (anaphylaxis) to Tretten® or any of the ingredients.
What should I tell my healthcare provider before Tretten® is given?
- Tell your healthcare provider about all of your medical conditions, including if you are pregnant, think you may be pregnant or planning to become pregnant, are breast feeding, or have a history of blood clots.
- Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.
Indications and Usage
What is Tretten® (Coagulation Factor XIII A-Subunit [Recombinant])?
- Tretten® is an injectable medicine used to prevent bleeding in adults and children who have congenital Factor XIII (FXIII) A-subunit deficiency.
- Tretten® is not for use in patients with congenital Factor XIII B-subunit deficiency.
Important Safety Information
Who should not use Tretten®?
- You should not use Tretten® if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reaction (anaphylaxis) to Tretten® or any of the ingredients.
What should I tell my healthcare provider before Tretten® is given?
- Tell your healthcare provider about all of your medical conditions, including if you are pregnant, think you may be pregnant or planning to become pregnant, are breast feeding, or have a history of blood clots.
- Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.
What are the possible side effects of Tretten®?
- Call your healthcare provider or go to the emergency department right away if you have any of the following symptoms after using Tretten®:
- Signs of allergic reaction, including shortness of breath, rash, itching (pruritus), redness of the skin (erythema), or fainting/dizziness.
- Signs of a blood clot including pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, or sudden severe headache and/or loss of consciousness or function.
- Unexpected bleeding.
- Other possible side effects may include pain in your arms or legs, headache, and pain at the injection site.
- These are not all the possible side effects of Tretten®. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Please click here for Tretten® Prescribing Information.
Tretten® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.