Tretten is an injectable medicine used to prevent bleeding in adults and children who have congenital factor XIII (FXIII) A-subunit deficiency. Tretten is man-made and does not contain animal or human materials.

Tretten is given as an injection into your vein (intravenous injection). These injections are given once a month. Your dose will depend on your body weight. Use the dose that your healthcare provider has prescribed for you based on your weight. Before injecting Tretten, it must be dissolved (reconstituted) using the sterile water that is provided in the package. Throw away any Tretten left in the vial after you inject your dose because it may become unsterile.

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. It is not known if Tretten can harm you or your unborn baby.
• Labor and Delivery: It is not known if Tretten is safe and effective during labor and delivery.
• Breast feeding: It is not known if Tretten passes into your breast milk.
• If you have a history of blood clots.

Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

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)
  • 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
• 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. You can also report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.