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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.