Tretten

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

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.

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. Do not use Tretten with recombinant factor VIIa, as this can increase your risk of blood clots.

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.

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. If needed for a small dose, it may be diluted with 0.9% sodium chloride. Do not inject Tretten any faster than 1 to 2 mL per minute. Throw away any Tretten left in the vial after you inject your dose because it may become unsterile.

It is important to store Tretten correctly.

Before preparing Tretten for injection

• Keep Tretten in a refrigerator at 36°F to 46°F (2°C to 8°C) and in the original package in order to protect it from light. Do not freeze Tretten.

After preparing Tretten for injection (reconstituted)

• Use Tretten immediately after it is dissolved (reconstituted) using the sterile water provided in the package. If you cannot inject it immediately, either leave Tretten at room temperature not above 25°C (77°F) or put Tretten in the refrigerator at 36°F to 46°F (2°C to 8°C) for no more than 3 hours. After more than 3 hours, DO NOT USE IT—THROW IT AWAY. Tretten does not contain a preservative. Do not store Tretten in the syringe or placed in the freezer.

Do not use Tretten for a condition for which it is not prescribed. Do not share Tretten with other people,even if they have the same symptoms that you have.

Talk to your healthcare provider if you would like more information.

Tretten ingredients include:

• Coagulation Factor XIII A-Subunit (Recombinant)
• Sodium Chloride
• Sucrose
• Polysorbate 20
• L-Histidine

Tretten and the sterile water vials provided in the package are not made with natural rubber latex.