Tretten

Generic name:Coagulation Factor XIII A-Subunit (Recombinant)
Drug class:Miscellaneous coagulation modifiers
Approval date: December 23,2013
Company: Novo Nordisk A/S

Treatment for: Factor XIII A-Subunit Deficiency

FDA Approves Tretten

The U.S. Food and Drug Administration (FDA) has approved Tretten (Coagulation Factor XIII A-Subunit [Recombinant]) for the routine prophylaxis of bleeding in people with congenital factor XIII (FXIII) A-subunit deficiency.

Tretten Petient Information

This leaflet summarizes important in formation about Tretten. Please read it carefully before using Tretten and each time you get a refill because there may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Tretten.

If you have any questions after reading this, ask your healthcare provider.

What is Tretten?

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.

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. 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.

How is Tretten given?

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.

Tretten side effects

Call your healthcare provider or go to the emergency department right away if you have any of th...