Novo Nordisk is pleased to announce that the US Food and Drug Administration (FDA) has approved TRETTENĀ® (Coagulation Factor XIII A-Subunit [Recombinant]) for the routine prophylaxis of bleeding in people with congenital factor XIII (FXIII) A-subunit deficiency, one of the rarest inherited bleeding disorders. TRETTENĀ® is the only recombinant treatment for the disease. Patients with congenital FXIII A-subunit deficiency have a lifelong susceptibility towards bleeding, including spontaneous bleeding into the brain called intracranial hemorrhage, which, if not treated, could be life-threatening.1 TRETTENĀ® has been proven safe and effective and will offer patients once-monthly dosing with a short infusion time.
The FDA approved TRETTENĀ® based on results from a clinical program that demonstrated the safety and efficacy of TRETTENĀ®. The phase 3 trial that included 41 patients showed that when compared with a historic control group of individuals who did not receive routine FXIII infusions, preventive treatment with monthly 35 IU/kg TRETTENĀ® injections significantly decreased the number of bleeding episodes that required treatment.
The approval of TRETTENĀ® is another example of Novo Nordiskās commitment to bringing new treatment options to people living with rare bleeding disorders. At this time, we anticipate TRETTENĀ® will be available in early 2014.
We are providing this information to you in the event patients or caregivers contact you with questions about TRETTENĀ®.
Indications and Usage
What is TRETTENĀ® (Coagulation Factor XIII A-Subunit [Recombinant])?
Ā· TRETTENĀ® is an injectable medicine used to prevent bleeding in adults and children who have congenital factor XIII (FXIII) A-subunit deficiency.
Important Safety Information
Who should not use TRETTENĀ®?
Ā· You should not use TRETTENĀ® if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reaction (anaphylaxis) to TRETTENĀ® or any of the ingredients.
What should I tell my healthcare provider before TRETTENĀ® 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 TRETTENĀ®?
Ā· Call your healthcare provider or the emergency department right away if you have any of the following symptoms after using TRETTENĀ®:
o Signs of allergic reaction, including shortness of breath, rash, itching (pruritus), redness of the skin (erythema), and fainting/dizziness.
o 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.
o Unexpected bleeding.
Ā· Other possible side effects may include pain in your arms or legs, headache, and pain at the injection site.
Ā· These are not all the possible side effects of TRETTENĀ®. Tell your healthcare provider about any side effect that bothers you or that does not go away.