Fc FUSION - THE SCIENCE BEHIND ELOCTATE
the science behind Fc Fusion1-5
A NATURAL PATHWAY TO PROLONGED HALF-LIFE
While some proteins can be broken down very quickly, it is believed Fc Fusion allows ELOCTATE to use your body's natural pathway to recycle and recirculate in the bloodstream longer.
Fc is part of a protein found in your body that's involved in the protein recycling process. Using science, we join Fc to B-domain deleted Factor VIII to prolong the half-life of Factor VIII. This is known as Fc Fusion. Based on pre-clinical studies, it is thought that:
SELECTED IMPORTANT SAFETY INFORMATION
- Your body can also make antibodies called, "inhibitors," against ELOCTATE, which may stop ELOCTATE from working properly.
Please see below for additional Important Safety Information and full Prescribing Information
- Mahlangu J, Powell JS, Ragni, MV: Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014;123: 317-325
- Powell JS, Josephson NC, Quon D, et al. Safety and prolonged activity of a recombinant factor VIII Fc fusion protein in hemophilia A patients. Blood. 2012;119:3031-3037.
- Rath T, Baker K, Dumont JA et al. Crit Rev Biotechnol. 2015;35:235-254.
- Lencer WI, Blumberg RS: A passionate kiss, then run: exocytosis and recycling of IgG by FcRn. Trends in Cell Biology. 2005;15 (1): 5-9.
- Shapiro A. Development of long-acting recombinant FVIII and FIX Fc fusion proteins for the management of hemophilia. Expert Opin Biol Ther 2013; 13(9):1287-1297.
Indications and Important Safety Information
ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.
Important Safety Information
Do not use ELOCTATE if you have had an allergic reaction to it in the past.
Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII.
Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.
Your body can also make antibodies called, "inhibitors," against ELOCTATE, which may stop ELOCTATE from working properly.
The most frequently occurring side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, and if bleeding is not controlled after using ELOCTATE.
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.