Proven protection* from bleeds
*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.
was 13.8 days.
- Your body can also make antibodies called “inhibitors” against ALPROLIX, which may stop ALPROLIX from working properly
- ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider or seek emergency care if you have symptoms of a possible abnormal blood clot, which may include: chest pain, difficulty breathing, unexpected swelling of an arm or leg with or without pain or tenderness.
severe hemophilia B, ages 12-71 (Factor IX activity 2% or less). Followed for up to 77 weeks, multiple characteristics of ALPROLIX were assessed, including
safety, efficacy, and pharmacokinetics:1-4
- In the once-weekly group, 63 people were given an initial dose of 50 IU/kg, which was adjusted to maintain desired Factor IX levels.
- In the individualized prophylaxis group, 29 people were initially given 100 IU/kg every 10 days and their intervals were adjusted to maintain desired Factor IX levels.
- In the on-demand group, 27 people infused as needed with doses ranging between 20 to 100 IU/kg depending on the severity of the bleed.
- In the surgical group, 12 people received ALPROLIX for bleed management in 14 major surgeries. 15 minor surgeries were also evaluated. Doses were adjusted
according to the type of surgery. 4 people in this group did not participate in the other groups.
- Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant Factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323.
- US Food and Drug Administration. The FDA's drug review process: ensuring drugs are safe and effective.
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm.Accessed June 19, 2013.
- Pharmaceutical Research and Manufacturers of America. The research and development process. http://www.phrma.org/research-development-process.
Accessed June 19, 2013.
- Ator MA, Mallamo JP, Williams M. Overview of drug discovery and development. Curr Protoc Pharmacol. 2006;9(35):9.9.1-9.9.26.