Prophylaxis infusion schedules – starting every 7 or 10 days with the potential to extend based on your response
"After working with my doctor and based on my response, I now infuse prophylactically every 14 days."
to extend based on your response
- ALPROLIX has a prolonged half-life allowing for a recommended starting prophy regimen of either 50 IU/kg once-weekly, or 100 IU/kg once every 10 days. Dosing regimen can be adjusted based on individual response.
- Based on your response you may be able to extend your dosing interval
- In the clinical trial, the overall median interval for the individualized prophylaxis arm was 12.5 days. The median interval during the lastsix months in 26 subjects who were on study for at least nine months was 13.8 days.
The amount of time that ALPROLIX is active may be different in children. Children under 12 may have a shorter half-life and lower recovery. Therefore, higher doses or more frequent infusions may be needed.
- Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX.
- Allergic reactions may occur with ALPROLIX. 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.
Children under 12 years of age may have higher Factor IX body weight-adjusted clearance, shorter half-life, and lower recovery. Higher dose per kilogram body weight or more frequent dosing may be needed in these children.
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.