Adverse reactions in the clinical study
B-LONG, a multi-center, prospective, open-label clinical trial (N=123) evaluated the safety and efficacy of ALPROLIX in 123 previously treated male patients with 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.