PROPHYLAXIS: Only IDELVION offers powerful bleed protection and is FDA approved for up to 14-day dosing
- In the clinical trials, 21 subjects were transitioned from 7-day to 14-day prophylaxis. The median annualized spontaneous bleeding rates (AsBR) for each dose were zero and zero, respectively
- When dosed every 7 days, interquartile range (IQR)* was 0.0–0.0 bleeds
- When dosed every 14 days, IQR was 0.0–1.0 bleeds
*IQR is the middle 50% of people in a clinical study and is used as a more accurate measure
of expected range.
†Data based on a matched-pairs design.
Phase II/III study design: The safety and efficacy of IDELVION were evaluated in a prospective, open-label, multicenter clinical study of 63 male PTPs with hemophilia B (≤2% endogenous FIX activity) who received at least one infusion of IDELVION. Subjects were aged 12 to 61 years; including 7 adolescent subjects aged 12 to 17. Subjects were treated for up to 27 months.
Forty subjects received weekly routine prophylaxis. Thirty-seven subjects completed 6 months of once-weekly prophylaxis. Of these, 21 subjects switched to a 14-day interval with 50–75 IU/kg of IDELVION.
Twenty-three subjects received IDELVION only for the treatment of bleeding episodes during the first 6 months of the study. Nineteen switched to once-weekly prophylaxis with additional median duration of 10 months.
7- and 14-DAY PROPHYLAXIS†
ON-DEMAND: IDELVION achieves high trough levels for more than 2 weeks with a single dose in patients ≥12 years
A majority of bleeds resolved within 1–2 infusions:
- 94% of bleeds resolved with 1 infusion
- 99% of bleeds resolved within 1–2
‡After administration of a single infusion of IDELVION.
§Data from the phase I trial, a first-in-human prospective, multicenter, open-label dose-escalation study to evaluate the safety and PK of 25, 50, and 75 IU/kg rIX-FP in subjects with hemophilia B. Twenty-five subjects were enrolled in order to ensure at least 13 evaluable subjects in the 50 IU/kg dosing group, and at least 4 evaluable subjects in both the 25 and 75 IU/kg rIX-FP dosing groups. All subjects received rIX-FP in a non-bleeding state and after a washout period of at least 4 days from their last dose of the previous FIX product.1
PERIOPERATIVE MANAGEMENT: IDELVION has excellent hemostatic response in surgery‖
of rated surgeries were excellent or good for hemostatic efficacy
‖In 3 clinical studies, 13 subjects received IDELVION for perioperative management of 15 surgical procedures
Patient population included:
- 10 previously treated patients (PTPs) between 12 and 61 years of age
- 3 surgical procedures in 3 children ≤12 years old
“Before my surgery we discussed the right IDELVION dosage options. Doing what I could to control the outcome and improve results felt good.”
Tony recovered from ankle replacement surgery while on IDELVION
Reference: 1. Santagostino E, Negrier C, Klamroth R, et al. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. doi:10.1182/blood-2012-05-429688.