IDELVION HAS A PROVEN SAFETY PROFILE FOR CHILDREN, ADOLESCENTS, AND ADULTS WITH HEMOPHILIA B
Summary of Adverse Reactions in Previously Untreated Patients (PUPs)
Summary of Adverse Reactions in Previously Treated Patients (PTPs)
Summary of Adverse Reactions in Previously Untreated Patients (PUPs)
THE SAFETY OF IDELVION WAS ALSO EVALUATED IN A COMPLETED STUDY WITH 12 PUPS†
Adverse drug reactions were reported in 2 of 12 patients treated with IDELVION
- 1 patient (8.3%) developed a high titer of FIX inhibitors (peak titer 188 BU/mL) and the same patient developed hypersensitivity
- 1 patient (8.3%) developed rash
†Exposure days (EDs): Median number of EDs was 50 (range: 22 to 146) per patient. 8 patients achieved at least 50 EDs, of whom 3 patients achieved ≥100 EDs.
Summary of Adverse Reactions in Previously Treated Patients (PTPs)
MOST COMMON
ADVERSE REACTIONS IN CLINICAL TRIALS*:
REACTION
*In 5 multicenter, prospective, open-label clinical trials with IDELVION, 114 previously treated patients (PTPs; exposed to a Factor IX-containing product for ≥100 exposure days) received at least 1 infusion of IDELVION as part of on-demand treatment of bleeding episodes, perioperative management of major and minor surgical, dental, or other invasive procedures, routine prophylaxis, or pharmacokinetic evaluation. 27 children were <12 years of age, 9 adolescents were 12 to <18 years of age, and 78 adults were ≥18 to ≤65 years of age. A total of 16,326 injections were administered over a median of 1543.5 days (range: 25 to 2565 days).
Data from patients who started and stayed on prophylaxis prove IDELVION has powerful efficacy with both 7- and 14-day dosing‡
VIEW EFFICACY DATA†Once well-controlled (1 month without spontaneous bleeding or requiring dose adjustments on a weekly dose of ?40 IU/kg), people 12 years and older can be transitioned to 14-day dosing.
‡Of the 23 subjects in Arm 2, 19 were transitioned from on-demand to 7-day prophylaxis. The median AsBR during prophylaxis treatment was 0.7 (range: 0 to 4.2). Data for Arms 1 and 2 based on matched-pairs design.