A PROVEN SAFETY PROFILE
The most common adverse reactions in clinical trials*:
- 1.8% Headache
- 1.8% Dizziness
- 0.9% Rash
- 0.9% Eczema
- 0.9% Hypersensitivity reaction
(nausea and tachycardia)
*In five 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 one 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. Twenty-seven 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 1,543.5 days (range: 25 to 2,565 days).
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.