5 OF 111 PATIENTS REPORTED AN ADVERSE REACTION WITH IDELVION*
0.9% HYPERSENSITIVITY REACTION (NAUSEA and TACHYCARDIA)
IDELVION was evaluated for safety
- No reports of inhibitor development against FIX or treatment-emergent antibodies to IDELVION in the clinical trials*
- No signs or symptoms of thrombosis†
*In five multicenter, prospective, open-label clinical trials with IDELVION, 111 previously treated patients (PTPs; exposed to an FIX-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 75 adults were ≥18 to ≤65 years of age. A total of 8,274 injections were administered over a median of 600 days (range: 25 to 1,288 days).
†Thromboemolism (eg, pulmonary embolism, venous thrombosis, and arterial thrombosis) can occur when using FIX-containing products.