Low incidence of adverse reactions in clinical trials

5 of 111 patients reported an adverse reaction with IDELVION*

1.8% HEADACHE

0.9% DIZZINESS

0.9% RASH

0.9% ECZEMA

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.

Up to 14-day dosing with IDELVION

Dosing schedule that meets your patients' needs

VIEW FULL DOSING INFORMATION

ZERO BLEEDS in prophylaxis with IDELVION in clinical trials

Zero median annualized spontaneous bleeding rate (AsBR) when dosed at 7 and 14 days in clinical trials

VIEW THE EFFICACY DATA

‡In appropriate patients 12 years and older.

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