Safety Profile of VPRIV

The most serious, and most commonly observed, adverse reactions in 94 patients treated with VPRIV in clinical studies were hypersensitivity reactions, including:1

  • headache, dizziness, hypo/hypertension, nausea, fatigue/asthenia, and pyrexia1

The most common adverse reactions during clinical studies (in ≥10% of adult and pediatric patients) were:1

ADVERSE REACTION NAÏVE TO ERT
n=54
n (%)
SWITCHED FROM
IMIGLUCERASE TO VPRIV
n=40
n (%)
Hypersensitivity reaction 28 (52) 9 (23)
Headache 19 (35) 12 (30)
Dizziness 12 (22) 3 (8)
Pyrexia 12 (22) 5 (13)
Abdominal pain 10 (19) 6 (15)
Back pain 9 (17) 7 (18)
Joint pain (knee) 8 (15) 3 (8)
Asthenia/fatigue 8 (15) 5 (13)
Activated partial thromboplastin time prolonged 6 (11) 2 (5)
Nausea 3 (6) 4 (10)

Across five pooled clinical studies of VPRIV, including initial phase I/II clinical trials

Denotes any event considered related to and occurring within up to 24 hours of VPRIV infusion, including one case of anaphylaxis

When further assessed during a long-term, open-label extension of Study 044, the majority of patients (>80%) experienced mild or moderate adverse events. Overall, the most common severe adverse events were osteonecrosis (3 patients) and arthralgia (2 patients).2

The safety profile of VPRIV was similar between pediatric patients and adult patients.1

TOLERABILITY Profile of VPRIV

IMMUNOGENICITY
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