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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

  • The safety and efficacy of VPRIV has not been established in pediatric patients younger than 4 years of age.1

  • Adverse reactions more commonly seen in pediatric patients compared with adult patients (>10% difference) included rash, prolonged aPTT, and pyrexia.1

  • The adverse reaction profile in elderly patients was consistent with that previously observed across pediatric and adult patients.1

TOLERABILITY Profile of VPRIV

  • VPRIV does not have any drug–drug interactions or contraindications listed in the package insert.1

    • In general, dose selection for an elderly patient should be approached cautiously, considering comorbid conditions.1

  • In the 5-year, long-term extension study (044), no patient discontinued VPRIV due to an adverse event.2

    • In post-marketing experience, vomiting was reported (in some cases vomiting can be serious, requiring hospitalization and/or drug discontinuation).1

IMMUNOGENICITY

  • Across clinical trials VPRIV had low rates of immunogenicity.

    • 1 in 54 (2%) of treatment-naïve patients treated with VPRIV developed IgG class antibodies (neutralizing in an in vitro assay).1

    • One additional patient developed IgG antibodies to VPRIV during an extension study. In both patients, the IgG antibodies to VPRIV were determined to be neutralizing in an in vitro assay. The presence of IgG antibodies to VPRIV was not associated with hypersensitivity reactions.1

    • It is unknown if the presence of IgG antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other ERTs who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.1

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VPRIV Clinical Trials
VPRIV Patient Population
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(1-877-825-3327), or by e-mail at medinfous@takeda.com.

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