VPRIV SAFETY &
TOLERABILITY PROFILE
SAFETY PROFILE OF VPRIV
The most serious, and most commonly observed, adverse reactions in 94 patients treated with VPRIV (velaglucerase alfa) in clinical studies were hypersensitivity reactions, including1:
- Headache, dizziness, hypo/hypertension, nausea, fatigue/asthenia, and pyrexia1
The most common adverse reactions observed across five pooled clinical studies of VPRIV (in ≥10% of adult and pediatric patients aged ≥4 years) were1:
| 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) |
*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 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 have not been established in pediatric patients younger than 4 years of age1
- Adverse reactions more commonly seen in pediatric patients compared to adult patients (>10% difference) included rash, aPTT prolonged, and pyrexia1
- The adverse reaction profile in elderly patients was consistent with that previously observed across pediatric and adult patients1
TOLERABILITY PROFILE OF VPRIV
-
VPRIV does not have any listed drug–drug interactions or contraindications in the Prescribing Information (or Package Insert)1
- In general, dose selection for an elderly patient should be approached cautiously, considering comorbid conditions1
-
In the 5-year, long-term extension study (044), no patient discontinued VPRIV due to an adverse event2
- In post-marketing experience, vomiting was reported (in some cases vomiting can be serious, requiring hospitalization and/or drug discontinuation)1
IMMUNOGENICITY
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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 reactions1
- 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 VPRIV1
