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VPRIVʼs safety and efficacy were studied in the largest clinical trial program of an ERT for type 1 Gaucher disease across three clinical trials (n=99; aged ≥4 years)1–3
Available data cannot definitively establish or exclude the absence of a VPRIV-associated risk
*While available data cannot definitively establish or exclude the absence of a VPRIV-associated risk during pregnancy, these data have not identified an association with the use of VPRIV during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes1,6
These data have been reported in the pharmacovigilance database and published observational cohort studies, including the International Collaborative Gaucher Group Registry.1,6
In clinical trials, VPRIV was evaluated in patients with genotypic mutations associated with mild to severe disease.7,8
Population by GBA† genotype before first dose in initial trials7
†The GBA gene is responsible for the production of the glucocerebrosidase
GBA, glucosylceramidase beta
IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions, including anaphylaxis, have occurred. The most serious adverse reactions in patients treated with VPRIV were hypersensitivity reactions.
Hypersensitivity reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. Patients were not routinely pre-medicated prior to infusion of VPRIV.