VPRIV Patient Population
Real-world data are available regarding the use of VPRIV in over 300 pregnancies; the use of VPRIV has not been associated with adverse outcomes in pregnancy.*
These data have been reported from a database that tracks the safety of VPRIV (a pharmacovigilance database) and published observational studies, including the international Gaucher Disease registry.*Although the 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 outcomes.
What is a pharmacovigilance database?
After a drug is approved, pharmaceutical companies are required to keep a record of all safety data that are reported globally in a central repository (a pharmacovigilance database). Adverse events reported may or may not be a direct result of taking the medicine. The overall data collected helps evaluate the risk versus benefit profile of the medicine.
Talk to your doctor if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed. You can then discuss your treatment plan with VPRIV and any concerns you may have about pregnancy or breastfeeding and treatment. Further advice on how to steer conversations with your doctor can be found here.
The safety and efficacy of VPRIV have been established in children aged 4–17 years with type 1 Gaucher disease. VPRIV was evaluated in 24 children (aged 4–17 years) in a clinical trial, the 5-year long-term extension study. Learn more about this pediatric subgroup here.
The safety profile of VPRIV was similar between children (aged 4–17 years) and adults. The safety of VPRIV has not been established in children younger than 4 years of age.
Rash, increased time it takes for blood to clot, and fever were side effects more commonly seen in children than in adults.
In clinical studies of VPRIV treatment for Type 1 Gaucher disease, 56 VPRIV-treated patients were 65 years of age or older, including 10 patients who were 75 years of age or older.
Older patients (≥65 years old) had similar adverse reactions to those in children and adults.
In general, doses for older patients should be selected cautiously by their doctors, taking into consideration any other existing or potential medical conditions.