VPRIV is available by prescription only.
Indication
VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease.
Important Safety Information
- The most serious side effects seen in patients in clinical trials with VPRIV were allergic reactions. Patients who have experienced allergic reactions to VPRIV or to other enzyme replacement therapy should proceed with caution.
- The most common side effects observed in clinical trials in patients treated with VPRIV were infusion-related and included: headache, dizziness, low blood pressure, high blood pressure, nausea, weakness/fatigue, and fever. Generally, infusion-related reactions were mild and, in newly treated patients, occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
- Management of infusion-related reactions is based on severity and may include slowing the infusion rate, treatment with medications such as antihistamines, fever-reducing agents and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time. Side effects and any treatment concerns should be discussed with your physician.
- The most commonly reported side effects (occurring in ≥10% of patients) that were considered related to VPRIV included: headache, dizziness, abdominal pain, nausea, back pain, joint pain, upper respiratory tract infection, aPTT prolonged (eg, blood clotting difficulty), infusion-related reactions, fever, and weakness/fatigue.
- All adult side effects of VPRIV are considered relevant to children (ages 4 to 17 years). Side effects more commonly seen in children compared with adult patients included: upper respiratory tract infection, rash, aPTT prolonged, and fever. The safety of VPRIV has not been established in patients younger than 4 years of age.
- As with all therapeutic proteins, there is the potential of developing antibodies. It is unknown if the presence of antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other enzyme replacement therapies who are switching to VPRIV should continue to be monitored for antibodies.
- Your doctor may prescribe VPRIV to you if you are pregnant, only if it is clearly necessary.
- Tell your healthcare provider if you experience any side effects. For more information about VPRIV, ask your healthcare provider, read the Full Prescribing Information, visit www.VPRIV.com, or call Shire at 1-866-888-0660.
- You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
