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Data Presented at the European Working Group on Gaucher Disease Demonstrate Continuous Improvements in Bone Mineral Density for VPRIV(R) (Velaglucerase Alfa) Through 69 Months
Date:7/1/2010

For full US prescribing information see www.vpriv.com

Important Safety Information

The most serious adverse reactions in patients treated with VPRIV were hypersensitivity reactions. 

Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia.  Generally the infusion-related reactions were mild and, in treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.  Other commonly observed adverse reactions in >10% of patients were: abdominal pain, back pain, joint pain, upper respiratory tract infection, and activated partial thromboplastin time prolonged.  Adverse reactions more commonly seen in pediatric patients (>10% difference) included upper respiratory tract infection, rash, activated partial thromboplastin time prolonged, and pyrexia.

In clinical trials one patient developed neutralizing antibodies.

About Gaucher disease

Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside, primarily in macrophages. In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, sp
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SOURCE Shire plc
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