VPRIV is for patients who are treatment-naïve as well as patients who have previously been treated with imiglucerase.
Replagal Important Safety Information
The most serious adverse reactions seen with Replagal were hypersensitivity reactions. Infusion-related reactions were the most commonly observed adverse reactions in patients treated with Replagal in clinical studies. Most side effects are mild to moderate and include headache, tingling, numbness, tremors, fatigue, change in temperature sensation, increased blood pressure, upset stomach, diarrhea, coughing, sore throat, difficulty sleeping, change in the taste of food, change in smell, difficulty speaking, acne, dry skin and eye problems. About 1 out of 10 patients may have a reaction during or shortly after infusion of Replagal. These effects include chills and facial flushing (warmth and redness).
As with all therapeutic proteins, there is a potential for immunogenicity. IgG antibodies appeared to develop following approximately 3 to 12 months of treatment. After 12 to 54 months of therapy, 17% of Replagal treated patients were antibody positive whereas 7% showed evidence for the development of immunologic tolerance, based on the disappearance of IgG antibodies over time. No IgE antibodies have been detected in any patient receiving Replagal.
Replagal is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information.
|SOURCE Shire plc|
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