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Galsulfase Approved in Brazil for the Treatment of Mucopolysaccharidosis VI NEW YORK -- February 3, 2009 -- Brazil's National Health Surveillance Agency (ANVISA) has approved galsulfase (Naglazyme) for the treatment of patients with mucopolysaccharidosis VI. The most common adverse events observed in clinical trials in patients treated with galsulfase were headache, fever, arthralgia, vomiting, upper respiratory infections, abdominal pain, diarrhoea, ear pain, cough, and otitis media. Severe reactions included angioneurotic oedema, hypotension, dyspnoea, bronchospasm, respiratory distress, apnoea, and urticaria. The most common symptoms of infusion reactions included fever, chills/rigors, headache, rash, and mild to moderate urticaria. Nausea, vomiting, elevated blood pressure, retrosternal pain, abdominal pain, malaise, and joint pain were also reported. No patients discontinued for adverse events. Nearly all patients developed antibodies as a result of treatment, but the level of the immune response did not correlate with the severity of adverse events. Because antihistamine use may increase the risk of apnoeic episodes, evaluation of airway patency should be considered prior to the initiation of treatment. Consideration to delay galsulfase infusion should be given when treating patients who present with an acute febrile or respiratory illness. SOURCE: BioMarin Pharmaceutical Inc. E-mail this page to a friend or colleague! To print, use this version