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warnings
WARNINGS Approximately 13% of patients treated clinically and tested to date have developed IgG antibody to Ceredase ® during the first year of therapy. It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Ceredase ® after 12 months of therapy. Approximately 25% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity. Thus, patients with antibody to Ceredase ® have a higher risk of hypersensitivity reaction. Conversely, not all patients with symptoms of hypersensitivity have detectable antibody and further evaluation of their antibody isotypes and mechanisms is continuing. It is suggested that patients be monitored periodically for IgG antibody formation. At present, should a patient experience a reaction with symptoms suggestive of hypersensitivity, it is recommended that a serum sample for tryptase levels and complement activation be drawn within two hours of the event after appropriate treatment of the symptoms. Subsequent serum for testing antibody to Ceredase ® would be helpful. Decreased efficacy has been noted in less than 0.5% of treated patients due to antibodies to Ceredase ® .
ADVERSE REACTIONS Experience in over 1000 patients treated with Ceredase ® has revealed a small number of adverse events. Some of these events were related to the route of administration including discomfort, pruritus, burning and swelling or sterile abscess at the site of venipuncture. The remaining experiences consisted of slight fever, chills, abdominal discomfort, nausea or vomiting. None of these events were judged to require medical intervention. Symptoms suggestive of hypersensitivity have been noted in a limited number of patients. Onset of such symptoms has occurred during or shortly after infusions; these symptoms have included pruritus, flushing, urticaria/angioedema (a small number of patients have had upper airway involvement), chest discomfort, respiratory symptoms, nausea and abdominal cramping. Hypotension has been reported to occur during a few of these events (see WARNINGS ). Pretreatment with antihistamines and reduced rate of infusion has allowed continued use of Ceredase ® in most patients. Additional adverse symptoms which have been reported include: fatigue, vasomotor irritability or hot flash, weakness, headache, light headedness, dysosmia, oral ulcerations, backache and transient peripheral edema, and diarrhea. Menstrual abnormalities and false positive pregnancy tests have previously been reported, but due to the introduction of manufacturing steps designed to reduce the level of hCG in Ceredase ® , the likelihood of these occurrences is reduced.