Since the approval of Cerezyme® (imiglucerase for injection) in May 1994, Genzyme has maintained a
worldwide post-marketing database of spontaneously reported adverse events and adverse events
discussed in the medical literature. The percentage of events for each reported adverse reaction term
has been calculated using the number of patients from these sources as the denominator for total patient
exposure to Cerezyme since 1994. Actual patient exposure is difficult to obtain due to the voluntary
nature of the database and the continuous accrual and loss of patients over that span of time. The actual
number of patients exposed to Cerezyme since 1994 is likely to be greater than estimated from these
voluntary sources and, therefore, the percentages calculated for the frequencies of adverse reactions
are most likely greater than the actual incidences.
Experience in patients treated with Cerezyme® has revealed that approximately 13.8% of patients
experienced adverse events which were judged to be related to Cerezyme administration and which
occurred with an increase in frequency. Some of the adverse events were related to the route of
administration. These include discomfort, pruritus, burning, swelling or sterile abscess at the site of
venipuncture. Each of these events was found to occur in < 1% of the total patient population.
Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of patients. Onset of
such symptoms has occurred during or shortly after infusions; these symptoms include pruritus,
flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension.
Anaphylactoid reaction has also been reported (see WARNINGS). Each of these events was found to
occur in < 1.5% of the total patient population. Pre-treatment with antihistamines and/or corticosteroids
and reduced rate of infusion have allowed continued use of Cerezyme in most patients.
Additional adverse reactions that have been reported in approximately 6.5% of patients treated with
Cerezyme include: nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness,
chills, backache, and tachycardia. Each of these events was found to occur in < 1.5% of the total patient
Incidence rates cannot be calculated from the spontaneously reported adverse events in the postmarketing
database. From this database, the most commonly reported adverse events in children (defined
as ages 2 – 12 years) included dyspnea, fever, nausea, flushing, vomiting, and coughing, whereas in
adolescents (>12 – 16 years) and in adults (>16 years) the most commonly reported events included
headache, pruritis, and rash.
In addition to the adverse reactions that have been observed in patients treated with Cerezyme, transient
peripheral edema has been reported for this therapeutic class of drug.
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