Cerezyme Side Effects

Generic name: imiglucerase

Note: This document contains side effect information about imiglucerase. Some of the dosage forms listed on this page may not apply to the brand name Cerezyme.

Some side effects of Cerezyme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to imiglucerase: intravenous powder for injection

Symptoms of allergic reactions including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; hives; itching; flushing; and dizziness or fainting, have occurred with the use of imiglucerase (the active ingredient contained in Cerezyme) Approximately 15% of patients treated with imiglucerase develop antibodies to imiglucerase. Approximately 46% of patients with detectable antibodies have experienced an allergic reaction. Emergency medical attention may be required if an allergic reaction is experienced.

Talk to your doctor if you experience any of the following less serious side effects:

• discomfort, burning, itching, swelling, or abscess (open wound or sore) at the injection site;

• nausea or vomiting;

• abdominal pain;

• diarrhea;

• fatigue;

• headache;

• dizziness; or

• rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to imiglucerase: intravenous powder for injection

Hypersensitivity

Hypersensitivity side effects including symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of patients. Anaphylactoid reaction has also been reported.

Onset of hypersensitivity symptoms has occurred during or shortly after infusions. These symptoms include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Each of these events was found to occur in less than 1.5% of the total patient population. Pretreatment with antihistamines and/or corticosteroids and reduced rate of infusion have allowed continued use of imiglucerase in most patients.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and diarrhea have been reported have been reported in less than 1.5% of the total patient population.

General

General side effects including fatigue, headache, abdominal pain, fever, dizziness, chills, and backache have been reported in less than 1.5% of the total patient population.

Local

Local side effects including discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Each of these events was found to occur in less than 1% of the total patient population.

Cardiovascular

Cardiovascular side effects including tachycardia (less than 1.5%) have been reported. In addition to the adverse reactions that have been reported in patients treated with imiglucerase (the active ingredient contained in Cerezyme) transient peripheral edema has been reported for this therapeutic class of drug.

Dermatologic

Dermatologic side effects including rash (less than 1.5%) have been reported.

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