Cerezyme Side Effects

Generic Name: imiglucerase

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

Side Effects of Cerezyme - for the Consumer

Cerezyme

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cerezyme:

Backache; chills; diarrhea; dizziness; fever; general body discomfort; headache; nausea; rash; stomach pain; swelling of the legs and feet; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bluish skin discoloration; fast heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Cerezyme Side Effects - for the Professional

Cerezyme

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 toCerezyme® 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 toCerezyme® 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. 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 population.

Incidence rates cannot be calculated from the spontaneously reported adverse events in the post-marketing 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.

Side Effects by Body System - for Healthcare Professionals

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, 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.