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Cerezyme

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Cerezyme

Cerezyme

Cerezyme Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cerezyme (imiglucerase) Injection is a man-made form of the beta-glucocerebrosidase protein. It is used to treat those who have a deficiency of beta-glucocerebrosidase (Gaucher disease) that causes anemia, low platelet count, bone disease, enlargement of the liver, or enlargement of the spleen. Common side effects of Cerezyme include discomfort at the site of injection, nausea, abdominal pain, diarrhea, fatigue, headache, dizziness, and rash.

The recommended dosage of Cerezyme is individualized to each patient and ranges from 2.5 U/kg of body weight 3 times per week to 60 U/kg once every 2 weeks. Before taking Cerezyme tell your doctor if you have antibodies to or have had allergic reactions to either imiglucerase or alglucerase (Ceredase). There are no known drug interactions to Cerezyme. You shouldn't take Cerezyme if you are pregnant unless your doctor determines it to be absolutely necessary. Caution should be taken if you are breastfeeding while taking Cerezyme.

Our Cerezyme (imiglucerase) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cerezyme in Detail - Patient Information: Side Effects

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. 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cerezyme (Imiglucerase) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cerezyme Overview - Patient Information: Side Effects

SIDE EFFECTS: Fever, headache, nausea, vomiting, swelling of the hands/feet (edema), or redness/pain/itching/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, flushing, chest pain, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cerezyme (Imiglucerase)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cerezyme FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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® (imiglucerase) 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® (imiglucerase) 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® (imiglucerase) has revealed that approximately 13.8% of patients experienced adverse events which were judged to be related to Cerezyme® (imiglucerase) 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® (imiglucerase) in most patients. Additional adverse reactions that have been reported in approximately 6.5% of patients treated with Cerezyme® (imiglucerase) 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® (imiglucerase) , transient peripheral edema has been reported for this therapeutic class of drug.

Read the entire FDA prescribing information for Cerezyme (Imiglucerase) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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