Cerezyme Side Effects Center

Last updated on RxList: 9/20/2022
Cerezyme Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Cerezyme?

Cerezyme (imiglucerase) Injection is a man-made form of the beta-glucocerebrosidase protein 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.

What Are Side Effects of Cerezyme?

Cerezyme may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • dizziness,
  • itching,
  • lightheadedness,
  • sweating,
  • chest pain,
  • cough,
  • flushing (warmth, redness, or tingly feeling),
  • fever,
  • chills,
  • cough with yellow or green mucus,
  • stabbing chest pain,
  • wheezing,
  • shortness of breath, and
  • worsening or no improvement in your Gaucher disease symptoms

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Cerezyme include:

  • injection site reactions (discomfort, burning, itching, swelling, or open wound or sore)
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • fatigue
  • headache
  • dizziness, and
  • rash

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Cerezyme

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.

What Drugs, Substances, or Supplements Interact with Cerezyme?

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.

Cerezyme During Pregnancy or Breastfeeding

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.

Additional Information

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.

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Cerezyme Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or shortly after the injection. Tell your caregiver right away if you feel dizzy, itchy, light-headed, sweaty, or have chest pain, cough, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Call your doctor at once if you have:

  • fever, chills, cough with yellow or green mucus;
  • stabbing chest pain, wheezing, feeling short of breath; or
  • worsening or no improvement in your Gaucher disease symptoms.

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea;
  • fast heartbeats;
  • headache, dizziness;
  • back pain;
  • fever, chills, tired feeling;
  • mild rash; or
  • itching, burning, swelling, or other discomfort around the IV needle.
Cerezyme Professional Information

SIDE EFFECTS

Clinical Trials And Postmarketing Experience

The following adverse reactions associated with the use of imiglucerase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

System Organ Class Adverse Reactions
Nervous system disorders dizziness, headache
Cardiac disorders tachycardia
Vascular disorders cyanosis,* flushing,* hypotension*
Respiratory, thoracic and mediastinal disorders cough,* dyspnea,* pneumonia, pulmonary hypertension
Gastrointestinal disorders abdominal pain, diarrhea, nausea, vomiting
Immune system disorders anaphylaxis,* hypersensitivity
Skin and subcutaneous tissue disorders angioedema,* pruritus,* rash, urticaria*
Musculoskeletal and connective tissue disorders back pain
General disorders and administration site conditions chest discomfort,* chills, fatigue, infusion-site burning, infusion-site discomfort, infusion-site swelling, pyrexia
* Signs and symptoms suggestive of hypersensitivity and other infusion-associated reactions [see WARNINGS AND PRECAUTIONS].

Adverse reactions reported in pediatric patients 2 years of age and older were similar to adults.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other imiglucerase products may be misleading.

Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme during the first year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment and rarely developed antibodies to Cerezyme after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity. Patients with antibody to Cerezyme have higher risk of hypersensitivity reaction [see WARNINGS AND PRECAUTIONS]. Patients who developed IgG antibody to Cerezyme had increased elimination half-life compared to patients without antibody [see CLINICAL PHARMACOLOGY].

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Cerezyme (Imiglucerase)

© Cerezyme Patient Information is supplied by Cerner Multum, Inc. and Cerezyme Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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