Cerezyme® (Imiglucerase)

Cerezyme®

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Important Safety Information

Cerezyme (imiglucerase) is an enzyme replacement therapy (ERT) for pediatric and adult patients with Type 1 Gaucher disease. It is recommended for individuals whose condition has resulted in anemia, bone disease, low blood platelet count, and/or an enlarged liver or spleen.

Approximately 15% of patients develop antibodies to Cerezyme within their first year of infusion therapy. This makes it more likely to experience an allergic reaction. For this reason, your doctor should conduct periodic tests for the presence of antibodies. Tell your doctor immediately if you experience itching, swelling, hives, chest discomfort, shortness of breath, coughing, low blood pressure, or bluish discoloration of the skin.

What is the most important information I should know about Cerezyme?

Gaucher disease is a rare condition caused by gene mutations. These mutations lead to a buildup of glucosylceramide (GL-1) on vital organs — specifically the spleen and liver — as well as the bones. As a result, patients experience breathing difficulties, muscle dysfunction, and seizures.

Cerezyme works by breaking down GL-1 — thus preventing that damaging buildup. Cerezyme also relieves pain and prevents bone loss.

Side Effects of Cerezyme

As with any prescription medication, Cerezyme carries a risk of side effects. Although rare, they can cause extensive discomfort, including:

  • Fever
  • Abdominal pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Fatigue
  • Headaches
  • Rash
  • Dizziness
  • Rapid heart rate
  • Chills
  • Backache
  • Temporary swelling of the legs

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

Cerezyme is administered through intravenous infusion. The dosage and frequency will depend on the patient’s weight and the severity of Gaucher disease. The most common schedule takes place bi-weekly and is usually about 60 units per kg of body weight.

Please refer to the full prescribing information.