Importance of Staying on Treatment

Since people with Type 1 Gaucher disease do not produce enough of the glucocerebrosidase enzyme on their own, their bodies need a regular supply of the replacement enzyme. That means Cerezyme is a long-term part of treatment for Type 1 Gaucher disease. Regular infusions help ensure that the body has an ongoing supply of enzyme to reduce the glucocerebroside build-up in cells.

If your infusions need to occur during work hours, or if your child’s infusions need to occur during school hours, you may decide to inform employers, teachers and others about the importance of regular infusions. This is an important decision and you may want to talk with your healthcare provider about it.

If you miss an infusion, talk to your doctor about rescheduling your appointment. It may be necessary for you to plan ahead if you will be moving or traveling, so that you don’t miss an infusion. Talk with your doctor or contact Sanofi Genzyme Support Services about the potential for arranging for treatment at your destination.

If you are on Cerezyme treatment and are pregnant or thinking of becoming pregnant, be sure to talk to your doctor. There may be risks associated with staying on Cerezyme therapy during pregnancy. Be sure to tell your doctor if you are breast feeding.

Indication & Usage

Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

  1. anemia (low red blood cell count)
  2. thrombocytopenia (low blood platelet count)
  3. bone disease
  4. hepatomegaly or splenomegaly (enlarged liver or spleen)

Important Safety Information

Approximately 15% of patients have developed immune responses (antibodies) to Cerezyme during the first year of therapy. These patients have a higher risk of an allergic reaction (hypersensitivity). Your doctor may periodically test for the presence of antibodies. Serious allergic reactions (anaphylaxis) have been reported in less than 1% of patients. Symptoms suggestive of allergic reaction happened in approximately 7% of patients, and include itching, flushing, hives, swelling, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), and low blood pressure. If you have had an allergic reaction to Cerezyme, you and your doctor should use caution if you continue to receive treatment with Cerezyme.

High blood pressure in the arteries of the lungs (pulmonary hypertension) and pneumonia have been observed in less than 1% of patients during treatment with Cerezyme. These are also known complications of Gaucher disease regardless of treatment. If you experience symptoms such as shortness of breath or chest pain, with or without fever, contact your doctor.

Approximately 14% of patients have experienced side effects related to treatment with Cerezyme. Some of these reactions occur at the site of injection such as discomfort, itching, burning, swelling or uninfected abscess. Other side effects, each of which was reported by less than 2% of patients, include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and rapid heart rate. Temporary swelling in the legs has also been observed with drugs like Cerezyme.

Please see Full Prescribing Information (PDF).

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

Reference 1. Data on file. Genzyme Corporation; Cambridge, MA.