Clinical Studies
Genzyme is committed to advancing treatment for Gaucher disease and other rare genetic disorders. The company offers the first specific therapies for Type 1 Gaucher disease.
Genzyme’s ongoing clinical studies and the Genzyme-supported Gaucher Registry help doctors and researchers understand how Gaucher disease and Cerezyme treatment affect different people over long periods of time. These ongoing studies help researchers answer questions such as how to optimize treatment.
In addition to these clinical studies, Genzyme has ongoing research initiatives to develop new approaches to the treatment of Type 1 Gaucher disease.
For information on current clinical trials supported by Genzyme and others, please visit clinicaltrials.gov and search for trials related to Type 1 Gaucher disease. For information on the Gaucher Registry, please visit gaucherregistry.com.
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:
- anemia (low red blood cell count)
- thrombocytopenia (low blood platelet count)
- bone disease
- hepatomegaly or splenomegaly (enlarged liver or spleen)
Important Safety Information
Approximately 15% of patients have developed immune responses (antibodies). These patients have a higher risk of an allergic reaction (hypersensitivity). Use Cerezyme® (imiglucerase for injection) carefully if you have had an allergic reaction to the product in the past. Symptoms suggestive of allergic reaction happened in 6.6% of patients, and include anaphylactoid reaction (a serious allergic reaction), itching, flushing, hives, an accumulation of fluid under the skin, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), and low blood pressure.
Side effects related to Cerezyme administration have been reported in less than 15% of patients. Each of the following events occurred in less than 2% of the total patient population. Reported side effects include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and rapid heart rate. Because Cerezyme therapy is administered by intravenous infusion, reactions at the site of injection may occur: discomfort, itching, burning, swelling or uninfected abscess. Cerezyme is available by prescription only. For more information, consult your physician.
Please see Full Prescribing Information (PDF).