Cerezyme is the ONLY ERT (enzyme replacement therapy) that has
shown long-term efficacy and safety in multiple studies over 10 years
and has been prescribed for over 20 years.1,3
The 10-year ICGG Gaucher Registry study by Weinreb et al is a retrospective, observational, single-arm study of patients with Gaucher disease type 1 who had dose and clinical data at first infusion of Cerezyme* and after 10 years of therapy. Read more...
The 10-year ICGG Gaucher Registry study by Weinreb et al is a retrospective, observational, single-arm study of patients with Gaucher disease type 1 who had dose and clinical data at first infusion of Cerezyme* and after 10 years of therapy.
Within the study cohort (n=757), subsets of patients were identified with clinical data at treatment initiation and after up to 10 years of follow-up for:
Bone pain was defined as being present if the patient reported this event as occurring in the 30-day interval before the medical visit
*The Cerezyme treatment group from the Gaucher Registry analyses represents patients who received either alglucerase or imiglucerase
Data for the nonsplenectomized patient group are shown above.
*In a retrospective, observational, single-arm study of patients with Gaucher disease type 1 who had bone and clinical data at first infusion of Cerezyme and after 10 years of therapy. The Cerezyme treatment group from the Gaucher Registry analyses represents patients who received either alglucerase or imiglucerase.
†Percentage changes from baseline were calculated by dividing the change from baseline by the baseline value and multiplying by 100.
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:
Approximately 15% of patients have developed IgG antibodies to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.
Hypersensitivity has also been observed in patients without detectable IgG antibodies. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of all patients, and anaphylactoid reactions in less than 1%. Treatment with Cerezyme should be approached with caution in patients who have exhibited hypersensitivity symptoms such as pruritus, flushing, urticarial, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Pre-treatment with antihistamines and/or corticosteroids and a reduced rate of infusion may allow continued treatment in most patients.
In less than 1% of patients, pulmonary hypertension and pneumonia have been observed during treatment with Cerezyme. These are known complications of Gaucher disease regardless of treatment. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.
Approximately 13.8% of patients have experienced adverse events related to treatment with Cerezyme. Some of these are injection site reactions such as discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Additional adverse reactions that have been reported include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Transient peripheral edema has also been reported for this therapeutic class of drug.
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Genzyme Medical Information at 1-800-745-4447, Option 2.
Please see Full Prescribing Information (PDF).