Cerezyme is the ONLY ERT (enzyme replacement therapy) that has
shown long-term efficacy and safety in multiple studies over 20 years
and has been prescribed for over 25 years.1-3
The mean baseline spleen volume was 2369 mL for Cerezyme patients and 2603 mL for alglucerase patients.
The absolute change from baseline was -902 mL for Cerezyme and -874 mL for alglucerase. Difference of absolute change was -28 mL (95% CI: -652, 596).
The mean baseline liver volume was 2521 mL for Cerezyme patients and
2788 mL for alglucerase patients.
The absolute change from baseline was -310 mL for Cerezyme and -307 mL for alglucerase. Difference of absolute change was -3 mL (95% CI: -246, 240).
The mean baseline hemoglobin level was 10.7 g/dL for Cerezyme patients and 10.9 g/dL for alglucerase patients.
The mean baseline platelet count level was 68.5 x 103/mL3 for Cerezyme patients and 74.2 x 103/mL3 for alglucerase patients.
Bone x-rays showed improvements in cortical thickness and lucencies
in 7 of 11 Cerezyme-treated patients
Cerezyme® (imiglucerase) for injection is indicated for treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions:
Warnings and Precautions:
Hypersensitivity and Infusion-Associated Reactions: Hypersensitivity reactions, some of which are serious and include anaphylaxis have been reported. Hypersensitivity and other infusion-associated reactions have been reported during or shortly after infusion and include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, cough, cyanosis, tachycardia, and hypotension. Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions. Not all patients with symptoms of hypersensitivity have detectable IgG antibody. Consider periodic monitoring during the first year of treatment for IgG antibody formation.
If a severe hypersensitivity reaction occurs, discontinue Cerezyme treatment and initiate appropriate medical treatment. Consider the risks and benefits of readministering Cerezyme to individual patients following a severe reaction. If Cerezyme is readministered, consider reducing the rate of infusion, pretreat with antihistamines and/or corticosteroids, and monitor patients for new signs and symptoms of a severe hypersensitivity reaction.
Adverse reactions reported in adults include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting.
Adverse reactions reported in pediatric patients 2 years of age and older are similar to adults.
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.
Please see Full Prescribing Information (PDF).
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Medical Information at 1-800-745-4447, Option 2.