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
Cerezyme was proven to be safe and effective in 2 prospective clinical trials and was evaluated in multiple studies from the International Collaborative Gaucher Group (ICGG) Gaucher Registry. The long-term safety of Cerezyme was shown in an international monitoring database.3-7
Explore the findings of 6 studies evaluating the safety and efficacy of Cerezyme in visceral, hematologic, and certain bone parameters in adult and pediatric populations with Gaucher disease type 1.1,3-7
Visceral & Hematologic Data |
Bone Data | Pediatric Data |
---|---|---|
Parameters assessed: visceral and hematologic parameters |
48-Month, Long-term Prospective Study4 Parameters assessed: bone mineral density (BMD) and bone crises |
8-Year, Long-term Registry Study7* Parameters assessed: visceral, hematologic and bone parameters |
20-Year, Long-term Registry Study3* Parameters assessed: visceral, hematologic, and bone parameters |
4-year, Long-term Registry Study6 Parameters assessed: bone pain and bone crises |
|
8-Year, Long-term Registry Study5 Parameters assessed: BMD |
Visceral & Hematologic Data |
---|
Parameters assessed: visceral and hematologic parameters |
20-Year, Long-term Registry Study3* Parameters assessed: visceral, hematologic, and bone parameters |
Bone Data |
---|
48-Month, Long-term Prospective Study4 Parameters assessed: bone mineral density (BMD) and bone crises |
4-year, Long-term Registry Study6 Parameters assessed: bone pain and bone crises |
8-Year, Long-term Registry Study5 Parameters assessed: BMD |
Pediatric Data |
---|
8-Year, Long-term Registry Study7* Parameters assessed: visceral, hematologic and bone parameters |
The ICGG Gaucher Registry is the world’s largest cooperative, observational database on Gaucher disease. The ICGG Gaucher Registry is sponsored by Sanofi and directed by the ICGG, a group of physicians who are experts in the management of Gaucher disease.8
Supported by 10-year safety data from an international monitoring database
Review safetyCerezyme® (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:
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.
Immunogenicity:
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.