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
Indication
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:
with over 25 years of real-world
experience1,2with multiple studies showing
long-term outcomes1,3-5as the longest-studied ERT1,6
Efficacy and safety demonstrated in adult and pediatric patients with Gaucher disease type 1
Explore CerezymeCerezyme® (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.