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.
The following adverse reactions associated with the use of Cerezyme were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a cause-and-effect relationship to drug exposure.
There may be possible side effects with Cerezyme.
| In adults |
|---|
| Dizziness |
| Headache |
| Rapid heart rate |
| A bluish discoloration of skin due to diminished oxygen (cyanosis)* |
| Flushing* |
| Low blood pressure (hypotension)* |
| Cough* |
| Difficulty breathing* |
| Pneumonia |
| High blood pressure in the lungs (pulmonary hypertension) |
| Stomach pain |
| Diarrhea |
| Nausea |
| Vomiting |
| Serious allergic reaction (anaphylaxis)* |
| Hypersensitivity |
| Accumulation of fluid under the skin (angiodema)* |
| Itching* |
| Rash |
| Hives* |
| Back pain |
| Chest discomfort* |
| Chills |
| Fatigue |
| Infusion-site burning |
| Infusion-site discomfort |
| Infusion-site swelling |
| Fever |
*Signs and symptoms suggestive of allergic reaction (hypersensitivity) and other infusion-associated reactions.
Allergic reaction (hypersensitivity) and infusion-associated reactions
Serious allergic reactions (anaphylaxis) have been reported in patients treated with Cerezyme. Symptoms suggestive of an allergic reaction have been reported during or shortly after an infusion and include itching, flushing, hives, swelling, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), rapid heart rate, and low blood pressure. Inform your doctor and seek medical care if you experience any of these symptoms. If you have had an allergic reaction to Cerezyme, you and your doctor should use caution if you continue to receive treatment with Cerezyme.
Tell your doctor right away if you experience any of these.
Notify your doctor immediately if you experience any side effects while undergoing treatment with Cerezyme
Immune Responses
Approximately 15% of patients have developed immune responses (antibodies) to Cerezyme during the first year of therapy. These patients have a higher risk of an allergic reaction (hypersensitivity). Your doctor may periodically test for the presence of antibodies.
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.
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:
Hypersensitivity and Infusion-Associated Reactions: Serious allergic reactions (anaphylaxis) have been reported in patients treated with Cerezyme. Symptoms suggestive of an allergic reaction have been reported during or shortly after an infusion and include itching, flushing, hives, swelling, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), rapid heart rate, and low blood pressure. Inform your doctor and seek medical care if you experience any of these symptoms. If you have had an allergic reaction to Cerezyme, you and your doctor should use caution if you continue to receive treatment with Cerezyme.
Immune Responses: Approximately 15% of patients have developed immune responses (antibodies) to Cerezyme during the first year of therapy. These patients have a higher risk of an allergic reaction (hypersensitivity). Your doctor may periodically test for the presence of antibodies.
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.
Please see the Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Medical Information at 1-800-745-4447, Option 2.