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)* |
| High blood pressure (hypertension)* |
| 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.
Cerezyme can cause serious side effects including
Allergic Reactions (Including Anaphylaxis) and Infusion-Associated Reactions (IARs):
Signs of an allergic reaction reported during or shortly after an infusion included itching, flushing, hives, swelling under the skin, chest discomfort, shortness of breath, coughing, a bluish discoloration of the skin due to diminished oxygen, rapid heart rate, and low blood pressure.
Signs of an infusion reaction included rash, chills, fatigue, infusion-site burning, infusion-site discomfort, or infusion-site swelling, fever, and high blood pressure. Tell your healthcare professional right away if you experience any reactions. Your healthcare professional may slow or stop the infusion or may lower the next dose. Your healthcare professional may decide to give you antihistamine, anti-fever, and/or steroid medications before your infusions and monitor you for new signs and symptoms of a reaction.
Immune Responses
Approximately 15% of patients treated and tested to date have developed immune responses (antibodies) to Cerezyme during the first year of therapy. These patients have a higher risk of an allergic reaction. Your healthcare professional may periodically test for the presence of antibodies.
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.