Cerezyme therapy is given by intravenous (IV) infusion. This is a process that involves injecting the drug into a vein, directly into the bloodstream. Like other protein-based medications, Cerezyme cannot be taken orally as a pill or liquid because proteins are destroyed in the digestive system. Infusion into the blood stream bypasses your body’s digestive processes.
Your doctor will determine your Cerezyme dose and frequency. Dose should be individualized to each patient and is based on patient weight and disease severity.
Infusions may last anywhere from one to two hours and can be done in a variety of settings, such as a doctor’s office, a treatment center, or in some cases, home.
During your infusion, you can do things like read a book, talk on the phone, listen to music, visit with friends or family members who are with you — even take a nap if you wish.
Infusion Site Reactions
15% of patients have developed immune responses (antibodies). These
patients have a higher risk of an allergic reaction (hypersensitivity).
Use Cerezyme® (imiglucerase for injection) carefully if you have had an
allergic reaction to the product in the past. Symptoms suggestive of
allergic reaction happened in 6.6% of patients, and include
anaphylactoid reaction (a serious allergic reaction), itching,
flushing, hives, an accumulation of fluid under the skin, chest
discomfort, shortness of breath, coughing, cyanosis (a bluish
discoloration of the skin due to diminished oxygen), and low blood
pressure. Side effects related to Cerezyme administration have been
reported in less than 15% of patients. Each of the following events
occurred in less than 2% of the total patient population. Reported side
effects include nausea, vomiting, abdominal pain, diarrhea, rash,
fatigue, headache, fever, dizziness, chills, backache, and rapid heart
rate. Because Cerezyme therapy is administered by intravenous infusion,
reactions at the site of injection may occur: discomfort, itching,
burning, swelling or uninfected abscess. Cerezyme is available by
prescription only. Patients should notify their physician immediately
if they experience any side effects while undergoing treatment with
Cerezyme. For more information, consult your physician. To learn more,
please see full product information; contact Genzyme at 1-800-745-4447.
Indication & Usage
Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:
- anemia (low red blood cell count)
- thrombocytopenia (low blood platelet count)
- bone disease
- hepatomegaly or splenomegaly (enlarged liver or spleen)
Important Safety Information
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. Serious allergic reactions (anaphylaxis) have been reported in less than 1% of patients. Symptoms suggestive of allergic reaction happened in approximately 7% of patients, and include itching, flushing, hives, swelling, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), and low blood pressure. If you have had an allergic reaction to Cerezyme, you and your doctor should use caution if you continue to receive treatment with Cerezyme.
High blood pressure in the arteries of the lungs (pulmonary hypertension) and pneumonia have been observed in less than 1% of patients during treatment with Cerezyme. These are also known complications of Gaucher disease regardless of treatment. If you experience symptoms such as shortness of breath or chest pain, with or without fever, contact your doctor.
Approximately 14% of patients have experienced side effects related to treatment with Cerezyme. Some of these reactions occur at the site of injection such as discomfort, itching, burning, swelling or uninfected abscess. Other side effects, each of which was reported by less than 2% of patients, include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and rapid heart rate. Temporary swelling in the legs has also been observed with drugs like Cerezyme.
Please see Full Prescribing Information (PDF).