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Comprehensive Assessment
Regardless of clinical presentation and symptoms, all patients should receive an initial comprehensive assessment of all potential disease compartments: anemia, thrombocytopenia, hepatomegaly, splenomegaly, skeletal pathology, growth retardation in pediatric patients, pulmonary involvement, functional health and well-being, and a thorough physical examination. The information obtained should then be used to establish therapeutic goals for all disease compartments. The recommended primary assessments are:
Physical examination
Hematologic (hemoglobin and platelet count)
Biochemical (chitotriosidase, angiotensin-converting enzyme, and/or tartrate-resistant acid phosphatase)
Visceral (liver and spleen volumes)
Skeletal (assessment of bone marrow infiltration, osteonecrosis, and osteopenia)
Patient-reported Quality-of-Life
Important Safety Information
Approximately 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. For more information, consult your physician. To learn more, please see full product information (PDF), or contact Genzyme at 1-800-745-4447.
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