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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
Adverse reactions related to Cerezyme® (imiglucerase for injection) 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 adverse events include nausea, vomiting, abdominal pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Symptoms suggestive of hypersensitivity include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension. Approximately 15% of patients have developed IgG antibodies; periodic monitoring is suggested. Side effects should be reported promptly to Genzyme Medical Information at 800-745-4447, option 2. To learn more, please see full product information (PDF), or contact Genzyme at 1-800-745-4447.
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