Individualized Enzyme Replacement Therapy Dosing

Tailoring of therapy to meet the patient’s individual therapeutic goals requires individualization of dosage. Responses to enzyme replacement therapy (ERT) may vary.

The objective of initial ERT dosing is to enable the patient to achieve therapeutic goals. The initial ERT dose should be based on the patient’s age, the results of the comprehensive initial assessment, the patient’s overall severity and burden of disease, and the findings from regular comprehensive monitoring.

The objective of maintenance dosing is to enable the patient to maintain therapeutic goals. Maintenance dosing should be based on the results of regular comprehensive monitoring.

Dosing Adjustment

Patients must be monitored after initiation of ERT to ensure that therapeutic goals are met. Dosage increases should be considered for patients who do not achieve their therapeutic goals within the expected time frame. Dosage increases should also be considered for patients who do not sustain their therapeutic goals.

Before dosage is reduced for any patient, there must be careful and thorough evaluation of improvement in disease compartments. Go to Administering Cerezyme® (imiglucerase for injection) to learn more.

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.

Cerezyme (imiglucerase for injection). Prescribing information. Genzyme Corp. 2004; http://www.cerezyme.com/global/pi.pdf. Accessed January 14, 2005. er