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

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.

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