Dosing Preparation and Administration
Individualized Cerezyme Dosing
Tailoring therapy to meet a patient’s individual therapeutic goals requires individualization of dosage. Responses to Cerezyme may vary. Any change in dosages should be determined by the healthcare provider.
Initial dosing
The initial Cerezyme dose should be individualized 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. Initial dosages range from 2.5 units/kg of body weight 3 times a week to 60 units/kg once every 2 weeks. Based on progress related to therapeutic goals, physicians may choose to modify the dose based on individual patient needs.
Maintenance dosing
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 Cerezyme treatment 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. Go to Therapeutic Goals for more information.
Before dosage is reduced for any patient, there must be careful and thorough evaluation of improvement in disease compartments.
Preparation and Administration
To review the steps required to prepare and administer Cerezyme, you can view the Cerezyme Reconstitution and Administration (R&A) guide and video here, or request copies. Download a PDF copy of the Reconstitution & Administration Guide. Go to Request Materials to order the printed guide and video.
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
- thrombocytopenia
- bone disease
- hepatomegaly or splenomegaly
Important Safety Information
Approximately 15% of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6% of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension.
Reactions 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 adverse events include nausea, abdominal pain, vomiting, 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 at the site of injection.
To report suspected adverse reactions, contact Genzyme at 800-745-4447, option 2 or FDA at 800-FDA-1088 or http://www.fda.gov/Safety/MedWatch
Please see Full Prescribing Information (PDF).