Data from FDA - Curated by EPG Health - Last updated 30 April 2018

Indication(s)

INDICATIONS AND 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

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Advisory information

contraindications
CONTRAINDICATIONS There are no known contraindications to the use of Cerezyme® (imiglucerase for injection). Treatment with Cerezyme should be carefully re-evaluated if there is significant clinical evidence of hypersensitivity to the product.
Special warnings and precautions
PRECAUTIONS General In less than 1% of the patient population, pulmonary hypertension and pneumonia have also been observed during treatment with Cerezyme® (imiglucerase for injection). Pulmonary hypertension and pneumonia are known complications of Gaucher disease and have been observed both in patients receiving and not receiving Cerezyme . No causal relationship with Cerezyme has been established. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension. Therapy with Cerezyme should be directed by physicians knowledgeable in the management of patients with Gaucher disease. Caution may be advisable in administration of Cerezyme to patients previously treated with Ceredase (alglucerase injection) and who have developed antibody to Ceredase or who have exhibited symptoms of hypersensitivity to Ceredase. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been conducted in either animals or humans to assess the potential effects of Cerezyme® (imiglucerase for injection) on carcinogenesis, mutagenesis, or impairment of fertility. Teratogenic Effects Animal reproduction studies have not been conducted with Cerezyme® (imiglucerase for injection). It is also not known whether Cerezyme can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Cerezyme should not be administered during pregnancy except when the indication and need are clear and the potential benefit is judged by the physician to substantially justify the risk. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cerezyme® (imiglucerase for injection) is administered to a nursing woman. Pediatric Use The safety and effectiveness of Cerezyme® (imiglucerase for injection) have been established in patients between 2 and 16 years of age. Use of Cerezyme in this age group is supported by evidence from adequate and well-controlled studies of Cerezyme and Ceredase (alglucerase injection) in adults and pediatric patients, with additional data obtained from the medical literature and from long-term postmarketing experience. Cerezyme has been administered to patients younger than 2 years of age, however the safety and effectiveness in patients younger than 2 have not been established.
Adverse reactions
ADVERSE REACTIONS Since the approval of Cerezyme® (imiglucerase for injection) in May 1994, Genzyme has maintained a worldwide post-marketing database of spontaneously reported adverse events and adverse events discussed in the medical literature. The percentage of events for each reported adverse reaction term has been calculated using the number of patients from these sources as the denominator for total patient exposure to Cerezyme since 1994. Actual patient exposure is difficult to obtain due to the voluntary nature of the database and the continuous accrual and loss of patients over that span of time. The actual number of patients exposed to Cerezyme since 1994 is likely to be greater than estimated from these voluntary sources and, therefore, the percentages calculated for the frequencies of adverse reactions are most likely greater than the actual incidences. Experience in patients treated with Cerezyme has revealed that approximately 13.8% of patients experienced adverse events which were judged to be related to Cerezyme administration and which occurred with an increase in frequency. Some of the adverse events were related to the route of administration. These include discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Each of these events was found to occur in <1% of the total patient population. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of patients. Onset of such symptoms has occurred during or shortly after infusions; these symptoms include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Anaphylactoid reaction has also been reported (see WARNINGS ). Each of these events was found to occur in <1.5% of the total patient population. Pre-treatment with antihistamines and/or corticosteroids and reduced rate of infusion have allowed continued use of Cerezyme in most patients. Additional adverse reactions that have been reported in approximately 6.5% of patients treated with Cerezyme include: nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Each of these events was found to occur in < 1.5% of the total patient population. Incidence rates cannot be calculated from the spontaneously reported adverse events in the post-marketing database. From this database, the most commonly reported adverse events in children (defined as ages 2–12 years) included dyspnea, fever, nausea, flushing, vomiting, and coughing, whereas in adolescents (>12–16 years) and in adults (>16 years) the most commonly reported events included headache, pruritus, and rash. In addition to the adverse reactions that have been observed in patients treated with Cerezyme , transient peripheral edema has been reported for this therapeutic class of drug.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Cerezyme® (imiglucerase for injection) is administered by intravenous infusion over 1-2 hours. Dosage should be individualized to each patient. Initial dosages range from 2.5 U/kg of body weight 3 times a week to 60 U/kg once every 2 weeks. 60 U/kg every 2 weeks is the dosage for which the most data are available. Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration. Dosage adjustments should be made on an individual basis and may increase or decrease, based on achievement of therapeutic goals as assessed by routine comprehensive evaluations of the patient's clinical manifestations. Cerezyme should be stored at 2-8°C (36-46°F). After reconstitution, Cerezyme should be inspected visually before use. Because this is a protein solution, slight flocculation (described as thin translucent fibers) occurs occasionally after dilution. The diluted solution may be filtered through an in-line low protein-binding 0.2 μm filter during administration. Any vials exhibiting opaque particles or discoloration should not be used. DO NOT USE Cerezyme after the expiration date on the vial. On the day of use, after the correct amount of Cerezyme to be administered to the patient has been determined, the appropriate number of vials are each reconstituted with Sterile Water for Injection, USP. The final concentrations and administration volumes are provided in the following table: 200 Unit Vial 400 Unit Vial Sterile water for reconstitution 5.1 mL 10.2 mL Final volume of reconstituted product 5.3 mL 10.6 mL Concentration after reconstitution 40 U/mL 40 U/mL Withdrawal volume 5.0 mL 10.0 mL Units of enzyme within final volume 200 units 400 units A nominal 5.0 mL for the 200 unit vial (10.0 mL for the 400 unit vial) is withdrawn from each vial. The appropriate amount of Cerezyme for each patient is diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100–200 mL. Cerezyme is administered by intravenous infusion over 1-2 hours. Aseptic techniques should be used when diluting the dose. Since Cerezyme does not contain any preservative, after reconstitution, vials should be promptly diluted and not stored for subsequent use. Cerezyme , after reconstitution, has been shown to be stable for up to 12 hours when stored at room temperature (25°C) and at 2-8°C. Cerezyme , when diluted, has been shown to be stable for up to 24 hours when stored at 2-8°C. Relatively low toxicity, combined with the extended time course of response, allows small dosage adjustments to be made occasionally to avoid discarding partially used bottles. Thus, the dosage administered in individual infusions may be slightly increased or decreased to utilize fully each vial as long as the monthly administered dosage remains substantially unaltered.
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cerezyme® (imiglucerase for injection) is administered to a nursing woman.

More information

Category Value
Authorisation number NDA020367
Agency product number Q6U6J48BWY
Orphan designation No
Product NDC 58468-4663,58468-1983
Date Last Revised 10-04-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1726260
Marketing authorisation holder Genzyme Corporation