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Cerezyme
Overview
What is Cerezyme?
Cerezyme
Cerezyme
Cerezyme
An enzyme unit (U) is defined as the amount of enzyme that catalyzes the hydrolysis of 1 micromole of the synthetic substrate para-nitrophenyl-β-D-glucopyranoside (pNP-Glc) per minute at 37°C. The product is stored at 2-8°C (36-46°F). After reconstitution with Sterile Water for Injection, USP, the imiglucerase concentration is 40 U/mL (see for final concentrations and volumes). Reconstituted solutions have a pH of approximately 6.1.
What does Cerezyme look like?
What are the available doses of Cerezyme?
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What should I talk to my health care provider before I take Cerezyme?
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How should I use Cerezyme?
Cerezyme
Cerezyme
On the day of use, after the correct amount of 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:
A nominal 5.0 mL for the 200 unit vial (10.0 mL for the 400 unit vial) is withdrawn from each vial.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 for each patient is diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100–200 mL. is administered by intravenous infusion over 1-2 hours. Aseptic techniques should be used when diluting the dose. Since does not contain any preservative, after reconstitution, vials should be promptly diluted and not stored for subsequent use., 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. , 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.
What interacts with Cerezyme?
There are no known contraindications to the use of (imiglucerase for injection). Treatment with should be carefully re-evaluated if there is significant clinical evidence of hypersensitivity to the product.
What are the warnings of Cerezyme?
Lithium generally should not be given with diuretics (see ).
Approximately 15% of patients treated and tested to date have developed IgG antibody to (imiglucerase for injection) during the first year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment and rarely developed antibodies to after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity.
Patients with antibody to have a higher risk of hypersensitivity reaction. Conversely, not all patients with symptoms of hypersensitivity have detectable IgG antibody. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.
Treatment with should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the product.
Anaphylactoid reaction has been reported in less than 1% of the patient population. Further treatment with imiglucerase should be conducted with caution. Most patients have successfully continued therapy after a reduction in rate of infusion and pretreatment with antihistamines and/or corticosteroids.
What are the precautions of Cerezyme?
General
In less than 1% of the patient population, pulmonary hypertension and pneumonia have also been observed during treatment with (imiglucerase for injection). Pulmonary hypertension and pneumonia are known complications of Gaucher disease and have been observed both in patients receiving and not receiving . No causal relationship with has been established. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.
Therapy with should be directed by physicians knowledgeable in the management of patients with Gaucher disease.
Caution may be advisable in administration of 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 (imiglucerase for injection) on carcinogenesis, mutagenesis, or impairment of fertility.
Teratogenic Effects
Animal reproduction studies have not been conducted with (imiglucerase for injection). It is also not known whether can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. 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 (imiglucerase for injection) is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of (imiglucerase for injection) have been established in patients between 2 and 16 years of age. Use of in this age group is supported by evidence from adequate and well-controlled studies of and Ceredase (alglucerase injection) in adults and pediatric patients, with additional data obtained from the medical literature and from long-term postmarketing experience. 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.
What are the side effects of Cerezyme?
Since the approval of (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 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 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 has revealed that approximately 13.8% of patients experienced adverse events which were judged to be related to 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 ). 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 in most patients.
Additional adverse reactions that have been reported in approximately 6.5% of patients treated with 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 , transient peripheral edema has been reported for this therapeutic class of drug.
What should I look out for while using Cerezyme?
There are no known contraindications to the use of (imiglucerase for injection). Treatment with should be carefully re-evaluated if there is significant clinical evidence of hypersensitivity to the product.
Approximately 15% of patients treated and tested to date have developed IgG antibody to (imiglucerase for injection) during the first year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment and rarely developed antibodies to after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity.
Patients with antibody to have a higher risk of hypersensitivity reaction. Conversely, not all patients with symptoms of hypersensitivity have detectable IgG antibody. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.
Treatment with should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the product.
Anaphylactoid reaction has been reported in less than 1% of the patient population. Further treatment with imiglucerase should be conducted with caution. Most patients have successfully continued therapy after a reduction in rate of infusion and pretreatment with antihistamines and/or corticosteroids.
What might happen if I take too much Cerezyme?
Experience with doses up to 240 U/kg every 2 weeks have been reported. At that dose there have been no reports of obvious toxicity.
How should I store and handle Cerezyme?
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Cerezyme 200 Units per Vial NDC 58468-1983-1 400 Units per Vial NDC 58468-4663-1 Store at 2-8°C (36-46°F). Rx only Genzyme CorporationCambridge, MA 02142 USAU.S. Patent Numbers: 5,236,838; 5,549,892Revised: April 2018 Cerezyme 200 Units per Vial NDC 58468-1983-1 400 Units per Vial NDC 58468-4663-1 Store at 2-8°C (36-46°F). Rx only Genzyme CorporationCambridge, MA 02142 USAU.S. Patent Numbers: 5,236,838; 5,549,892Revised: April 2018 Cerezyme 200 Units per Vial NDC 58468-1983-1 400 Units per Vial NDC 58468-4663-1 Store at 2-8°C (36-46°F). Rx only Genzyme CorporationCambridge, MA 02142 USAU.S. Patent Numbers: 5,236,838; 5,549,892Revised: April 2018 Cerezyme 200 Units per Vial NDC 58468-1983-1 400 Units per Vial NDC 58468-4663-1 Store at 2-8°C (36-46°F). Rx only Genzyme CorporationCambridge, MA 02142 USAU.S. Patent Numbers: 5,236,838; 5,549,892Revised: April 2018 Cerezyme 200 Units per Vial NDC 58468-1983-1 400 Units per Vial NDC 58468-4663-1 Store at 2-8°C (36-46°F). Rx only Genzyme CorporationCambridge, MA 02142 USAU.S. Patent Numbers: 5,236,838; 5,549,892Revised: April 2018 Cerezyme 200 Units per Vial NDC 58468-1983-1 400 Units per Vial NDC 58468-4663-1 Store at 2-8°C (36-46°F). Rx only Genzyme CorporationCambridge, MA 02142 USAU.S. Patent Numbers: 5,236,838; 5,549,892Revised: April 2018 Cerezyme 200 Units per Vial NDC 58468-1983-1 400 Units per Vial NDC 58468-4663-1 Store at 2-8°C (36-46°F). Rx only Genzyme CorporationCambridge, MA 02142 USAU.S. Patent Numbers: 5,236,838; 5,549,892Revised: April 2018
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Gaucher disease is characterized by a deficiency of β-glucocerebrosidase activity, resulting in accumulation of glucocerebroside in tissue macrophages which become engorged and are typically found in the liver, spleen, and bone marrow and occasionally in lung, kidney, and intestine. Secondary hematologic sequelae include severe anemia and thrombocytopenia in addition to the characteristic progressive hepatosplenomegaly, skeletal complications, including osteonecrosis and osteopenia with secondary pathological fractures. (imiglucerase for injection) catalyzes the hydrolysis of glucocerebroside to glucose and ceramide. In clinical trials, improved anemia and thrombocytopenia, reduced spleen and liver size, and decreased cachexia to a degree similar to that observed with Ceredase (alglucerase injection).
Non-Clinical Toxicology
There are no known contraindications to the use of (imiglucerase for injection). Treatment with should be carefully re-evaluated if there is significant clinical evidence of hypersensitivity to the product.Approximately 15% of patients treated and tested to date have developed IgG antibody to (imiglucerase for injection) during the first year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment and rarely developed antibodies to after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity.
Patients with antibody to have a higher risk of hypersensitivity reaction. Conversely, not all patients with symptoms of hypersensitivity have detectable IgG antibody. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.
Treatment with should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the product.
Anaphylactoid reaction has been reported in less than 1% of the patient population. Further treatment with imiglucerase should be conducted with caution. Most patients have successfully continued therapy after a reduction in rate of infusion and pretreatment with antihistamines and/or corticosteroids.
In less than 1% of the patient population, pulmonary hypertension and pneumonia have also been observed during treatment with (imiglucerase for injection). Pulmonary hypertension and pneumonia are known complications of Gaucher disease and have been observed both in patients receiving and not receiving . No causal relationship with has been established. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.
Therapy with should be directed by physicians knowledgeable in the management of patients with Gaucher disease.
Caution may be advisable in administration of to patients previously treated with Ceredase (alglucerase injection) and who have developed antibody to Ceredase or who have exhibited symptoms of hypersensitivity to Ceredase.
Since the approval of (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 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 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 has revealed that approximately 13.8% of patients experienced adverse events which were judged to be related to 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 ). 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 in most patients.
Additional adverse reactions that have been reported in approximately 6.5% of patients treated with 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 , transient peripheral edema has been reported for this therapeutic class of drug.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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