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Drug overview for CEREZYME (imiglucerase):
Generic name: IMIGLUCERASE (im-eh-GLUE-ser-aze)
Drug class: Metabolic Disease Enzyme Replacement, Gaucher's Disease
Therapeutic class: Metabolic Disease Enzyme Replacement Agents
Imiglucerase is a biosynthetic (recombinant DNA origin) form of human beta-glucocerebrosidase (glucosylceramidase), a lysosomal enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.
No enhanced Uses information available for this drug.
Generic name: IMIGLUCERASE (im-eh-GLUE-ser-aze)
Drug class: Metabolic Disease Enzyme Replacement, Gaucher's Disease
Therapeutic class: Metabolic Disease Enzyme Replacement Agents
Imiglucerase is a biosynthetic (recombinant DNA origin) form of human beta-glucocerebrosidase (glucosylceramidase), a lysosomal enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for CEREZYME (imiglucerase) have been approved by the FDA:
Indications:
Gaucher's disease
Professional Synonyms:
Cerebroside lipidosis
Familial splenic anemia
Type 1 Gaucher disease
Indications:
Gaucher's disease
Professional Synonyms:
Cerebroside lipidosis
Familial splenic anemia
Type 1 Gaucher disease
The following dosing information is available for CEREZYME (imiglucerase):
The dosage and/or frequency of imiglucerase administration should be individualized and may increase or decrease according to disease severity and patient response and convenience. The manufacturer states that because toxicity of the drug is relatively low and therapeutic response is gradual, an individual dose of imiglucerase occasionally may be increased or decreased slightly to avoid wasting a partially used vial, as long as the total monthly dosage is not altered substantially.
Initial dosages of imiglucerase in children and adolescents (2-16 years of age) and adults with Gaucher disease range from 2.5 units/kg 3 times weekly to 60 units/kg every 2 weeks. An imiglucerase dosage of 60 units/kg every 2 weeks is the dosage for which most clinical data are available, but initial disease severity may dictate a relatively high dosage or more frequent administration.
While clinical improvement in hematologic and visceral manifestations generally occurs within the first year of enzyme replacement therapy, response to skeletal manifestations may require 2-3 years of therapy. Some clinicians state that failure to respond within 6 months indicates the need for a higher dosage of imiglucerase.
Initial dosages of imiglucerase in children and adolescents (2-16 years of age) and adults with Gaucher disease range from 2.5 units/kg 3 times weekly to 60 units/kg every 2 weeks. An imiglucerase dosage of 60 units/kg every 2 weeks is the dosage for which most clinical data are available, but initial disease severity may dictate a relatively high dosage or more frequent administration.
While clinical improvement in hematologic and visceral manifestations generally occurs within the first year of enzyme replacement therapy, response to skeletal manifestations may require 2-3 years of therapy. Some clinicians state that failure to respond within 6 months indicates the need for a higher dosage of imiglucerase.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CEREZYME 400 UNIT VIAL | Maintenance | Adults infuse 2.5 unit/kg over 1-2 hour(s) by intravenous route 3 times per week |
No generic dosing information available.
The following drug interaction information is available for CEREZYME (imiglucerase):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for CEREZYME (imiglucerase):
Drug contraindication overview.
No known contraindications. The manufacturer states that treatment with the drug should be carefully reevaluated if substantial clinical evidence of hypersensitivity develops.
No known contraindications. The manufacturer states that treatment with the drug should be carefully reevaluated if substantial clinical evidence of hypersensitivity develops.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for CEREZYME (imiglucerase):
Adverse reaction overview.
Adverse effects most commonly occurring in children 2-12 years of age receiving imiglucerase include dyspnea, fever, nausea, vomiting, flushing, and coughing. Adverse effects most commonly occurring in adults and adolescents 12-16 years of age receiving imiglucerase include headache, pruritus, and rash.
Adverse effects most commonly occurring in children 2-12 years of age receiving imiglucerase include dyspnea, fever, nausea, vomiting, flushing, and coughing. Adverse effects most commonly occurring in adults and adolescents 12-16 years of age receiving imiglucerase include headache, pruritus, and rash.
There are 7 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Tachycardia |
None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Cyanosis Dyspnea Hypersensitivity drug reaction Urticaria |
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Back pain Chills Diarrhea Fatigue Fever |
Abdominal pain with cramps Dizziness Headache disorder Hypotension Nausea Pruritus of skin Skin rash |
| Rare/Very Rare |
|---|
|
Flushing Hypertension Injection site sequelae |
The following precautions are available for CEREZYME (imiglucerase):
Safety and efficacy of imiglucerase have not been established in children younger than 2 years of age, although the drug has been used in this age group. Use of imiglucerase in pediatric patients 2-16 years of age is principally supported by evidence from adequate and well-controlled studies of the drug and its predecessor (alglucerase (Ceredase(R); no longer commercially available in the US)) in adults and pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) Animal reproductive studies have not been conducted with imiglucerase. The drug should not be administered during pregnancy unless clearly needed and the potential benefits justify the potential risks to the fetus.
It is not known whether imiglucerase is distributed into milk. Caution is advised if the drug is administered in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CEREZYME (imiglucerase):
WARNING: Imiglucerase may cause serious (sometimes fatal) allergic reactions. Get medical help right away if you have any symptoms of a serious allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
WARNING: Imiglucerase may cause serious (sometimes fatal) allergic reactions. Get medical help right away if you have any symptoms of a serious allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
The following icd codes are available for CEREZYME (imiglucerase)'s list of indications:
| Gaucher's disease | |
| E75.22 | Gaucher disease |
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