Imiglucerase
Imiglucerase is a recombinant enzyme replacement therapy used to treat Gaucher disease, a rare genetic disorder caused by deficiency of the enzyme β-glucocerebrosidase. By replacing this deficient enzyme, imiglucerase helps break down accumulated glucocerebroside in cells throughout the body, reducing organ damage and improving symptoms.
Imiglucerase is an enzyme replacement therapy for Gaucher disease that helps reduce glucocerebroside buildup in organs.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- A16AB02
- RxNorm
- 84959
- Generic
- Imiglucerase
- Class
- atc-a16
- Brands
- Cerezyme
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesterno specific adjustment
use only if clearly needed and benefits outweigh potential risks
regular prenatal monitoring and fetal assessment
Use with caution and monitor for adverse effects.
pregnancy
second trimesterno specific adjustment
continue therapy if Gaucher disease symptoms require treatment
routine prenatal care
Use with caution and monitor for adverse effects.
pregnancy
third trimesterno specific adjustment
can be continued throughout pregnancy as needed
standard obstetric monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment needed
use with caution and discuss with healthcare provider
monitor infant for any unusual symptoms
pediatric_age
childrendose based on body weight
recommended for pediatric patients with Type 1 Gaucher disease
regular growth and development monitoring
geriatric
elderlyno specific adjustment required
use standard dosing with careful monitoring of organ function
monitor renal and hepatic function
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno dose adjustment required
standard dosing recommended as drug is metabolized proteolytically
routine clinical monitoring
hepatic_impairment
mild to moderateno specific adjustment
use with caution as drug is taken up by macrophages in liver
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval timeline for Imiglucerase
Drug class
Therapeutic classification of Imiglucerase
Primary indication
Primary therapeutic use
Mechanism of action
Pharmacological mechanism
Imiglucerase is indicated for long-term enzyme replacement therapy for patients with Type 1 Gaucher disease (non-neuronopathic), and may also be used for Type 3 (chronic neuronopathic) Gaucher disease. It is used to treat symptoms including anemia, thrombocytopenia, bone disease, hepatomegaly, and splenomegaly associated with the condition.
Imiglucerase is a recombinant form of human β-glucocerebrosidase produced via genetic engineering. The enzyme contains mannose sugars on its surface that allow it to be recognized and internalized by macrophages—the cells where glucocerebroside accumulates in Gaucher disease. Once inside these cells, the enzyme breaks down accumulated glucocerebroside, reducing the burden in the liver, spleen, bone marrow, and other tissues.
Imiglucerase is administered via intravenous infusion, typically every 1-2 weeks, with dosing individualized based on disease severity and response. As a recombinant protein, it carries minimal risk of viral contamination but may cause infusion reactions including headache, nausea, or flushing. Treatment is ongoing and should be initiated and monitored by specialists experienced in Gaucher disease management.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy