Quick answers
- What is Imiglucerase used for?
- The FDA-approved label (Cerezyme, Genzyme Corporation, August 27, 2026) says: “CEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. CEREZYME is a hydrolytic lysosomal glucocerebrosidase-specific enzyme indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Imiglucerase have a boxed warning?
- Yes. The FDA label for Cerezyme has a boxed warning (“WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Imiglucerase?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Imiglucerase been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Imiglucerase?
- 1 company lists prescription products of Imiglucerase in the FDA NDC Directory, including Genzyme Corporation.
What Imiglucerase is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. CEREZYME is a hydrolytic lysosomal glucocerebrosidase-specific enzyme indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients.
— FDA label: Cerezyme, Genzyme Corporation, effective August 27, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cerezyme |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Genzyme Corporation1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA020367 CEREZYME | Genzyme | May 23, 1994 | 68, latest January 12, 2026 2026: Efficacy · 2024: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1726266, 1726268 |
|---|---|
| SPL set ID of the quoted label | df60f030-866b-4374-a31f-8ae3f6b45c38 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA020367 |
| Active ingredients (FDA) | IMIGLUCERASE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cerezyme, Genzyme Corporation, effective August 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →