Prescription medicine
Idursulfase Brand names: Elaprase
Idursulfase (Elaprase) is a prescription medicine with an FDA approval on record since 2006. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the idursulfase FDA label on DailyMed (effective April 15, 2025, Takeda Pharmaceuticals America, Inc.); the BLA 125151 record on Drugs@FDA; every idursulfase label on DailyMed.
Highlights of the record
FDA label of April 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF ANAPHYLAXIS.
Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after ELAPRASE infusions, regardless of duration of the course of treatment. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring [see Warnings and Precautions (5.1 , 5.3) and Adverse Reactions (6) ]. WARNING: RISK OF ANAPHYLAXIS See full prescribing information for complete boxed warning. Life-threatening anaphylactic reactions, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. […]
Used for
From the label: indications and usageELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Forms and strengths
- 6 mg/3ml
Solution (concentrate).
On the market
- Earliest approval on file
- July 24, 2006 Elaprase, Shire; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,979 through July 30, 2026
What is idursulfase used for?
From the label: indications and usageELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations (8.4) ]. […]
FDA pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme.
Source: FDA drug label (ELAPRASE), BLA125151 (Shire), as published by Takeda Pharmaceuticals America, Inc., effective April 15, 2025 (SPL set 60cba843-5aab-4dd7-96dc-66648d413be3), via openFDA; the full label on DailyMed
Is there a generic for idursulfase (Elaprase)?
No generic idursulfase is approved (Drugs@FDA, October 8, 2026).
- 2006 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for idursulfase?
The FDA Adverse Event Reporting System holds 3,979 reports that list idursulfase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 684 are coded as a death and 2,174 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other hydrolytic lysosomal glycosaminoglycan-specific enzymes
- the pharmacologic class, with prices and generics
- Idursulfase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other