Quick answers
- What is Idursulfase used for?
- The FDA-approved label (Elaprase, Takeda Pharmaceuticals America, Inc., April 15, 2025) says: “ELAPRASE 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Idursulfase have a boxed warning?
- Yes. The FDA label for Elaprase has a boxed warning (“WARNING: RISK OF ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Idursulfase?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Idursulfase been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Idursulfase?
- 1 company lists prescription products of Idursulfase in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc..
What Idursulfase is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ELAPRASE 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 …
— FDA label: Elaprase, Takeda Pharmaceuticals America, Inc., effective April 15, 2025. 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: RISK OF ANAPHYLAXIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Elaprase |
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.
- Takeda Pharmaceuticals America, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125151 ELAPRASE | Shire | July 24, 2006 | 6, latest November 16, 2018 2018: Labeling · 2013: Efficacy · 2013: Efficacy |
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) | 644104, 647118 |
|---|---|
| SPL set ID of the quoted label | 60cba843-5aab-4dd7-96dc-66648d413be3 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125151 |
| Active ingredients (FDA) | IDURSULFASE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Elaprase, Takeda Pharmaceuticals America, Inc., effective April 15, 2025; 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 →