Quick answers
- What is Asfotase alfa used for?
- The FDA-approved label (Strensiq, Alexion Pharmaceuticals, Inc., December 12, 2025) says: “STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Asfotase alfa have a boxed warning?
- Yes. The FDA label for Strensiq 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 Asfotase alfa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Asfotase alfa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Asfotase alfa?
- 1 company lists prescription products of Asfotase alfa in the FDA NDC Directory, including Alexion Pharmaceuticals Inc..
What Asfotase alfa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
— FDA label: Strensiq, Alexion Pharmaceuticals, Inc., effective December 12, 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: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Strensiq |
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.
- Alexion Pharmaceuticals Inc.4 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125513 STRENSIQ | Alexion Pharm | October 23, 2015 | 4, latest July 10, 2024 2024: Labeling · 2020: Efficacy · 2018: 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Strensiq, Alexion Pharmaceuticals, Inc., effective December 12, 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 →