Quick answers
- What is Tagraxofusp used for?
- The FDA-approved label (Elzonris, Stemline Therapeutics, Inc., December 9, 2024) says: “ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tagraxofusp have a boxed warning?
- Yes. The FDA label for Elzonris has a boxed warning (“WARNING: CAPILLARY LEAK SYNDROME”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tagraxofusp?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tagraxofusp been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tagraxofusp?
- 1 company lists prescription products of Tagraxofusp in the FDA NDC Directory, including Stemline Therapeutics, Inc..
What Tagraxofusp is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
— FDA label: Elzonris, Stemline Therapeutics, Inc., effective December 9, 2024. 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: CAPILLARY LEAK SYNDROME
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Elzonris |
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.
- Stemline Therapeutics, 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 |
|---|---|---|---|
| BLA761116 ELZONRIS | Stemline Therapeutics Inc | December 21, 2018 | 3, latest July 26, 2023 2023: Labeling · 2022: Labeling · 2022: 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) | 2109059, 2109064 |
|---|---|
| SPL set ID of the quoted label | 80eb1080-fe20-4af0-b2a5-a67999923fa8 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761116 |
| Active ingredients (FDA) | TAGRAXOFUSP |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Elzonris, Stemline Therapeutics, Inc., effective December 9, 2024; 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 →