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Molecule

Tagraxofusp

CD123 Interaction
Available on requestBiologicOrphanCold chainOncology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Tagraxofusp is a CD123 interaction indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. It is available as injection for intravenous use. MedsAcross supplies Tagraxofusp for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
CD123 Interaction, Cytotoxin, CD123 Interactions
ATC classification
L01XX67 Tagraxofusp · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XX
US FDA first approval
21 December 2018
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 8ZHS5657EHCAS 2055491-00-2DrugBank DB14731Q60666292

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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

Source: US FDA prescribing information

How it works

Tagraxofusp-erzs is a CD123-directed cytotoxin composed of recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT) fusion protein that inhibits protein synthesis and causes cell death in CD123-expressing cells.

Source: US FDA prescribing information

Dosing overview

Premedicate with an H1-histamine antagonist, acetaminophen, corticosteroid and H2-histamine antagonist prior to each ELZONRIS infusion. Administer ELZONRIS intravenously at 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle. Administer the first cycle of ELZONRIS in the inpatient setting. Subsequent cycles may be administered in the inpatient or appropriate outpatient setting. Additional important preparation and administration information is in full prescribing information. See full prescribing information for instructions on preparation and administration.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (capillary leak syndrome): Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. Hypersensitivity: Monitor patients for signs/symptoms and treat appropriately. Hepatotoxicity: Monitor ALT and AST. Interrupt ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal.

Source: US FDA prescribing information

Side effects

The following serious adverse drug reactions are described elsewhere in the labeling: Capillary Leak Syndrome Hypersensitivity Reactions Hepatotoxicity Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.

Source: US FDA prescribing information

Storage

Store in freezer between -25°C and -15°C (-13°F and 5°F). Thaw vials at room temperature between 15°C and 25°C (59°F and 77°F) prior to preparation.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Tagraxofusp, sorted by availability.

MedicineManufacturerRegisterAvailability
Elzonris 1000 mcg/1 mL injectionIntravenous Cold chainStemline TherapeuticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 21 December 2018Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Tagraxofusp available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Tagraxofusp and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Tagraxofusp have?

The catalogue lists 1 brand names for Tagraxofusp, including Elzonris.

Is Tagraxofusp approved by the US FDA?

Yes. The US FDA first approved Tagraxofusp on 21 December 2018, according to Drugs@FDA.

Is Tagraxofusp authorised in the European Union?

Yes. Tagraxofusp has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Tagraxofusp need cold chain shipping?

At least one listed presentation of Tagraxofusp must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Tagraxofusp in?

Tagraxofusp is classified under ATC code L01XX67 (Tagraxofusp).

References

  1. Elzonris prescribing information (Stemline Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 9 December 2024
  2. Elzonris: European public assessment report (EPAR). European Medicines Agency. Retrieved 27 October 2025

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