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Elzonris

tagraxofusp
CD123-Directed CytotoxinFDA Approved 2018Stemline Therapeutics
Route
IV
Half-Life
~13 hrs
FDA Approved
2018
Manufacturer
Stemline Therapeutics
1. Indications and Usage

Adults and pediatric patients 2+ years with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

2. Dosage and Administration

12 mcg/kg IV over 15 minutes on Days 1-5 of each 21-day cycle.

3. Dosage Forms and Strengths

Injection: 1 mg/mL (1 mL) single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Capillary Leak Syndrome: Life-threatening and fatal. Monitor albumin and weight before each dose.
  • Hypersensitivity: Premedicate.
  • Hepatotoxicity: Monitor liver function.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Capillary Leak Syndrome (55%), Nausea (48%), Fatigue (44%), Peripheral Edema (40%), Pyrexia (40%), Weight Increase (36%), ALT Elevation (34%), Hypoalbuminemia (30%)

Capillary Leak Syndrome
55%
Nausea
48%
Fatigue
44%
Peripheral Edema
40%
Pyrexia
40%
Weight Increase
36%
ALT Elevation
34%
Hypoalbuminemia
30%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No formal drug interaction studies conducted.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Tagraxofusp is a CD123-directed cytotoxin: recombinant IL-3 fused to truncated diphtheria toxin. It binds CD123 (overexpressed on BPDCN cells), is internalized, and inhibits protein synthesis causing cell death.

Pharmacokinetics

Half-life: ~40 minutes. Rapid clearance. Volume of distribution: ~4.7 L.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Tagraxofusp Trials on ClinicalTrials.gov ↗ 📚 PubMed: Tagraxofusp Clinical Trials ↗
FDA-Approved Tumor Types

Consult the prescribing information for complete indication details and associated tumor types.

External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Elzonris. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Elzonris (tagraxofusp) approved for?

Elzonris (tagraxofusp) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Elzonris (tagraxofusp) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Elzonris (tagraxofusp) work?

Tagraxofusp is a CD123-directed cytotoxin: recombinant IL-3 fused to truncated diphtheria toxin. It binds CD123 (overexpressed on BPDCN cells), is internalized, and inhibits protein synthesis causing cell death.

What are the most common side effects?

Capillary Leak Syndrome (55%), Nausea (48%), Fatigue (44%), Peripheral Edema (40%), Pyrexia (40%), Weight Increase (36%), ALT Elevation (34%), Hypoalbuminemia (30%) Capillary Leak Syndrome 55% Nausea 48% Fatigue 44% Peripheral Edema 40% Pyrexia 40% Weight Increase 36% ALT Elevation 34% Hypoalbuminem

← All TherapiesFull Prescribing Information ↗