Tagraxofusp
Tagraxofusp is a CD123-directed cytotoxin used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive hematologic malignancy. It works by delivering a truncated diphtheria toxin directly to cancer cells expressing CD123, which inhibits protein synthesis and causes cell death.
A targeted therapy for BPDCN that delivers diphtheria toxin to CD123-expressing cancer cells.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01XX67
- RxNorm
- 2109055
- Generic
- Tagraxofusp
- Class
- atc-l01
- Brands
- Elzonris
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 12 mcg/kg once daily
- Maximum
- consult physician
- Frequency
- once daily (on days 1-5 of each 21-day cycle)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 12 mcg/kg once daily
- Maximum
- consult physician
- Frequency
- once daily (on days 1-5 of each 21-day cycle)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 12 mcg/kg once daily
- Maximum
- consult physician
- Frequency
- once daily (on days 1-5 of each 21-day cycle)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; consider risks of preterm labor
regular fetal monitoring, assess for fetal growth
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
discontinue breastfeeding or discontinue the drug, taking into account the importance of treatment to the mother
monitor infant for adverse reactions
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot established
safety and effectiveness have not been established in pediatric patients; use only in clinical trials
close monitoring for growth and development
geriatric
elderly 65 and olderno specific adjustment
no dose adjustment required; monitor closely for adverse reactions
monitor renal function, liver function, and for signs of infection
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno specific adjustment
no dose adjustment recommended for mild to moderate renal impairment
monitor renal function during treatment
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno specific adjustment
no dose adjustment recommended for mild to moderate hepatic impairment
monitor liver function tests during treatment
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
First FDA approval for Tagraxofusp (Elzonris)
Drug class
Classification based on mechanism of action
Primary indication
Approved therapeutic indication
Mechanism of action
Primary pharmacologic mechanism
Primarily used for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients (2 years and older). CD123 is highly expressed on BPDCN cells, making this targeted therapy effective for this rare blood cancer.
Tagraxofusp is a fusion protein combining interleukin-3 (IL-3) with truncated diphtheria toxin. The IL-3 portion binds to CD123 receptors on target cells, allowing internalization of the diphtheria toxin component, which then inhibits protein synthesis leading to cell death.
As a cytotoxin, serious side effects including capillary leak syndrome and hepatotoxicity may occur. Treatment should be administered by healthcare providers experienced in managing these complications. Requires pre-medication and monitoring during treatment.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy