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Elzonris Generic Name & Formulations
Legal Class
Rx
General Description
Tagraxofusp-erzs 1000mcg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
CD123-directed cytotoxin.
How Supplied
Single-dose vial (1mL)—1
Manufacturer
Generic Availability
NO
Elzonris Indications
Indications
Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Elzonris Dosage and Administration
Adults and Children
<2yrs: not established. Premedicate with an H1-histamine antagonist, H2-histamine antagonist, corticosteroid, and APAP ~60mins prior to each dose. ≥2yrs: 12mcg/kg via IV infusion over 15mins once daily on Days 1–5 of a 21-day cycle until disease progression or unacceptable toxicity. May extend dosing period for dose delays up to Day 10 of the cycle. Observation following each infusion, dose modifications, and CLS management: see full labeling.
Elzonris Contraindications
Not Applicable
Elzonris Boxed Warnings
Boxed Warning
Capillary leak syndrome (CLS).
Elzonris Warnings/Precautions
Warnings/Precautions
Risk of capillary leak syndrome (may be fatal); monitor for signs/symptoms. Ensure adequate cardiac function and serum albumin ≥3.2g/dL prior to initiation. Monitor serum albumin levels prior to each dose during therapy and clinically thereafter. Monitor for hypersensitivity reactions; interrupt and treat as needed if occurs. Monitor ALT/AST prior to each infusion; withhold if transaminases >5×ULN; resume when resolved. Elderly. Pregnancy: exclude status within 7 days prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥1 week after last dose. Nursing mothers: not recommended (during and for 1 week after last dose).
Elzonris Pharmacokinetics
See Literature
Elzonris Interactions
Elzonris Adverse Reactions
Adverse Reactions
CLS, nausea, fatigue, peripheral edema, pyrexia, weight increase, lab abnormalities; hypersensitivity, hepatotoxicity.
Elzonris Clinical Trials
See Literature
Elzonris Note
Not Applicable
Elzonris Patient Counseling
See Literature
