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Elzonris Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
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.
Elzonris Indications
Indications
Elzonris Dosage and Administration
Adults and Children
Elzonris Contraindications
Not Applicable
Elzonris Boxed Warnings
Boxed Warning
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
Absorption
Following administration of tagraxofusp-erzs 12 mcg/kg, the mean (SD) area under the plasma drug concentration over time curve (AUC) was 231 (123) hr·mcg/L and maximum plasma concentration (Cmax) was 162 (58.1) mcg/L.
Distribution
Mean volume of distribution: 5.1 (1.9) L.
Elimination
Half-life: 0.7 (0.3) hours. Mean clearance: 7.1 (7.2) L/hr.
Elzonris Interactions
Not Applicable
Elzonris Adverse Reactions
Adverse Reactions
Elzonris Clinical Trials
See Literature
Elzonris Note
Not Applicable
Elzonris Patient Counseling
See Literature
