Leukemias, lymphomas, and other hematologic cancers:

Indications for ELZONRIS:

Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

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.

Boxed Warning:

Capillary leak syndrome (CLS).

ELZONRIS Warnings/Precautions:

Risk of capillary leak syndrome; 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 Classification:

CD123-directed cytotoxin.

Adverse Reactions:

CLS, nausea, fatigue, peripheral edema, pyrexia, weight increase, lab abnormalities; hypersensitivity, hepatotoxicity.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (1mL)—1