Tagraxofusp-erzs

Class: Antineoplastic Agents
Chemical Name: L-Methionyldiphtheria toxin-(1-386)-peptide (1-387) fusion protein with L-arginyl-L-prolyl-L-histidyl-L-methionyl-[8-L-serine(P>S399)]interleukin-3 (Homo sapiens) (388-524), non-glycosylated
Molecular Formula: C₂₅₅₃H₄₀₂₆N₆₉₂O₇₉₈S₁₆
CAS Number: 2055491-00-2
Brands: Elzonris

Medically reviewed by Drugs.com on Sep 21, 2020. Written by ASHP.

Introduction

Antineoplastic agent; CD123-directed fusion protein consisting of recombinant human interleukin-3 (IL-3) linked to truncated diphtheria toxin.

Uses for Tagraxofusp-erzs

Blastic Plasmacytoid Dendritic Cell Neoplasm

Treatment of blastic plasmacytoid dendritic cell neoplasm (designated an orphan drug by FDA for this use).

Efficacy based on rate of complete response (CR) or clinical complete response (CRc) in patients with previously untreated blastic plasmacytoid dendritic cell neoplasm.

Tagraxofusp-erzs Dosage and Administration

General

• Assess vital signs and laboratory parameters (i.e., serum albumin, aminotransferase, and S_cr concentrations) prior to preparation of each dose and as clinically indicated during therapy. For cycle 1 (including at least 24 hours following the last dose of the cycle, monitor in an inpatient setting. For subsequent cycles, administer in a setting where adequate monitoring for patients with hematologic malignancies can be performed for at least 4 hours following each dose.

• To minimize the risk of hypersensitivity reactions, premedicate with an antihistamine (e.g., diphenhydramine), H₂-receptor antagonist, systemic corticosteroid (e.g., IV methylprednisolone 50 mg [or equivalent]), and acetaminophen approximately 60 minutes prior to each infusion.

• Because of the risk of capillary leak syndrome, confirm adequacy of cardiac function prior to initiation of therapy. Delay initial dose of drug until serum albumin concentration is ≥3.2 g/dL. (See Capillary Leak Syndrome under Cautions.)

Restricted Distribution

• Available through designated specialty distributors. Contact manufacturer for additional information.

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion. Use a controlled-infusion device (i.e., syringe pump). To ensure complete administration of the drug, flush infusion set with ≥3 mL of 0.9% sodium chloride injection over 15 minutes using a syringe pump.

Must be diluted prior to administration.

Consult manufacturer’s labeling for detailed information on infusion system requirements (e.g., components, set-up) and procedures for IV infusion.

Dilution

Frozen tagraxofusp-erzs concentrat..