Moxetumomab Pasudotox-tdfk
Class: Antineoplastic Agents
- Antibody-fusion Proteins
- Immunotoxins
Chemical Name: Disulfide with anti-(human CD22 (antigen)) (synthetic Mus musculus CAT-8015 heavy chain variable region fragment) fusion protein with exotoxin PE38 (Pseudomonas fragment), immunoglobulin
Molecular Formula: C2804H4339N783O870S14
CAS Number: 1020748-57-5
Brands: Lumoxiti
Warning
- Capillary Leak Syndrome
Capillary leak syndrome, sometimes life-threatening, reported. (See Capillary Leak Syndrome under Cautions.)
Temporary interruption of therapy or drug discontinuance may be necessary. (See Dosage Modification for Toxicity under Dosage and Administration.)
- Hemolytic Uremic Syndrome
Hemolytic uremic syndrome, sometimes life-threatening, reported. (See Hemolytic Uremic Syndrome under Cautions.)
Institute appropriate prophylactic measures (e.g., adequate hydration, low-dose aspirin). (See General under Dosage and Administration.)
Discontinuance of therapy may be necessary. (See Dosage Modification for Toxicity under Dosage and Administration.)
Introduction
Antineoplastic agent; a CD22-directed antibody-fusion protein consisting of a recombinant murine monoclonal antibody (moxetumomab) covalently linked to a cytotoxic bacterial protein toxin (Pseudomonas exotoxin [PE38]).
Uses for Moxetumomab Pasudotox-tdfk
Hairy Cell Leukemia
Treatment of relapsed or refractory hairy cell leukemia in patients who previously received ≥2 systemic therapies, including a purine nucleoside analog (e.g., cladribine, pentostatin). Efficacy determined based on durable (lasting >180 days) complete response rate in a noncomparative, open-label, multicenter phase 3 study in patients with relapsed or refractory hairy cell leukemia or hairy cell leukemia-variant previously treated with ≥2 systemic therapies.
Designated an orphan drug by FDA for treatment of hairy cell leukemia.
Moxetumomab Pasudotox-tdfk Dosage and Administration
General
To minimize risk of infusion-related reactions, premedicate with an antihistamine (e.g., diphenhydramine, hydroxyzine), acetaminophen, and a histamine H2-receptor antagonist (e.g. ranitidine, famotidine, cimetidine) 30–90 minutes prior to each infusion. Consider an oral antihistamine and acetaminophen for ≤24 hours after each infusion.
To minimize risk of hemolytic uremic syndrome, administer 1 L (for patients weighing ≥50 kg) or 500 mL (for patients weighing <50 kg) of 5% dextrose injection in 0.45% sodium chloride injection, 5% dextrose in 0.9% sodium chloride injection, or an appropriate isotonic IV solution by IV infusion over 2–4 hours before and after each dose of moxetumomab pasudotox. Also maintain adequate oral hydration on days 1–8 of each 28-day cycle with up to 12 glasses (3 L) of fluids (e.g., water, milk, juice) for patients weighing ≥50 kg or 8 glass
