Anthropometric Measurements as Predictors of Low Birth Weight Among Tanzanian Neonates: A Hospital-Based Study
November 7, 2025
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Brand Name :
Lumoxiti
Synonyms :
Moxetumomab Pasudotox
Class :
Antineoplastics, Monoclonal Antibody
Brand Name :
Lumoxiti
Synonyms :
Moxetumomab Pasudotox
Class :
Antineoplastics, Monoclonal Antibody
Dosing & Uses
Adult Dosing
Dosage forms and strengths
lyophilized powder for reconstitution, injection
1mg/-vial single use
Hairy Cell Leukemia
Moxetumomab pasudotox is planned to be permanently withdrawn from the U.S. market as of August 31, 2023.
It is indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who have previously undergone at least two systemic treatments, including a purine nucleoside analog.
The recommended dosing is 0.04 mg/kg administered intravenously on days 1, 3, and 5 of each 28-day cycle, with each infusion lasting approximately 30 minutes. Treatment may continue for up to six cycles or until disease progression or unacceptable toxicity arises.
Recommended Concomitant Treatments
Hydration:
Before and after each moxetumomab pasudotox infusion, infuse 1 L of isotonic fluid (e.g. 0.9% NaCl or D5W plus 0.45%) intravenous (IV) over 2-4-hour period, and reduce to 0.5 L for patients who weigh less than 50 kg.
Patients should also be encouraged to drink up to 3 liters of oral fluids (juice, milk, water) on days 1-8 of each cycle, and compare for 2 per day for those under 50 kg.
Fluid balance, as well as serum electrolytes, should be monitored to avoid fluid overload or electrolyte instability.
Thromboprophylaxis
Consider administering low-dose aspirin on days 1 through 8 of each cycle and monitor patients for any signs or symptoms of thrombosis.
Premedication
Administer premedication’s 30 to 90 minutes before each infusion, including an antihistamine (such as hydroxyzine or diphenhydramine), an antipyretic like acetaminophen, and an H2 receptor antagonist (such as ranitidine, famotidine, or cimetidine).
Post infusion Medication
Oral antihistamines and antipyretics may be used for up to 24 hours after infusion. An oral corticosteroid (for example, 4 mg dexamethasone) is recommended to reduce nausea and vomiting. Ensure adequate oral fluid intake is maintained.
Safety and efficacy are not established
Refer adult dosing
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Moxetumomab pasudotox is a recombinant immunotoxin composed of a high-affinity anti-CD22 single-chain Fv antibody fused to a truncated fragment of Pseudomonas exotoxin A. After binding the CD22 receptor on malignant B-cells, the complex is rapidly internalised. Inside the cell, the exotoxin domain is released and ADP-ribosylates elongation-factor-2, shutting down protein synthesis and triggering apoptotic cell death. The drug was approved in 2018 for adults with relapsed or refractory hairy-cell leukaemia who had received at least two prior systemic therapies, including a purine-nucleoside analogue. Subsequent commercial uptake was limited, and marketing authorisations were voluntarily withdrawn-first in the European Union in July 202 and then in the United States in 2023.
>10% (Grades 3 or 4)
Platelet count decreased (3.8-11%)
Hypophosphatemia (14%)
Hemoglobin decreased (15%)
Neutrophil count decreased (11-20%)
>10% (All Grades)
Alkaline phosphatase increased (20%)
Hyperuricemia (21%)
Platelet count decreased (21%)
Anemia (21%)
Diarrhea (21%)
Constipation (23%)
Hypomagnesemia (23%)
GGT increased (25%)
Hypokalemia (25%)
Blood bilirubin increased (30%)
Pyrexia (31%)
Headache (33%)
Fatigue (34%)
Capillary leak syndrome (34%)
Nausea (35%)
Peripheral edema (39%)
Hyponatremia (41%)
Neutrophil count decreased (41%)
Hemoglobin decreased (43%)
Infusion-related reactions (50%)
Moxetumomab pasudotox carries a Boxed Warning for capillary leak syndrome (CLS) and hemolytic uremic syndrome (HUS), both of which can be life-threatening and fatal.
Contraindications and Cautions
Contraindications
None
Cautions
Capillary Leak Syndrome (CLS)
Hemolytic Uremic Syndrome (HUS)
Renal Impairment
Electrolyte Imbalance
Pregnancy/Lactation
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Moxetumomab pasudotox is a recombinant anti-CD22 immunotoxin designed to target and eliminate malignant B-cells. It combines a high-affinity single-chain variable fragment (scFv) of a monoclonal antibody directed against CD22, a cell surface antigen expressed on B-cells, with a truncated form of Pseudomonas exotoxin A.
Pharmacodynamics
Moxetumomab pasudotox exerts its effects by specifically binding to the CD22 antigen on B-cell surfaces. Upon binding, the drug is internalized into the malignant B-cells, where its toxin component inhibits protein synthesis by inactivating elongation factor-2 (EF-2). This disruption halts cellular protein production, triggering apoptosis and leading to targeted destruction of CD22-expressing cancer cells. The result is a reduction in tumor burden, particularly in diseases like hairy cell leukemia. The selective mechanism limits damage to non-target cells, contributing to its therapeutic effect.
Pharmacokinetics
Absorption
The peak plasma concentration reaches approximately 379 ng/mL, with an area under the curve (AUC) of 626 ng·h/mL.
Distribution
The volume of distribution (Vd) is estimated to be around 6.5 liters.
Metabolism
While the exact metabolic pathways are not fully characterized, moxetumomab pasudotox, like other protein-based therapeutics, is likely broken down through proteolytic degradation into smaller peptides and amino acids via typical catabolic processes.
Excretion and Elimination
The drug has a half-life of about 1.4 hours. Systemic clearance is approximately 25 L/hr after the initial dose in the first cycle, decreasing to around 4 L/hr with subsequent doses.
Moxetumomab pasudotox is administered as an intravenous (IV) infusion.
Generic Name: moxetumomab pasudotox
Pronounced: (mo” e toom’ oh mab) (pa soo’ doe tox)
Why do we use moxetumomab pasudotox?
Moxetumomab pasudotox is primarily used for the treatment of relapsed or refractory hairy cell leukemia (HCL) in adult patients who have received at least two prior systemic therapies, including a purine nucleoside analog. It targets malignant B-cells expressing the CD22 antigen, helping to reduce tumor burden in this rare type of leukemia.
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