oportuzumab monatox (Pending FDA Approval)

Action and Spectrum

Actions and Spectrum: 

None  

Drug Interaction

Adverse Reaction

Frequency defined  

None 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.   

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.

Pharmacology

Pharmacology  

None  

Pharmacodynamics 

None  

Pharmacokinetics 

Absorption, Distribution, Metabolism and Elimination and Excretion not known for oportuzumab monatox drug. 

Adminstartion

Administration 

oportuzumab monatox is an antibody-drug conjugate that is administered intravenously. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: oportuzumab monatox (Pending FDA Approval) 

Why do we use oportuzumab monatox? 

oportuzumab monatox is an antibody-drug conjugate that combines an anti-epithelial cell adhesion molecule (EpCAM) antibody with a toxin called Pseudomonas exotoxin A.  

oportuzumab monatox is designed to target and bind to EpCAM, a protein that is often overexpressed in urothelial carcinoma cells and deliver the toxin to kill the cancer cells.