Catumaxomab
- Atc Codes:L01XC09
- CAS Codes:509077-98-9
- PHARMGKB ID:509077-98-9
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Removab; Denmark: Removab; Estonia: Removab; France: Removab; Germany: Removab; Greece: Removab; Ireland: Removab; Latvia: Removab; Lithuania: Removab; Luxembourg: Removab; Malta: Removab; Netherlands: Removab; Portugal: Removab; Slovakia: Removab; Slovenia: Removab; Sweden: Removab.
Drug combinations
Chemistry
Catumaxomab: Rat-mouse hybrid IgG~2~ monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line. CAS-509077-98-9.
Pharmacologic Category
Other Antineoplastic Agents; Monoclonal Antibodies. (ATC-Code: L01XC09).
Mechanism of action
Catumaxomab is a trifunctional rat-mouse hybrid monoclonal antibody specifically directed against the epithelial cell adhesion molecule (EpCAM) and the CD3 antigen. The EpCAM antigen is overexpressed in most carcinomas. CD3 is expressed in mature T-cells as a component of the T-cell receptor. A third functional binding site in the Fc-region of catumaxomab enables interaction with accessory immune cells via Fcγ receptors. Due to catumaxomab’s binding properties, tumor cells, T-cells and accessory immune cells come in close proximity. Thereby, a concerted immunoreaction against tumor cells is induced, which includes different mechanisms of action such as T-cell activation, antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity and phagocytosis. This results in destruction of tumor cells.
Therapeutic use
Intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Pregnancy and lactiation implications
Should not be used during pregnancy unless clearly necessary. Not recommended during lactation.
Unlabeled use
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to murine (rat and/or mouse) proteins.
Warnings and precautions
Treatment in patients with hepatic impairment of a higher severity grade than moderate, and/or with more than 70% of the liver metastasized, and/or portal vein thrombosis/obstruction, or severe renal impairment, should only be considered after a thorough evaluation of benefit/risk. Cytokine release-related symptoms such as fever, nausea, vomiting and chills have been very commonly reported during and after catumaxomab administration. A solid performance status expressed as Body Mass Index >17 (to be assessed after drainage of ascites fluid) and Karnofsky Index >60 is required prior to therapy. Not recommended in presence of factors interfering with the immune system, in particular acute infections. Appropriate medical management of ascites drainage is a prerequisite for treatment in order to assure stable circulatory and renal functions. Induction of human anti-murine (rat and/or mouse) antibodies (HAMAs/HARAs) was observed.