inolimomab (Pending FDA Approval)

Action and Spectrum

Actions and Spectrum  

The CD25 antigen, which is expressed by activated T cells, especially those involved in graft-versus-host disease (GvHD), is the target of inolimomab’s action. Inolimomab prevents these T cells from becoming activated and from multiplying by attaching to CD25.  

The immune response underlying GvHD is precisely targeted and modulated by inolimomab. In adult patients, it is primarily approved for the treatment of acute steroid-resistant or steroid-dependent GvHD. 

Drug Interaction

Adverse Reaction

None 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution:   

None  

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  

inolimomab is a monoclonal antibody that specifically targets and binds to a protein known as CD25, which is expressed as activated T-lymphocytes. CD25 is a subunit of the interleukin-2 (IL-2) receptor, and its binding is involved in the activation and proliferation of T-lymphocytes. 

By binding to CD25, inolimomab inhibits the binding of IL-2 to its receptor and subsequently disrupts the IL-2 signaling pathway.  

Pharmacodynamics  

The intended pharmacodynamic effects of inolimomab include a reduction in T-lymphocyte activation and proliferation. By blocking IL-2 signalling, inolimomab aims to dampen the immune response, specifically in the context of graft-versus-host disease (GvHD) following stem cell or bone marrow transplant. 

Pharmacokinetics 

Absorption 

inolimomab is administered intravenously, which ensures rapid and complete absorption of the medication into the systemic circulation. 

Distribution  

inolimomab is expected to distribute throughout the body, including the extravascular spaces.  

Metabolism   

The metabolism of inolimomab has yet to be studied or documented. 

Elimination and Excretion 

The excretion pathway of inolimomab has yet to be well defined. 

Adminstartion

Administration  

inolimomab is typically administered through the intravenous (IV) route. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: inolimomab (Pending FDA Approval) 

Why do we use inolimomab?  

inolimomab has mainly been researched for its possible application in treating graft-versus-host disease (GvHD).