narsoplimab (Pending FDA Approval)

Action and Spectrum

Actions and Spectrum: 

Actions: 

narsoplimab is a human monoclonal antibody that targets and inhibits the activity of mannan-binding lectin-associated serine protease-2 (MASP-2). MASP-2 is part of the lectin pathway of the complement system, is reponsible for the immune response and inflammatory processes. By inhibiting MASP-2, narsoplimab interferes with the complement cascade, reducing excessive activation of the immune system and inflammation. 

Spectrum: 

narsoplimab’s approved indications are limited to HSCT-TMA. However, ongoing research and clinical trials are exploring its potential use in other complement-mediated diseases and inflammatory conditions. These may include other kidney diseases, immune complex-mediated disorders, and conditions with dysregulated complement activation. 

Drug Interaction

Adverse Reaction

None reported 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

• Hypersensitivity 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the use of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the usage of drug during pregnancy. 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/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: 

narsoplimab’s pharmacology is centered around its ability to block MASP-2, which inhibits the activation of the lectin pathway of the complement system. Doing so reduces excessive complement activation and subsequent inflammation, coagulation, and cell injury that can occur in conditions like hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and immunoglobulin A (IgA) nephropathy. 

Pharmacodynamics: 

The pharmacodynamics of narsoplimab have been studied primarily in conditions such as hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and immunoglobulin A (IgA) nephropathy. Research and clinical trials have shown promising results in reducing complement-mediated damage and improving clinical outcomes in patients with these conditions. 

Pharmacokinetics: 

Absorption 

narsoplimab is typically administered through intravenous (IV) infusion, allowing rapid and direct delivery into the bloodstream. The rate and extent of absorption are well-characterized with intravenous administration. 

Distribution 

After entering the bloodstream, narsoplimab is distributed throughout the body to various tissues and organs. The volume of distribution indicates the degree to which the drug is distributed throughout the body relative to the plasma concentration. 

Metabolism 

narsoplimab is a monoclonal antibody, and like most antibodies, it is primarily catabolized (broken down) into smaller peptides and amino acids. The metabolism of narsoplimab is likely to occur via proteolytic cleavage into smaller fragments, which are then eliminated. 

Elimination and Excretion 

narsoplimab is primarily eliminated from the body through renal (kidney) clearance. Following catabolism, smaller peptides, and amino acids are filtered via kidneys and excreted in the urine. 

Adminstartion

Administration 

narsoplimab is administered via intravenous (IV) infusion. The drug gets delivered directly into the bloodstream through a vein. IV infusion allows for rapid and efficient delivery of the medication, ensuring it reaches the target tissues and organs in a controlled and precise manner. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: narsoplimab 

Why do we use narsoplimab? 

narsoplimab is investigational, and its safety and efficacy have not been fully established. Clinical trials and studies are ongoing to assess its potential benefits and risks in these medical conditions. As such, narsoplimab may not be approved for routine clinical use in all regions or for all indications as of my last update.