narsoplimab

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. 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

Adverse Reaction 

>10% 

Anemia (18%) 

Abdominal pain (18%) 

Back pain (18%) 

Diarrhea (36%) 

Fatigue (29%) 

Hemorrhage (43%) 

Infection, viral (36%) 

Hypotension (18%) 

Nausea (25%) 

Pyrexia (36%) 

Pneumonia (18%) 

Vomiting (32%) 

Serious infection (36%) 

Neutropenia (36%) 

Sepsis (25%) 

Hypokalemia (25%) 

Black Box Warning

Black Box Warning

None 

Contraindication / Caution

Contraindication/Caution

Contraindication: 

None 

Cautions: 

Severe infections 

• Severe and life-threatening infection reported. 

• These infections involved viral infection, sepsis, bacteremia, pneumonia, gastroenteritis, fungal infection, urosepsis and respiratory tract infection. 

• If it is administered to patient with active infection, monitor closely for symptoms of worsening infection and treat it immediately. 

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. It reduces excessive complement activation and subsequent inflammation, coagulation and cell injury that can occur in conditions like HSCT-TMA and immunoglobulin A (IgA) nephropathy. 

Pharmacodynamics: 

The pharmacodynamics of narsoplimab is studied mainly in conditions like HSCT-TMA and immunoglobulin A (IgA) nephropathy. Research and clinical trials have shown promising results to reduce complement-mediated damage and improving clinical outcomes in patients with these conditions. 

Pharmacokinetics: 

Absorption 

Peak plasma concentration occurs about at the end of every infusion through IV.  

Peak plasma concentrations: 36.9 mcg/mL 

AUC: 2314 mcg⋅hr/mL 

Distribution 

narsoplimab is distributed in blood and hydrophilic extravascular space with average CV% volume of 10.9 L (65%). 

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 by proteolytic cleavage in smaller fragments which are then eliminated. 

Elimination 

Total clearance of narsoplimab is dependent on concentration with estimated mean CV% of 0.12 L per hour (68%) in patient. The mean CV% terminal elimination half life is about 209 hours (73%). 

Adminstartion

Administration 

narsoplimab is administered via intravenous (IV) infusion. It goes directly into the bloodstream through a vein. IV infusion allows for rapid and efficient delivery of the medication which ensure it reaches the target tissues and organs in a controlled and precise manner. 

Administer the diluted medication as a 30-minute intravenous infusion using a PVC or PVC-lined line with a 0.2-micron polyethersulfone (PES) inline filter and a polyurethane catheter. Patients weighing 10 kg or more should receive the infusion from an IV bag by gravity or infusion pump, while those weighing less than 10 kg should receive it via syringe pump.  

If a dose is missed, administer it as soon as possible and then continue with the regular dosing schedule. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: narsoplimab 

Why do we use narsoplimab? 

narsoplimab is used to treat a serious blood vessel condition that can occur after a stem cell transplant. It works by blocking part of the immune system that causes inflammation and damage to small blood vessels. It is administered through a vein as an IV infusion usually once a week. Because it affects the immune system, it may increase the risk of infections and patients should be monitored closely. Common side effects involve diarrhea, nausea, fatigue, fever, infections and bleeding.