sutimlimab

Action and Spectrum

Actions and Spectrum 

None  

Drug Interaction

Adverse Reaction

Frequency defined  

 >10% 

Arthralgia (25%) 

Acrocyanosis (18-21%) 

Fatigue (33%) 

Pyrexia (21%) 

Nasopharyngitis (21%) 

Cough (25%) 

Urinary tract infection (38%) 

Raynaud’s phenomenon (18%) 

Respiratory tract infection (25%) 

Rhinitis (18%) 

Viral infection (21%) 

Abdominal pain (21%) 

Nausea (25%) 

Headache (21-23%) 

Infusion-related reaction (17%) 

Hypertension (23-25%) 

Bacterial infection (25%) 

Peripheral edema (25%) 

Dizziness (29%) 

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 

Patients with CAD (Cold Agglutinin Disease) experience an inhibition of hemolysis when the classic complement pathway is inhibited at the level of C1s because this limit the deposition of complement opsonin’s on the surface of RBCs.   

Pharmacodynamics: None  

Pharmacokinetics 

Absorption, Distribution, Metabolism and Elimination and excretion not known. 

Adminstartion

Administration 

It is administered as an injectable solution through intravenous route.

Patient Information Leaflet

Patient information leaflet 

Generic Name: sutimlimab 

Why do we use sutimlimab? 

Adults with cold agglutinin disorder (CAD) who have haemolysis (the destruction of red blood cells) are treated with sutimlimab.