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Brand Name :
Enjaymo, Sutimlimab-jome
Synonyms :
sutimlimab
Class :
Monoclonal Antibodies, Immunomodulators, Complement Inhibitors
Dosage Forms & Strengths
Injectable solution
50mg/ml
Safety and efficacy not determined
Refer to adult dosing
It may diminish the effects when combined with rozanolixizumab by receptor binding competition
Actions and Spectrum
None
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
None
Contraindication/Caution:
None
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
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.
Administration
It is administered as an injectable solution through intravenous route.
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.