NJmo Injection (Sutimlimab)

Adult dosage

The dosage of this medication is determined based on body weight. For patients weighing between 39 kg and 75 kg, a dosage of 6,500 mg is administered, and for patients weighing 75 kg or more, a dosage of 7,500 mg is given. During the first 2 weeks, it is administered intravenously once a week, and thereafter every 2 weeks. This drug must be administered via intravenous infusion, and rapid intravenous injection or bolus injection is not allowed.

This medication should not be administered to patients who are hypersensitive to the active substance or any of the excipients. This drug targets complement protein C1s, which may increase the risk of infection, so vaccinations against encapsulated bacteria such as meningococci and pneumococci must be ensured. This medication should not be given to patients with active severe infections, and if infection symptoms are suspected, immediate medical evaluation is required. Patients at high risk of infection or those with immunocompromised states require special precautions. Serious hypersensitivity reactions such as anaphylaxis may occur during administration; therefore, if symptoms of hypersensitivity appear, the administration should be stopped immediately and appropriate treatment should be sought. Infusion-related reactions may occur during or shortly after infusion; thus, patients must be carefully monitored. Patients with systemic lupus erythematosus or those with signs of this disease should be careful when using this medication. Appropriate evaluation is needed upon the occurrence of symptoms. Discontinuation of this medication may lead to the recurrence of hemolytic symptoms; therefore, it is essential to closely monitor symptoms and blood values and resume treatment if necessary. The safety of this drug during pregnancy has not been established; thus, the risks to the fetus and the maternal benefits should be carefully evaluated. When breastfeeding, this drug may be passed into breast milk, so risks to the nursing infant should be weighed against the maternal benefits. Safety and efficacy in children under 18 years of age have not been established. While no dose adjustment is necessary for elderly patients over 65 years of age, caution is advised as they may have increased sensitivity. In case of overdose, administration should be stopped immediately, and the patient's condition should be closely monitored. This medication must be stored in a refrigerating condition and checked for particulates or discoloration before administration, and should be used as soon as possible after preparation. This drug should not be mixed with any other drugs and must be administered using a 0.22-micron filter.

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, breathing abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary output is

Mild side effects

• Headache
• hypertension
• urinary tract infection
• upper respiratory tract infection
• nasopharyngitis
• nausea
• abdominal pain
• infusion-related reactions
• cyanosis
• rhinitis

This medication must be stored in a sealed container to protect it from exposure to air and light. It should be stored at a refrigerated temperature of between 2°C and 8°C, and must not be frozen. Storing it this way will maintain the drug's effectiveness and allow for safe use.

Appearance

A clear to slightly milky, colorless to pale yellow solution contained in a colorless, transparent glass vial for injection

Package unit

1 vial/box [vial (1100 mg/22 mL)], 6 vials/box [vial (1100 mg/22 mL)]