Sutimlimab Dosage

Medically reviewed by Drugs.com. Last updated on Feb 1, 2023.

Usual Adult Dose for Hemolytic Anemia

39 to less than 75 kg:

• Initial dose: 6500 mg IV once a week for the first 2 weeks
• Maintenance dose: 6500 mg IV every 2 weeks thereafter

At least 75 kg:

• Initial dose: 7500 mg IV once a week for the first 2 weeks
• Maintenance dose: 7500 mg IV every 2 weeks thereafter

Comments:

• This drug should be administered at the recommended dosage regimen time points or within 2 days of these time points.

Use: For the treatment of hemolysis in patients with cold agglutinin disease

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• At least 2 weeks before starting this drug, vaccinate patients against encapsulated bacteria according to the current Advisory Committee on Immunization Practices recommendations for patients with persistent complement deficiencies.
• If urgent use of this drug is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
• For IV infusion only
• This drug can be used as an undiluted or diluted preparation.
• Infuse the undiluted preparation over 1 hour; infuse the diluted preparation over 1 to 2 hours, depending on patient weight.
• Maximum infusion rates for undiluted preparation: 130 mL/hour for patients 39 to less than 75 kg and 150 mL/hour for patients at least 75 kg; patients with cardiopulmonary disease may receive the infusion over 120 minutes.
• Maximum infusion rates for diluted preparation: 250 mL/hour for patients 39 to less than 70 kg and 500 mL/hour for patients at least 70 kg; patients at least 70 kg with cardiopulmonary disease may receive the infusion over 120 minutes.
• Administer the infusion solution only through a 0.2 micron in-line filter with a polyethersulfone (PES) membrane.
• Prime the infusion catheter and tubing (undiluted preparation) or infusion tubing (diluted preparation) with the dosing solution immediately before infusion and flush immediately after completion of the infusion with a sufficient quantity (about 20 mL) of sterile 0.9% Sodium Chloride Injection, USP.
• Slow or stop the infusion if an infusion reaction occurs during administration.
• Monitor patients for at least 2 hours after completion of the initial infusion for signs/symptoms of an infusion and/or hypersensitivity reaction; monitor patients for 1 hour after completion of subsequent infusions for signs/symptoms of an infusion reaction.

Storage requirements:

• Store vials refrigerated at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze or shake.
• Undiluted preparation: Before administration, allow the infusion solution to adjust to room temperature (15C to 25C [59F to 77F]).
• Undiluted or diluted preparation: If the infusion solution is not used immediately, store refrigerated at 2C to 8C (36F to 46F).
• Once removed from refrigeration, allow the infusion solution to adjust to room temperature (15C to 25C [59F to 77F]) and administer within 8 hours; total time from time of preparation, including refrigeration, adjustment to room temperature, and expected infusion time should not exceed 36 hours.
• In-line infusion warmers may be used; do not exceed 40C (104F).

Reconstitution/preparation techniques:

• Diluted preparation: This drug should be diluted with 0.9% Sodium Chloride Injection, USP.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP
• No incompatibilities have been observed between this infusion solution and infusion bags made of di(2-ethylhexyl)phthalate (DEHP) plasticized polyvinyl chloride (PVC), ethylene-vinyl acetate (EVA), and polyolefin (PO); administration sets made of DEHP-plasticized PVC, DEHP-free polypropylene (PP), and polyethylene (PE); and vial adapters made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS).

Monitoring:

• General: For infusion-related reactions
• Hematologic: For signs/symptoms of recurrent hemolysis
• Immunologic: For signs/symptoms of relapse or worsening of autoimmune disease
• Infections/Infestations: For signs/symptoms of worsening infection in patients with active systemic infections

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Seek immediate medical attention if any new symptoms of infection occur.
• Seek medical attention if any new symptoms of infusion-related reactions occur.
• Report any new symptoms of systemic lupus erythematosus and seek medical attention.
• If a dose is missed, administer as soon as possible; thereafter, resume dosing every 2 weeks. If the duration after the last dose exceeds 17 days, administer this drug once a week for 2 weeks and every 2 weeks thereafter.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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