Sutimlimab
Sutimlimab is a monoclonal antibody that inhibits the classical complement pathway by specifically binding to the C1s protein. It is used to treat cold agglutinin disease, a rare autoimmune condition where the immune system mistakenly destroys red blood cells.
Sutimlimab is a complement inhibitor used to treat cold agglutinin disease by blocking the classical complement pathway.
Key facts at a glance
- ATC
- L04AJ04
- RxNorm
- 2591404
- Generic
- Sutimlimab
- Class
- atc-l04
- Brands
- Enjaymo
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; consider discontinuation if pregnancy occurs
regular fetal monitoring and ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
continue only if clearly needed; weigh maternal benefit against fetal risk
regular fetal monitoring including growth assessments
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
consider timing of last dose before delivery; avoid near term if possible
fetal monitoring and assessment of neonatal complement levels
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
discontinue breastfeeding or discontinue drug; decision should be made weighing benefits of breastfeeding for infant against benefits of treatment for mother
monitor infant for signs of infection or immune system effects
geriatric
elderlyno adjustment required
use standard adult dosing; monitor renal function and for infections
regular monitoring of renal function and infection signs
pediatric_age
children under 18not established
not approved for use in pediatric patients; safety and efficacy not established
not applicable as not studied
renal_impairment
mild renal impairmentno adjustment required
no dose adjustment needed for mild renal impairment
routine monitoring of renal function
renal_impairment
severe renal impairmentuse with caution
use with caution; limited data available for severe impairment
close monitoring of renal function and for adverse reactions
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno adjustment required
no dose adjustment needed for mild hepatic impairment
routine liver function monitoring
hepatic_impairment
moderate hepatic impairmentuse with caution
use with caution; limited clinical data available
close monitoring of liver function and clinical response
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for cold agglutinin disease
Drug class
Complement inhibitor class
Primary indication
Therapeutic indication
Mechanism of action
Pharmacological mechanism
Cold agglutinin disease (CAD), a rare form of autoimmune hemolytic anemia where antibodies attack red blood cells in response to cold temperatures.
Binds to complement protein C1s, a serine protease that cleaves C4, thereby inhibiting activation of the classical complement pathway and preventing complement-mediated destruction of red blood cells.
Affects the immune system by inhibiting complement; patients should be monitored for infections. Administered via intravenous infusion. Not recommended for patients with active infections. May increase risk of serious infections including encapsulated bacteria.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy