Sarilumab
Sarilumab is a monoclonal antibody medication that blocks the IL-6 receptor, a key protein involved in inflammation. It is prescribed for adults with moderate to severe rheumatoid arthritis who have not adequately responded to other disease-modifying antirheumatic drugs.
Sarilumab is an IL-6 receptor antagonist used to treat moderate to severe rheumatoid arthritis by reducing inflammation.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L04AC14
- RxNorm
- 1923319
- Generic
- Sarilumab
- Class
- atc-l04
- Brands
- Kevzara
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe
- 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
- 200mg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not approved for pediatric use
- Maximum
- consult physician
- Frequency
- not applicable
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 200mg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; discontinue therapy if pregnancy occurs
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
continue avoidance; consider risks vs benefits with rheumatologist
fetal growth monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use; potential risk of immune suppression in newborn
monitor neonatal immune function after birth
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
not recommendeddiscontinue breastfeeding or discontinue drug
do not breastfeed during treatment and for at least 3 months after last dose
no specific monitoring required
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
not approved under 18not applicable
not approved for use in pediatric patients; safety and efficacy not established
not applicable
geriatric
elderly 65 years and olderno dose adjustment required
use with caution; increased risk of infections; monitor for signs of infection
regular monitoring for infections and hematologic parameters
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno dose adjustment required
no dose adjustment needed for mild to moderate renal impairment
routine monitoring as per prescribing guidelines
renal_impairment
severeuse with caution
limited data available; use only if benefits outweigh risks
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severeavoid use
not studied in hepatic impairment; avoid use in patients with active hepatic disease or hepatic impairment
monitor liver function tests regularly
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
Initial FDA approval for Sarilumab (Kevzara)
Drug class
Biological response modifier - monoclonal antibody
Common uses
Indicated for adult patients with moderately to severely active rheumatoid arthritis
Mechanism of action
Binds to IL-6 receptors, blocking interleukin-6 mediated signaling
Treatment of moderate to severe rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). It may be used as monotherapy or in combination with methotrexate.
Sarilumab is a human monoclonal antibody that binds to both soluble and membrane-bound interleukin-6 (IL-6) receptors, preventing IL-6 from activating its signaling pathways. Since IL-6 is a key pro-inflammatory cytokine involved in the inflammatory process of rheumatoid arthritis, blocking this pathway reduces joint inflammation and damage.
Administered as a subcutaneous injection, typically every two weeks. Patients should be monitored for serious infections, as immunosuppression increases infection risk. Laboratory abnormalities including decreased neutrophil count, increased liver enzymes, and elevated lipids may occur. Live vaccines should be avoided during treatment. Not recommended during pregnancy or breastfeeding.
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