Anifrolumab
Anifrolumab is a monoclonal antibody medication used to treat moderate to severe systemic lupus erythematosus (SLE) in adult patients. It works by binding to and blocking the type I interferon receptor, which inhibits inflammatory signaling pathways involved in autoimmune responses. This targeted approach helps reduce lupus disease activity in patients who haven't responded adequately to standard treatments.
Anifrolumab is an immunosuppressant monoclonal antibody that treats moderate to severe systemic lupus erythematosus by blocking type I interferon signaling.
Key facts at a glance
- ATC
- L04AG11
- RxNorm
- 2565265
- Generic
- Anifrolumab
- Class
- atc-l04
- Brands
- Saphnelo
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe, 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
7 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 third trimesteravoid
avoid use in second and third trimesters due to increased placental transfer
comprehensive fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding or avoid
do not breastfeed during treatment and for at least 3 months after last dose
none specific
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot indicated
not approved for use in patients under 18 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 yearsno specific adjustment
use with caution; limited data in patients over 65 years
monitor for infections and adverse effects
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentno specific adjustment needed
use with caution; patients with severe renal impairment were excluded from clinical trials
monitor renal function periodically
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentno specific adjustment needed
use with caution; patients with severe hepatic impairment were excluded from clinical trials
monitor liver function tests periodically
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for systemic lupus erythematosus treatment
Drug class
Monoclonal antibody targeting interferon pathway
Indication
Approved for moderate to severe SLE
Route of administration
300mg IV infusion every 4 weeks
Treatment of moderate to severe systemic lupus erythematosus (SLE) in adult patients, particularly those with inadequate response to standard therapy.
Anifrolumab is a human IgG1κ monoclonal antibody that binds specifically to subunit 1 of the type I interferon receptor (IFNAR), inhibiting type I IFN signaling and blocking the biological activity of type I interferons that contribute to lupus inflammation.
Administered as intravenous infusion; carries warnings for serious infections, hypersensitivity reactions, and potential increased risk of malignancy. Patients should be monitored for infections during treatment. Not recommended during pregnancy or breastfeeding. May interact with other immunosuppressive therapies.
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