Axatilimab
Axatilimab is a monoclonal antibody therapy that targets colony stimulating factor-1 receptor (CSF-1R) on monocytes and macrophages. By blocking CSF-1R, it reduces circulating proinflammatory and profibrotic monocytes, helping to control pathological immune responses and fibrosis. This medication is typically used in patients with inflammatory and fibrotic conditions who have not responded adequately to conventional therapies.
A targeted antibody therapy that reduces inflammatory and fibrotic monocytes by blocking CSF-1R, used for conditions involving abnormal immune responses and tissue fibrosis.
Key facts at a glance
- ATC
- L04AG19
- RxNorm
- 2691526
- Generic
- Axatilimab
- Class
- atc-l04
- Brands
- Niktimvo
- 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
- 0.5 mg/kg (maximum 50 mg)
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.5 mg/kg (maximum 50 mg)
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.5 mg/kg (maximum 50 mg)
- Maximum
- consult physician
- Frequency
- every 2 weeks
- 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; discuss with healthcare provider
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid if possible
continue avoidance; consider discontinuation if pregnancy occurs during treatment
fetal growth monitoring and regular prenatal care
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot recommended
discontinue breastfeeding during treatment and for at least 6 months after last dose
monitor infant for any adverse effects
pediatric_age
children adolescentsnot established
safety and efficacy not established in patients under 12 years; use only in pediatric cGVHD patients when benefits outweigh risks
close monitoring for growth and development
geriatric
elderly 65no specific dose adjustment required
use with caution; no overall differences in efficacy observed but increased sensitivity to infections may occur
monitor for infections and adverse reactions
Use with caution and monitor for adverse effects.
renal_impairment
mild moderate severeno dose adjustment required
no formal dose adjustment needed for renal impairment; not expected to be renally eliminated as it is a monoclonal antibody
standard renal function monitoring
hepatic_impairment
mild moderateno specific dose adjustment
use with caution; limited data in hepatic impairment
monitor liver function tests regularly
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA Approval Date
FDA approval for chronic graft-versus-host disease
Drug class
Pharmacological classification
Indication
Therapeutic indication after failure of one or more lines of systemic therapy
Mechanism of action
Targeted immunotherapy
Used for inflammatory and fibrotic conditions driven by monocyte and macrophage activity, particularly in patients who have failed conventional immunosuppressive therapies.
Axatilimab is a monoclonal antibody that binds specifically to colony stimulating factor-1 receptor (CSF-1R) on the surface of monocytes and macrophages. By blocking this receptor, it inhibits CSF-1R signaling, which reduces the survival, proliferation, and function of these proinflammatory and profibrotic cell populations.
As an immunosuppressive agent, axatilimab may increase susceptibility to infections. Patients should be monitored for signs of infection and liver function during treatment. Infusion reactions may occur. Healthcare providers should review complete prescribing information for complete safety guidance.
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