Ravulizumab
Ravulizumab is a monoclonal antibody medication that works as a terminal complement inhibitor by specifically binding to the complement protein C5. It prevents the cleavage of C5 into C5a (a proinflammatory substance) and C5b (which initiates the membrane attack complex that damages cells). This medication is used to treat conditions caused by uncontrolled complement activation, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis, and neuromyelitis optica spectrum disorder (NMOSD).
Ravulizumab is a complement inhibitor that targets the C5 protein to treat rare disorders involving abnormal complement system activation.
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
- L04AJ02
- RxNorm
- 2107301
- Generic
- Ravulizumab
- Class
- atc-l04
- Brands
- Ultomiris
- 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
- Weight-based loading dose then maintenance
- Maximum
- consult physician
- Frequency
- Loading dose then every 8 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- Weight-based loading dose then maintenance
- Maximum
- consult physician
- Frequency
- Loading dose then every 8 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- Weight-based loading dose then maintenance
- Maximum
- consult physician
- Frequency
- Loading dose then every 8 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the mother outweigh potential fetal risks
regular fetal monitoring including ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteruse only if clearly needed
continue only if benefits outweigh potential risks; consider treatment continuation if disease flare poses greater risk
regular prenatal check-ups and fetal growth monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse only if clearly needed
use with caution; consider timing of last dose before delivery to minimize neonatal exposure
close fetal monitoring and planning for delivery
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
discontinue breastfeeding or avoid ravulizumab during lactation due to unknown excretion in breast milk
no specific monitoring requirements established
geriatric
elderlyno dose adjustment required
no specific dose adjustment needed for patients 65 years and older; monitor for infections
routine monitoring for infections and treatment response
pediatric_age
children adolescentsweight-based dosing required
approved for pediatric patients with PNH, aHUS, and gMG; use weight-based loading and maintenance dosing
monitor for infections, treatment response, and growth parameters
renal_impairment
mild to moderateno dose adjustment required
no dose adjustment needed for mild, moderate, or severe renal impairment
routine renal function monitoring
hepatic_impairment
mild to moderateno specific guidance available
use with caution; limited clinical data in patients with hepatic impairment
monitor liver function tests and treatment response
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Ravulizumab is a humanized monoclonal antibody that inhibits complement protein C5
FDA approval year
First FDA approval date for Ravulizumab (Ultomiris)
Common uses
Approved therapeutic indications
Mechanism of action
Pharmacological mechanism of action
Ravulizumab is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody positive, and neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 antibody positive.
As a terminal complement inhibitor, ravulizumab binds with high affinity to the complement protein C5, preventing its cleavage into C5a (a proinflammatory anaphylatoxin) and C5b (the initiating subunit of the membrane attack complex). By blocking this final step of the complement cascade, it prevents complement-mediated cell destruction and tissue damage.
Ravulizumab carries a boxed warning for serious meningococcal infections due to terminal complement inhibition. Patients must receive meningococcal vaccines before treatment and be monitored for signs of infection. It is administered via intravenous infusion, typically every 8 weeks after an initial loading dose. Other potential risks include infusion-related reactions and increased susceptibility to other infections.
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