Crovalimab
Crovalimab is a monoclonal antibody medication that inhibits the complement protein C5 to prevent terminal complement-mediated cell destruction. It is used to treat conditions where excessive complement activation causes significant clinical problems, such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Crovalimab is a C5 complement inhibitor monoclonal antibody used to treat complement-mediated disorders like PNH by preventing membrane attack complex formation.
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
- L04AJ07
- RxNorm
- 2686619
- Generic
- Crovalimab
- Class
- atc-l04
- Brands
- Piasky
- 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
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteruse only if benefits outweigh risks
consider risks versus benefits carefully
fetal growth monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingno specific adjustment
discontinue breastfeeding or discontinue drug based on importance to mother
monitor infant for adverse effects
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsweight-based dosing
use in pediatric patients based on clinical judgment and approved indications
monitor growth and development
Use with caution and monitor for adverse effects.
geriatric
elderly 65 yearsno specific adjustment required
no dose adjustment needed based on age alone
standard monitoring as appropriate
renal_impairment
mild moderateno specific adjustment
no dose adjustment needed for mild to moderate renal impairment
monitor renal function periodically
Use with caution and monitor for adverse effects.
renal_impairment
severeuse with caution
use with caution and monitor closely
monitor renal function and for adverse reactions
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderateno specific adjustment
no dose adjustment needed for mild to moderate hepatic impairment
monitor liver function
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Classification of Crovalimab as a biologic therapeutic agent
Mechanism of action
Primary pharmacologic mechanism of Crovalimab
Approved indications
Therapeutic indications for Crovalimab (Piasky)
FDA approval year
Initial FDA approval date for Crovalimab
Crovalimab is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), conditions characterized by uncontrolled complement activation leading to red blood cell destruction and systemic complications.
Crovalimab is a humanized monoclonal antibody that binds with high affinity to complement protein C5, preventing its cleavage into C5a (an inflammatory mediator) and C5b (which initiates MAC formation). By blocking C5 activation, it inhibits the formation of the membrane attack complex (MAC), thereby protecting cells from complement-mediated lysis.
Crovalimab carries a risk of serious infections, particularly with encapsulated bacteria. Patients should receive meningococcal vaccination before starting therapy. It is administered via subcutaneous injection. Common side effects may include infusion-related reactions and upper respiratory infections. Close monitoring for hemolysis and clinical response is required during treatment.
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