Zilucoplan
Zilucoplan is a complement C5 inhibitor used for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody positive. It works by binding to complement protein C5 and preventing its cleavage to C5a and C5b, which inhibits the formation of the terminal complement complex (C5b-9/membrane attack complex) that contributes to neuromuscular junction damage.
A complement inhibitor injection for generalized myasthenia gravis that blocks C5 protein to prevent complement-mediated neuromuscular damage.
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
- L04AJ06
- RxNorm
- 2672489
- Generic
- Zilucoplan
- Class
- atc-l04
- Brands
- Zilbrysq
- 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
- 0.3 mg/kg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.3 mg/kg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.3 mg/kg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
14 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular fetal monitoring and ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular fetal monitoring and ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
use only if benefits outweigh potential risks; consider timing of delivery
regular fetal monitoring and assessment of neonatal complement levels
Use with caution and monitor for adverse effects.
lactation
breastfeedingno specific adjustment
decide whether to discontinue breastfeeding or discontinue drug considering benefit to mother
monitor infant for signs of infection or immune system effects
geriatric
elderly 65 74no adjustment required
no dose adjustment needed based on age alone; monitor renal function
routine monitoring of renal function
geriatric
elderly 75 plusno adjustment required
no dose adjustment needed based on age alone; use with caution in frail patients
routine monitoring of renal function and overall clinical status
pediatric_age
children 2 17not established
not recommended; safety and efficacy not established in pediatric patients
not applicable
pediatric_age
infantsnot applicable
not recommended for use in infants
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mildno adjustment required
no dose adjustment needed for mild renal impairment
routine monitoring
renal_impairment
moderateuse with caution
use with caution; no specific dose adjustment in clinical trials
monitor renal function more closely
Use with caution and monitor for adverse effects.
renal_impairment
severeuse with caution
use with caution; limited clinical data available
monitor renal function closely
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno adjustment required
no dose adjustment needed for mild hepatic impairment
routine monitoring
hepatic_impairment
moderateuse with caution
use with caution; limited clinical data available
monitor liver function tests
Use with caution and monitor for adverse effects.
alcohol_users
regular useno specific adjustment
avoid or limit alcohol consumption; alcohol may exacerbate myasthenia gravis symptoms
monitor for increased muscle weakness or disease exacerbation
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for generalized myasthenia gravis
Drug class
Complement inhibitor classification
Indication
Therapeutic indication
Mechanism of action
Pharmacological mechanism
Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Zilucoplan is a macrocyclic peptide that binds to complement protein C5 with high affinity, inhibiting its cleavage into C5a and C5b. This prevents assembly of the terminal complement complex (C5b-9), thereby reducing complement-mediated damage at the neuromuscular junction.
Administered as a once-daily subcutaneous injection. Patients should be monitored for signs of infection, particularly with encapsulated bacteria. May increase susceptibility to serious infections. Hypersensitivity reactions are possible. Not recommended for use in patients with unresolved serious 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