Lerodalcibep
Lerodalcibep is a PCSK9 inhibitor used to lower LDL cholesterol levels in patients with hyperlipidemia or atherosclerotic cardiovascular disease who need additional LDL-C reduction. It is a recombinant fusion protein that works by binding to PCSK9 and preventing it from degrading low-density lipoprotein receptors in the liver, allowing more LDL to be cleared from the bloodstream.
Lerodalcibep is an injectable PCSK9 inhibitor that lowers LDL cholesterol by preventing liver receptor degradation.
Key facts at a glance
- ATC
- C10AX19
- RxNorm
- 2729426
- Generic
- Lerodalcibep
- Class
- atc-c10
- Brands
- Lerochol
- 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
- 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
13 groupspregnancy
first trimesteravoid if possible
discontinue use during pregnancy unless benefits outweigh risks; consider alternative lipid-lowering therapy
regular fetal monitoring if treatment continues
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
discontinue use during pregnancy; no evidence of teratogenicity but limited human data
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
discontinue use before third trimester if possible
fetal growth monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue
it is unknown whether lerodalcibep passes into breast milk; breastfeeding mothers should either discontinue the drug or stop breastfeeding
monitor infant for any adverse effects
geriatric
elderly 65 yearsno adjustment needed
no dose adjustment required; monitor renal and hepatic function
regular monitoring of lipid levels and adverse effects
pediatric_age
children under 12not recommended
not approved for use in pediatric patients under 12 years; limited safety and efficacy data
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
adolescents 12 17use with caution
limited data available for adolescents; use only in specific cases of familial hypercholesterolemia under specialist supervision
close monitoring for efficacy and safety
Use with caution and monitor for adverse effects.
renal_impairment
mild renal impairmentno adjustment needed
no dose adjustment required for mild renal impairment
standard monitoring
renal_impairment
moderate renal impairmentno adjustment needed
no dose adjustment required for moderate renal impairment; monitor closely
regular renal function monitoring
renal_impairment
severe renal impairmentuse with caution
use with caution in severe renal impairment; limited clinical data
close monitoring of renal function and adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno adjustment needed
no dose adjustment required for mild hepatic impairment
standard monitoring
hepatic_impairment
moderate hepatic impairmentuse with caution
use with caution in moderate hepatic impairment; limited clinical data
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentuse with caution
use with caution in severe hepatic impairment; not extensively studied
close monitoring of liver function and clinical response
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Monoclonal antibody lipid-lowering agent
Mechanism of action
Binds to PCSK9 protein to lower LDL cholesterol
Common uses
Treatment of primary hypercholesterolemia and mixed dyslipidemia
Year of first approval
First approved in European Union
Used to treat hyperlipidemia and reduce cardiovascular risk in patients with established or high risk of atherosclerotic cardiovascular disease who require additional LDL-C lowering beyond statin therapy alone.
As a recombinant fusion protein, lerodalcibep binds PCSK9 with high (picomolar) affinity, blocking PCSK9 from attaching to low-density lipoprotein receptors (LDLR) on hepatocyte surfaces. This prevents PCSK9-mediated LDLR degradation, preserving receptor availability to clear LDL cholesterol from circulation.
Administered via subcutaneous injection. Like other PCSK9 inhibitors, it is typically used as add-on therapy to statins rather than as monotherapy. Patients should be monitored for hypercholesterolemia progression and cardiovascular outcomes. Common side effects may include injection site reactions.
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