Inclisiran
Inclisiran is a prescription medication used to treat adults with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who need additional LDL cholesterol lowering beyond statin therapy. It is a double-stranded small interfering RNA (siRNA) that works by targeting and silencing the PCSK9 gene in liver cells, allowing more LDL receptors to clear cholesterol from the blood.
Inclisiran is an injectable siRNA medication that lowers LDL cholesterol by silencing the PCSK9 gene in liver cells.
Key facts at a glance
- ATC
- C10AX16
- RxNorm
- 2588243
- Generic
- Inclisiran
- Class
- atc-c10
- Brands
- Leqvio
- 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
- 284mg
- Maximum
- consult physician
- Frequency
- subcutaneously every 6 months after initial dose and dose at 3 months
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not applicable
- Maximum
- consult physician
- Frequency
- not applicable - not approved for pediatric use
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 284mg
- Maximum
- consult physician
- Frequency
- subcutaneously every 6 months after initial dose and dose at 3 months
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 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 trimesteravoid if possible
discontinue therapy if pregnancy occurs
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near delivery
fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
not applicableavoid
it is unknown whether inclisiran is excreted in human milk; a risk to the breastfed infant cannot be excluded
monitor infant for adverse effects
geriatric
over 65 yearsno dosage adjustment required
no dose adjustment needed; monitor for efficacy and adverse effects
regular monitoring of lipid levels and liver function
Use with caution and monitor for adverse effects.
pediatric_age
under 18 yearsnot established
safety and efficacy not established in pediatric patients; use is not recommended
not applicable
renal_impairment
mild to moderateno dosage adjustment required
no dose adjustment needed for mild to moderate renal impairment
standard monitoring
renal_impairment
severeuse with caution
limited data in severe renal impairment; use with caution
monitor renal function and for adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno dosage adjustment required
no dose adjustment needed for mild to moderate hepatic impairment
monitor liver function tests
Statistics and clinical data
Drug class
Inclisiran is a small interfering RNA (siRNA) that inhibits PCSK9 synthesis
Primary indication
Therapeutic indication for cardiovascular risk reduction
FDA approval year
First FDA approval date for Inclisiran (Leqvio)
Dosing frequency
Subcutaneous administration regimen
Inclisiran is indicated for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-C lowering despite maximally tolerated statin therapy.
Inclisiran is a double-stranded siRNA conjugated with GalNAc that specifically targets and silences the PCSK9 gene in hepatocytes. By reducing PCSK9 protein production, more LDL receptors remain on hepatocyte surfaces to remove LDL cholesterol from circulation.
Administered as a subcutaneous injection by a healthcare provider. Dosing schedule: initial dose, second dose at 3 months, then every 6 months thereafter. Common side effects include injection site reactions, arthralgia, urinary tract infections, and dyspnea. Should be used in conjunction with statin therapy when tolerated.
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