Version May 2024
Note: Consider for use in patients who do not meet cholesterol treatment goals with dietary modification and other lipid-lowering therapies (eg, maximally tolerated statin plus ezetimibe and/or a PCSK9 monoclonal antibody). Inclisiran should be reserved for patients who cannot use a PCSK9 monoclonal antibody; do not use in combination with a PCSK9 monoclonal antibody since there is no evidence for additive low-density lipoprotein cholesterol lowering (Ref).
Atherosclerotic cardiovascular disease, primary or secondary prevention (secondary prevention is off-label use) (adjunctive agent): SUBQ: Initial: 284 mg as a single injection, again at 3 months, and then every 6 months thereafter (Ref).
Heterozygous familial hypercholesterolemia: SUBQ: Initial: 284 mg as a single injection, again at 3 months, and then every 6 months thereafter.
Missed dose: If a dose is missed by <3 months from the usual day of administration, administer the dose as soon as possible and then resume the original schedule. If a dose is missed by >3 months, skip the missed dose and restart with a new dosing schedule as initial dose, then again at 3 months, and then every 6 months.
Mild to severe impairment: No dosage adjustment necessary.
End-stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
1% to 10%:
Immunologic: Antibody development (5%)
Local: Injection-site reaction (8%; including erythema at injection site, pain at injection site, rash at injection site)
Neuromuscular & skeletal: Arthralgia (5%)
Respiratory: Bronchitis (4%)
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to inclisiran or any component of the formulation; also refer to statin or other lipid-lowering agents' contraindications when used in combination with inclisiran.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous, as sodium [preservative free]:
Leqvio: 284 mg/1.5 mL (1.5 mL)
No
Solution Prefilled Syringe (Leqvio Subcutaneous)
284 mg/1.5 mL (per mL): $2,698.73
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous, as sodium:
Leqvio: 284 mg/1.5 mL (1.5 mL)
SUBQ: Administer by SUBQ injection into the abdomen, upper arm, or thigh. Do not inject in areas of active skin disease or injury (eg, sunburns, skin rashes, inflammation, skin infections).
Atherosclerotic cardiovascular disease, primary prevention: For patients with primary hyperlipidemia as an adjunct to diet and maximally tolerated statin therapy to reduce low-density lipoprotein cholesterol (LDL-C).
Heterozygous familial hypercholesterolemia: Adjunct to diet and maximally tolerated statin therapy to reduce LDL-C.
Atherosclerotic cardiovascular disease, secondary prevention
None known.
There are no known significant interactions.
Based on the mechanism of action, in utero exposure to inclisiran may cause fetal harm. Inclisiran should be discontinued as soon as pregnancy is recognized.
It is not known if inclisiran is present in breast milk.
Inclisiran has poor oral absorption, therefore, if present in breast milk it is unlikely to impact infant development. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Lipid profile (fasting or nonfasting) before initiating treatment; fasting lipid profile should be rechecked 4 to 12 weeks after starting therapy and every 3 to 12 months thereafter (AHA/ACC [Grundy 2018]); low-density lipoprotein-cholesterol may be checked as early as 30 days after initiation and anytime thereafter without regard to timing of the dose.
Inclisiran is a small interfering ribonucleic acid, conjugated on the sense strand with triantennary N-Acetylgalactosamine to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilizes the RNA interference mechanism and directs catalytic breakdown of mRNA for PCSK9. This increases low-density lipoprotein-cholesterol (LDL-C) receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in the circulation.
Distribution: Vd: ~500 L.
Protein binding: 87%.
Metabolism: Primarily by nucleases to shorter nucleotides of varying length.
Half-life elimination: ~9 hours.
Time to peak: ~4 hours.
Excretion: Renal (~16%).
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