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Leqvio Generic Name & Formulations
Legal Class
Rx
General Description
Inclisiran 284mg/1.5mL (189mg/mL); per prefilled syringe; soln for SC inj; preservative-free.
Pharmacological Class
Small interfering RNA (siRNA).
How Supplied
Single-dose prefilled syringe—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Inclisiran is a double-stranded siRNA, conjugated on the sense strand with triantennary N-Acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilizes the RNA interference mechanism and directs catalytic breakdown of mRNA for PCSK9. This increases LDL-C receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in the circulation.
Leqvio Indications
Indications
Adjunct to diet and statin therapy in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
Leqvio Dosage and Administration
Adult
Give by SC inj into abdomen, thigh, or upper arm. Initially 284mg as a single inj, repeat at 3 months, and then every 6 months. Measure LDL-lowering effect as early as 30 days after initiation and anytime thereafter.
Children
Not established.
Leqvio Contraindications
Not Applicable
Leqvio Boxed Warnings
Not Applicable
Leqvio Warnings/Precautions
Warnings/Precautions
Do not inject into areas of active skin disease or injury (eg, sunburns, skin rashes, inflammation, skin infections). ESRD. Severe hepatic impairment. Pregnancy: avoid. Nursing mothers.
Leqvio Pharmacokinetics
Distribution
Plasma protein bound: 87%. Apparent volume of distribution: ~500 L.
Elimination
Renal (~16%). Half-life: ~9 hours.
Leqvio Interactions
Not Applicable
Leqvio Adverse Reactions
Adverse Reactions
Inj site reaction, arthralgia, bronchitis.
Leqvio Clinical Trials
See Literature
Leqvio Note
Not Applicable
Leqvio Patient Counseling
See Literature
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