Leqvio Generic Name & Formulations
Inclisiran 284mg/1.5mL (189mg/mL); per prefilled syringe; soln for SC inj; preservative-free.
Small interfering RNA (siRNA).
Single-dose prefilled syringe—1
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.
Adjunct to diet and statin therapy in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
Leqvio Dosage and Administration
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.
Leqvio Boxed Warnings
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.
Plasma protein bound: 87%. Apparent volume of distribution: ~500 L.
Renal (~16%). Half-life: ~9 hours.
Leqvio Adverse Reactions
Inj site reaction, arthralgia, bronchitis.
Leqvio Clinical Trials
Leqvio Patient Counseling