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Where can I find the Leqvio FDA package insert?

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 8, 2022.

Official answer


You can find the Leqvio FDA package insert here on the FDA Access Data website, or read the prescribing information for Leqvio that has been published by which is derived from the product information.

Leqvio (inclisiran) is an injectable medication administered every six months to lower levels of 'bad' cholesterol called low-density lipoprotein (LDL) cholesterol. It belongs to the class of medications known as small interfering RNAs (siRNAs) and was the first one of its class to be approved in 2021. It works by blocking a protein called PCSK9 that is made in the liver. PCSK9 reduces the number of receptors available to clear 'bad' LDL cholesterol from your blood.

The package insert lists all the indications, contraindications, cautions, side effects, dosage schedules, pharmacology, clinical studies, and consumer information for Leqvio.

  • Leqvio (inclisiran) Prescribing Information. FDA Access Data.
  • Leqvio (inclisiran) [Package Insert] Updated April 1, 2022. Novartis Pharmaceuticals Corporation

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