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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

by Drugs.com

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 Drugs.com 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.

References
  • Leqvio (inclisiran) Prescribing Information. FDA Access Data. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214012lbl.pdf
  • Leqvio (inclisiran) [Package Insert] Updated April 1, 2022. Novartis Pharmaceuticals Corporation https://www.drugs.com/pro/leqvio.html

Read next

Leqvio and Repatha are both injectable medicines that are used for the treatment of high cholesterol, by specifically lowering low density lipoprotein (LDL) levels. Although they both inhibit PCSK9 they work by different mechanisms. Repatha is a monoclonal antibody that binds directly to PCSK9 in the liver preventing it from binding to LDL receptors. Leqvio blocks the PCSK9 protein by interfering with the translation of PCSK9 messenger RNA. Both have the same result – and that is freeing up LDL receptors on the surface of liver cells which allows LDL cholesterol to be removed from the blood. Continue reading

The PCSK9 inhibitors are used for the treatment of high-risk patients with elevated cholesterol, especially when statins aren't adequate. They work by blocking PCSK9, leaving more receptors available to capture your "bad" cholesterol (LDL) for break down and removal from the blood. Continue reading

Leqvio may be used alone or with other medications, such as statins, to treat high cholesterol, in addition to a heart-healthy diet. But it can be prescribed without a statin if statins are not tolerated or contraindicated. Continue reading

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