INDICATIONLEQVIO® (inclisiran) injection is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH), and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).
IMPORTANT SAFETY INFORMATIONContraindication: LEQVIO is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO. Serious hypersensitivity reactions have included anaphylaxis and angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in patients treated with LEQVIO. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to seek medical attention promptly.
Adverse Reactions: Adverse reactions in clinical trials (≥3% of adult patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, and bronchitis. The safety profile in pediatric patients aged 12 years and older with HeFH or HoFH was consistent with adult patients with hypercholesterolemia, except for a higher frequency of headache in pediatric patients with HeFH.
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Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080