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Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO® and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.
Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- and placebo-treated patients, respectively.
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LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.
Please click here for LEQVIO full Prescribing Information.