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IMPORTANT SAFETY INFORMATION

Adverse Reactions

The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults (including heterozygous familial hypercholesterolemia [HeFH]) ≥2% of patients treated with LEROCHOL^® (lerodalcibep-liga) and occurring more frequently than with placebo were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo) and peripheral edema (2% and <1% versus placebo).

The most commonly occurring adverse reactions in clinical trials in HeFH (≥2% of patients treated with LEROCHOL and occurring more frequently than with placebo) were injection site reactions (18% and 3% versus placebo), nasopharyngitis (13% and 9% versus placebo), diarrhea (3% and 1% versus placebo), nausea (2% and 0% versus placebo) and peripheral edema (2% and <1% versus placebo).

The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% versus 0%).

Immunogenicity

LEROCHOL is a recombinant fusion protein. As with all therapeutic proteins, there is potential for immunogenicity with LEROCHOL.

INDICATIONS

LEROCHOL^® (lerodalcibep-liga) is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

Cardiovascular outcomes trials have demonstrated that reducing LDL‑C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy.

IMPORTANT SAFETY INFORMATION

Adverse Reactions

INDICATIONS