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).
Please see full Prescribing Information.