LEROCHOL (lerodalcibep-liga)

There are 0 contraindications.

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Pregnancy

There are 0 moderate contraindications.

There are 0 severe adverse reactions.

There are 5 less severe adverse reactions.

More Frequent	Less Frequent
Injection site sequelae Pharyngitis	Diarrhea Nausea Peripheral edema

Rare/Very Rare
None.

Discontinue lerodalcibep-liga when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Lerodalcibep-liga increases LDL-C uptake and lowers LDL-C levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, lerodalcibep-liga may cause fetal harm when administered to pregnant patients based on the mechanism of action.

In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. Available data from clinical trials on lerodalcibep-liga use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

In animal reproduction studies, there were no adverse developmental effects observed when pregnant monkeys were administered lerodalcibep-liga subcutaneously during organogenesis and through to parturition at doses up to 100 mg/kg/week (up to 119-fold the exposure at the maximum recommended human dose (MRHD) of 300 mg every month). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no data on the presence of lerodalcebip-liga in human milk, the effects on the breastfed infant, or the effects on milk production. In animal reproduction studies, lerodalcibep-liga was present in the milk of lactating monkeys. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lerodalcibep-liga and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Of the 1,631 patients treated with lerodalcibep-liga 300 mg in clinical trials, 687 (42%) patients were 65 years of age and older, while 198 (12%) patients were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.