Lerochol (lerodalcibep-liga)

No dosing information is available for this tab.

Administer lerodalcibep-liga subcutaneously.

Prior to use, allow the prefilled syringe to warm to room temperature (up to 25degrees) for at least 30 minutes if it has been refrigerated. Visually inspect the drug prior to administration. Lerodalcibep-liga is a clear to slightly opalescent, brownish-yellow to amber solution; do not use if the solution is cloudy or contains particles.

Inject lerodalcibep-liga subcutaneously into the abdomen (except for the 2-inch area around the navel) or the upper front thigh. If injected by a healthcare professional or caregiver, the back of the upper arms can also be used as a site of injection. Do not inject into skin that is tender, bruised, red, or indurated. Rotate injection sites with each administration.

If a dose is missed by <7 days, administer the dose as soon as possible and resume the regular monthly dosing schedule. If a dose is missed by >=7 days, administer the dose as soon as possible and start a new monthly dosing schedule based on this date.

Prior to use, store the prefilled syringe in the refrigerater at 2-8degrees in the original carton to protect the drug from light. Do not freeze and do not shake. If needed, the drug may be kept at room temperature up to 25degrees in the original carton, but must be used within 3 months of being removed from the refrigerator; if not used within 3 months, discard the drug.

No dosing information is available for this tab.

No formal drug interaction studies have been performed with lerodalcibep-liga. Drug interactions are not expected as lerodalcibep-liga is a recombinant fusion protein, which does not interact with transporters.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

• Pregnancy

There are no moderate contraindications for this drug.

The most common adverse reactions occurring in >=1% of patients treated with lerodalcibep-liga were injection site reactions, nasopharyngitis, diarrhea, nausea and peripheral edema.

There are no severe adverse reactions for this drug.

More Frequent

• Injection site sequelae
• Pharyngitis

Less Frequent

• Diarrhea
• Nausea
• Peripheral edema

No enhanced messaging available.

The safety and effectiveness of lerodalcibep-liga in pediatric patients have not been established. Clinical trials of lerodalcibep-liga in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) have not been conducted. Effectiveness of lerodalcibep-liga was not demonstrated in a 24-week, randomized, open-label, active-controlled trial in 19 pediatric patients 10 to 17 years of age with homozygous familial hypercholesterolemia (HoFH).

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 long-term outcome for most patients with primary hypercholesterolemia.

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.

There are no data on the presence of lerodalcibep-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.

The manufacturer makes no specific dosage recommendation for geriatric patients.

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.