Lerodalcibep-liga
Generic Name: lerodalcibep-liga
Brand Names:
Lerochol
11 DESCRIPTION Lerodalcibep-liga is a recombinant fusion protein therapeutic agent comprised of a proprotein convertase subtilisin/kexin type 9 (PCSK9)-binding domain and human serum albumin (HSA). Lerodalcibep-liga is produced in genetically engineered mammalian (Chinese hamster ovary) cells as a single protein with an approximate molecular weight of 77 kDa.
Overview
11 DESCRIPTION Lerodalcibep-liga is a recombinant fusion protein therapeutic agent comprised of a proprotein convertase subtilisin/kexin type 9 (PCSK9)-binding domain and human serum albumin (HSA). Lerodalcibep-liga is produced in genetically engineered mammalian (Chinese hamster ovary) cells as a single protein with an approximate molecular weight of 77 kDa.
Uses
1 INDICATIONS AND USAGE LEROCHOL TM 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). LEROCHOL is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor 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). ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage of LEROCHOL is 300 mg administered subcutaneously once monthly. ( 2.1 ) Inject LEROCHOL subcutaneously into the abdomen or thigh. A caregiver or healthcare professional can administer into the upper arm. ( 2.2 ) Refer to the Instructions for Use for administration of prefilled syringe. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of LEROCHOL is 300 mg once monthly administered subcutaneously. Assess LDL-C when clinically indicated. The LDL-lowering effect of LEROCHOL may be measured as early as 4 weeks after initiation and, provided monthly dosing is continued, anytime thereafter without regard to timing of the dose.
Side Effects
6 ADVERSE REACTIONS Common adverse reactions occurring in ≥1% of patients treated with LEROCHOL were injection site reactions, nasopharyngitis, diarrhea, nausea and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIB Therapeutics, Inc. at 1-877-2-LEROCHOL or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Warnings
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Discontinue LEROCHOL when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. LEROCHOL 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, LEROCHOL may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )]. In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LEROCHOL (lerodalcibep-liga) injection 300 mg/1.2 mL (250 mg/mL) is supplied as a single-dose prefilled syringe for subcutaneous injection and is a clear to slightly opalescent, brownish-yellow to amber, sterile, preservative-free solution. LEROCHOL is supplied in cartons containing one single-dose prefilled syringe (NDC 84685-300-01).
Frequently Asked Questions
What is Lerodalcibep-liga used for?▼
1 INDICATIONS AND USAGE LEROCHOL TM 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). LEROCHOL is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor 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). ( 1 )
What are the side effects of Lerodalcibep-liga?▼
6 ADVERSE REACTIONS Common adverse reactions occurring in ≥1% of patients treated with LEROCHOL were injection site reactions, nasopharyngitis, diarrhea, nausea and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIB Therapeutics, Inc. at 1-877-2-LEROCHOL or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Lerodalcibep-liga during pregnancy?▼
8.1 Pregnancy Risk Summary Discontinue LEROCHOL when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. LEROCHOL 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, LEROCHOL may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )]. In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy.
What are the important warnings for Lerodalcibep-liga?▼
4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.