LEROCHOL Solution for injection Ref.[116114] Active ingredients: Lerodalcibep

Source: FDA, National Drug Code (US)  Revision Year: 2025 

Product 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.

LEROCHOL (lerodalcibep-liga) injection is a clear to slightly opalescent, brownish-yellow to amber, sterile, preservative-free solution for subcutaneous injection. Each single-dose prefilled syringe contains 1.2 mL of lerodalcibep-liga (300 mg), histidine (3.07 mg), L-histidine monohydrochloride (0.88), polysorbate 80 (0.24 mg), sodium chloride (10.52), and Water for Injection. The pH is 6.8.

Dosage Forms and Strengths

Injection: 300 mg/1.2 mL (250 mg/mL) of clear to slightly opalescent, brownish-yellow to amber solution in a single-dose prefilled syringe.

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).

Manufactured by: LIB Therapeutics, Inc., 5375 Medpace Way, Cincinnati, OH 45227-1543

Drugs

Drug Countries
LEROCHOL United States

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