Lerochol (lerodalcibep-liga) is filed as PCSK9 inhibitor. The sections below restate public label fields stored for this profile.
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 )
Lerodalcibep-liga is a recombinant fusion protein that binds PCSK9.
4 CONTRAINDICATIONS None. None. ( 4 )
Injection site reactions (≥1%); Nasopharyngitis (≥1%); Diarrhea (≥1%); Nausea (≥1%); Peripheral edema (≥1%)
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. Adverse Reactions in Adults with Primary Hypercholesterolemia Adverse Reactions in Two Pooled 52-week Controlled Trials In two pooled 52-week, double-blind, randomized, placebo-controlled trials (Trials 1 and 2), 1,229 patients received 300 mg of LEROCHOL subcutaneously every 4 weeks [see Clinical Studies ( 14 )] . The mean age was 64 years (range 25 to 90 years), 52% were 65 years of age or older, 37% female, 79% White, 18% Black or African American, 4% Asian; 7% identified as Hispanic or Latino ethnicity. At baseline, 9% of patients had a diagnosis of HeFH, 74% had established atherosclerotic cardiovascular disease (ASCVD), and 26% were at increased risk for ASCVD. Adverse reactions reported in at least 2% of LEROCHOL-treated patients and more frequently than in placebo-treated patients are shown in Table 1 . Adverse reactions led to treatment discontinuation in 4% of LEROCHOL-treated patients and placebo-treated patients. The most frequent adverse reaction leading to treatment discontinuation was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% vs. 0%). Table 1: Adverse Reactions Occurring in ≥2% of LEROCHOL-treated Patients with Hypercholesterolemia and > 1% More Frequently than Placebo-treated Patients in Two Pooled 52-Week Trials (Trials 1 and 2) a Grouped terms composed of several similar terms Adverse Reaction a LEROCHOL 300 mg (N=1,229) % Placebo (N=612) % Nasopharyngitis 15 14 Injection site reactions 12 5 Peripheral edema 2 <1 Adverse Reactions in a 24-Week Controlled Trial In a 24-week, double-blind, randomized, placebo-controlled trial (Trial 3), 318 patients with HeFH received 300 mg of LEROCHOL subcutaneously every 4 weeks [see Clinical Studies ( 14 )]. Adverse reactions reported in at least 2% of LEROCHOL-treated patients, and more frequently than in placebo-treated patients are shown in Table 2 . Table 2: Adverse Reactions Occurring in ≥2% LEROCHOL-treated Patients with HeFH and >1% More Frequently than Placebo-treated Patients at 24 Weeks (Trial 3) Adverse Reaction LEROCHOL 300 mg (N=318) % Placebo (N=159) % a Grouped terms composed of several similar terms Injection site reactions a 18 3 Nasopharyngitis a 13 9 Diarrhea 3 1 Nausea 2 0 Peripheral edema a 2 <1
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. 2.2 Recommendations Regarding Missed Dose(s) If a dose is missed by: Less than 7 days, instruct the patient to administer LEROCHOL as soon as possible and resume the patient's original monthly dosage schedule. Seven (7) or more days, instruct the patient to administer LEROCHOL as soon as possible and start a new monthly dosage schedule based on this date. 2.3 Important Administration Instructions Train patients and/or their caregivers on how to prepare and administer LEROCHOL, according to the Instructions for Use, and instruct them to read and follow the Instructions for Use each time they use LEROCHOL. Prior to use, allow LEROCHOL to warm to room temperature up to 25°C (77°F) for at least 30 minutes if LEROCHOL has been refrigerated [see How Supplied/Storage and Handling ( 16 )] . Visually inspect LEROCHOL prior to administration. LEROCHOL is a clear to slightly opalescent, brownish-yellow to amber solution. Do not use if the solution is cloudy or contains particles. Inject LEROCHOL subcutaneously into the abdomen or the upper front thighs. If injected by a healthcare professional or caregiver, the back of the upper arms can also be a site of injection [see Instructions for Use] . Do not inject in an area of the skin that is tender, bruised, red, or indurated. Rotate injection sites for each administration. To administer the full 300 mg dose, push plunger down until the syringe is empty before removing from the injection site.
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use). Administration Provide guidance to patients and caregivers on proper subcutaneous injection technique and how to use the prefilled syringe correctly. Inform patients that the prefilled syringe should be allowed to warm to room temperature for 30 minutes prior to use, if refrigerated [see Dosage and Administration ( 2.3 )]. Manufactured by: LIB Therapeutics, Inc. 5375 Medpace Way Cincinnati, OH 45227-1543 Version 0.5
According to its FDA label, Lerochol (lerodalcibep-liga) is approved 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 subtilis… For medical advice, please talk to your prescriber or pharmacist.
Lerochol (lerodalcibep-liga) belongs to the PCSK9 inhibitor class of medications.
The FDA label lists Lerochol (lerodalcibep-liga) as: 3 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. Injection: 300 mg/1.2 mL (250 mg/mL) solution in a single-dose prefilled syringe. ( 3 ); subcutaneous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Lerochol. Availability changes as patents expire.
Our ingest of the FDA label for Lerochol (lerodalcibep-liga) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Lerochol (lerodalcibep-liga) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Lerochol (lerodalcibep-liga) as 2025-12-12.
The FDA label lists LIB Therapeutics, Inc. as a labeler/manufacturer of Lerochol (lerodalcibep-liga). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. If needed, LEROCHOL may be kept at room temperature up to 25°C (77°F) in the…" Follow the packaging insert for the authoritative guidance.
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