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LEROCHOL lerodalcibep-liga 300 mg/1.2mL Injection, Solution, 1 syringe — NDC 84685-0300-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LEROCHOL lerodalcibep-liga 300 mg/1.2mL Injection, Solution, 1 syringe — NDC 84685-300-01 (Billing 84685-0300-01)

by LIB Therapeutics, Inc. · 1 SYRINGE in 1 CARTON / 1.2 mL in 1 SYRINGE

This is a package of 1 syringe of LEROCHOL lerodalcibep-liga 300 mg/1.2mL Injection, Solution from LIB Therapeutics, Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 84685-0300-01
🏷️ FDA NDC (as labeled) 84685-300-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 84685-300-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
84685 labeler · 300 product · 01 package
Package marketed since
Mar 31, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8468530001 4
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84685-300-01
Product NDC 84685-300
11-digit billing NDC 84685030001
NCPDP billing unit ML — per mL (volume)
RxCUI 2729467, 2729474
UNII 1PHP3QG5PZ
Application # BLA761427
SPL Set ID 422f8b04-6ce8-4e64-a0a9-0ccc9a4a5860
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-15
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance LERODALCIBEP
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 088520
GCN 58655
HICL code 051073
Ingredient (HICL) Lerodalcibep-Liga
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4T
Therapeutic class — specific (HIC3) Antihyperlipidemic - Pcsk9 Inhibitors
AHFS code 24:06.24.00
AHFS class Pcsk9 Inhibitors
FDB label name LEROCHOL 300 MG/1.2 ML SYRINGE
FDB brand name Lerochol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088520
  • GCN: 58655
  • HICL (First Databank): 051073
  • AHFS class code: 24:06.24.00
  • RxCUI (RxNorm): 2729467
Why two NDCs? The FDA registers this code as 84685-300-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84685-0300-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other lipid modifying agents class.

Drug family (ATC) Other lipid modifying agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LEROCHOL 300 MG/1.2 ML SYRINGE Ingredient Lerodalcibep-Liga
📖 What it is MedlinePlus · NLM

Lerodalcibep-liga injection is used to lower cholesterol (fat-like substance that can build up and clog blood vessels causing heart attack or stroke or other health condition). Lerodalcibep-liga is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibodies. It works by stopping the production of cholesterol.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lerochol works by blocking a protein in your body called PCSK9, which normally destroys the receptors your liver uses to pull LDL ('bad') cholesterol out of your blood. By blocking...
  • What exactly does Lerochol do, and why do I need a shot instead of a pill?
  • You only need one injection per month — that's it. You can give it yourself in your abdomen or the front of your thighs. If a caregiver or healthcare professional is helping, the b...
  • How often do I have to take this, and where do I inject it?
📖 Read our full Lerodalcibep-Liga guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84685-0300-01 You're viewing this Main listing 1 SYRINGE in 1 CARTON / 1.2 mL in 1 SYRINGE 2026-03-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lerochol 300 mg/1.2mLthis 84685-0300-01 LIB 1 syringe — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 12, 2025 ⏳ ~11.2 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Lerochollerodalcibep-liga
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateDec 12, 2037
Common questions
Is there a biosimilar for LEROCHOL 300 MG/1.2 ML SYRINGE?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Lerodalcibep-Liga inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 3.07 mg / 1.2 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 0.88 mg / 1.2 mL UNII 1D5Q932XM6
    An amino acid salt used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in liquid formulations to keep the drug stable and effective.
  • 0.24 mg / 1.2 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 10.52 mg / 1.2 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLIB Therapeutics, Inc.
FDA applicationBLA761427 (BLA)
Labeler code84685
First marketedDec 2025
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 67 words ▾

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 and Administration ~2 min read ▾

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 )

2.1Recommended 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.

2.2Recommendations 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.

2.3Important 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.

💊 Dosage Forms and Strengths 40 words ▾

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 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

🤒 Adverse Reactions ~2 min read ▾

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 .

6.1Clinical 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

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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. 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 LEROCHOL 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.

Data Animal Data In cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when lerodalcibep-liga was dosed during organogenesis and through parturition at 30 and 100 mg/kg subcutaneously once weekly (exposures up to 119-fold the MRHD by AUC). An assessment of immune function in the infants showed no treatment-related adverse effects. Measurable lerodalcibep-liga serum concentrations were observed in the infant monkeys with infant serum concentrations approximately 2 to 7% of maternal serum concentrations on postnatal days 14, 21 and 28, indicating that lerodalcibep-liga has the potential to be transmitted from the mother to the developing fetus.

8.2Lactation Risk Summary 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 (see Data ). 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 LEROCHOL and any potential adverse effects on the breastfed infant from LEROCHOL or from the underlying maternal condition. Data Low concentrations of lerodalcibep-liga were measured in milk samples collected from monkeys on post-partum day (PPD) 7 and PPD 14, when lerodalcibep-liga was dosed during organogenesis through parturition at 30 and 100 mg/kg subcutaneously once weekly (exposures up to 119-fold the MRHD by AUC).

There is no information regarding whether lerodalcibep-liga ingested with milk transfers to neonatal or infant monkey circulation.

8.4Pediatric Use The safety and effectiveness of LEROCHOL in pediatric patients have not been established. Clinical trials of LEROCHOL in pediatric patients with HeFH have not been conducted. Effectiveness of LEROCHOL was not demonstrated in a 24-week, randomized, open-label, active-controlled trial (NCT04034485) in 19 pediatric patients aged 10 to 17 years with homozygous familial hypercholesterolemia (HoFH).

8.5Geriatric Use Of the 1,631 patients treated with LEROCHOL 300 mg in clinical trials, 687 (42%) patients were 65 years of age and older, while 198 (12%) patients were 75 years… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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. 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 LEROCHOL 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.

Data Animal Data In cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when lerodalcibep-liga was dosed during organogenesis and through parturition at 30 and 100 mg/kg subcutaneously once weekly (exposures up to 119-fold the MRHD by AUC). An assessment of immune function in the infants showed no treatment-related adverse effects. Measurable lerodalcibep-liga serum concentrations were observed in the infant monkeys with infant serum concentrations approximately 2 to 7% of maternal serum concentrations on postnatal days 14, 21 and 28, indicating that lerodalcibep-liga has the potential to be transmitted from the mother to the developing fetus.

🧒 Pediatric Use 57 words ▾

8.4Pediatric Use The safety and effectiveness of LEROCHOL in pediatric patients have not been established. Clinical trials of LEROCHOL in pediatric patients with HeFH have not been conducted. Effectiveness of LEROCHOL was not demonstrated in a 24-week, randomized, open-label, active-controlled trial (NCT04034485) in 19 pediatric patients aged 10 to 17 years with homozygous familial hypercholesterolemia (HoFH).

🧓 Geriatric Use 57 words ▾

8.5Geriatric Use Of the 1,631 patients treated with LEROCHOL 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lerodalcibep-liga is a recombinant fusion protein that binds PCSK9 with picomolar affinity. PCSK9 binds to low-density lipoprotein receptor (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, lerodalcibep-liga increases the number of LDLRs available to clear LDL-C from the blood, thereby lowering LDL-C levels. [see Clinical Pharmacology ( 12.3 )] .

12.2Pharmacodynamics After subcutaneous administration of 300 mg lerodalcibep-liga every month, greater than 90% suppression of PCSK9 occurs within 24 hours after dosing and is maintained throughout the dosing interval, returning toward baseline during the last 7 to 10 days of the monthly dosing period.

12.3Pharmacokinetics Following a single subcutaneous administration, exposure to lerodalcibep-liga increased in a dose proportional manner over the dose range 75 to 300 mg of lerodalcibep-liga. Lerodalcibep-liga pharmacokinetics were observed at steady state in patients at the approved recommended dosage and are presented as mean (SD), unless otherwise specified. Lerodalcibep-liga maximum concentration (Cmax) is 31.4 (10.2) mcg/mL, and total systemic exposure (AUC0-tau) is 12,600 (5,190) (hrs*mcg/mL) following subcutaneous dose of lerodalcibep-liga 300 mg once every four weeks.

Lerodalcibep-liga steady-state is reached following 2 to 3 doses. Lerodalcibep-liga accumulation is approximately 30% at the approved recommended dosage. Absorption The median (min, max) estimated subcutaneous bioavailability of lerodalcibep-liga is 83% (66%, 89%).

The median (min, max) time to maximum plasma concentration (Tmax) is 6 days (2, 9 days) at steady state. Distribution Lerodalcibep-liga does not extensively distribute into tissues; the apparent volume of distribution is

5.3L. Elimination As a protein, lerodalcibep-liga is expected to degrade to small peptides and amino acids. Clearance of free lerodalcibep-liga (CV%) is

0.36L/day (30%) with an estimated half-life of approximately 10 days. The estimated elimination rate of lerodalcibep-liga (CV%) bound to PCSK9 is

0.47L/day (22%) which corresponds to a half-life of approximately 1.5 days. Specific Populations No clinically significant differences in the pharmacokinetics of LEROCHOL were observed based on age (21 to 78 years), body weight, sex, race, mild (eGFR 60 to 89 mL/min) or moderate (eGFR 30 to 59 mL/min) renal impairment, or mild (total bilirubin 1.0 to 1.5 upper limit of normal or aspartate aminotransaminase greater than the upper limit of normal) or moderate (total bilirubin 1.5 to 3.0 upper limit of normal) hepatic impairment.

The effect of severe renal impairment (eGFR less than 30 mL/min) or severe hepatic impairment on LEROCHOL pharmacokinetics is unknown. Drug Interaction Studies No formal clinical drug interaction studies have been performed.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of lerodalcibep-liga or of other lerodalcibep products. During the 52-week treatment period in Trial 1 and Trial 2, 15.1% (180/1,195) of LEROCHOL-treated patients at the recommended dosage with evaluable assessments were ADA positive, of whom 22.8% (41/180) had neutralizing antibodies (NAb).

During the 24-week treatment period in Trial 3, 11.3% (36/318) of LEROCHOL-treated patients at the recommended dosage with evaluable assessments were ADA positive, of whom 55.6% (20/36) had NAb [see Clinical Studies ( 14 )] . There was no identified clinically significant effect of ADA and NAb on the pharmacokinetics, pharmacodynamics (free PCSK9), safety, or effectiveness (LDL-C) of LEROCHOL over the treatment period of 52 weeks.

🧬 Mechanism of Action 67 words ▾

12.1Mechanism of Action Lerodalcibep-liga is a recombinant fusion protein that binds PCSK9 with picomolar affinity. PCSK9 binds to low-density lipoprotein receptor (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, lerodalcibep-liga increases the number of LDLRs available to clear LDL-C from the blood, thereby lowering LDL-C levels. [see Clinical Pharmacology ( 12.3 )] .

📦 How Supplied / Storage and Handling 126 words ▾

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). 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 original carton and must be used within 3 months of being removed from the refrigerator.

If not used within 3 months, discard LEROCHOL. Do not use beyond the expiration date on the container or package.

📋 Description 98 words ▾

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. 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.

💬 Information for Patients 83 words ▾

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

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Following a single subcutaneous administration, exposure to lerodalcibep-liga increased in a dose proportional manner over the dose range 75 to 300 mg of lerodalcibep-liga. Lerodalcibep-liga pharmacokinetics were observed at steady state in patients at the approved recommended dosage and are presented as mean (SD), unless otherwise specified. Lerodalcibep-liga maximum concentration (Cmax) is 31.4 (10.2) mcg/mL, and total systemic exposure (AUC0-tau) is 12,600 (5,190) (hrs*mcg/mL) following subcutaneous dose of lerodalcibep-liga 300 mg once every four weeks.

Lerodalcibep-liga steady-state is reached following 2 to 3 doses. Lerodalcibep-liga accumulation is approximately 30% at the approved recommended dosage. Absorption The median (min, max) estimated subcutaneous bioavailability of lerodalcibep-liga is 83% (66%, 89%).

The median (min, max) time to maximum plasma concentration (Tmax) is 6 days (2, 9 days) at steady state. Distribution Lerodalcibep-liga does not extensively distribute into tissues; the apparent volume of distribution is

5.3L. Elimination As a protein, lerodalcibep-liga is expected to degrade to small peptides and amino acids. Clearance of free lerodalcibep-liga (CV%) is

0.36L/day (30%) with an estimated half-life of approximately 10 days. The estimated elimination rate of lerodalcibep-liga (CV%) bound to PCSK9 is

0.47L/day (22%) which corresponds to a half-life of approximately 1.5 days. Specific Populations No clinically significant differences in the pharmacokinetics of LEROCHOL were observed based on age (21 to 78 years), body weight, sex, race, mild (eGFR 60 to 89 mL/min) or moderate (eGFR 30 to 59 mL/min) renal impairment, or mild (total bilirubin 1.0 to 1.5 upper limit of normal or aspartate aminotransaminase greater than the upper limit of normal) or moderate (total bilirubin 1.5 to 3.0 upper limit of normal) hepatic impairment.

The effect of severe renal impairment (eGFR less than 30 mL/min) or severe hepatic impairment on LEROCHOL pharmacokinetics is unknown. Drug Interaction Studies No formal clinical drug interaction studies have been performed.

🧬 Pharmacodynamics 45 words ▾

12.2Pharmacodynamics After subcutaneous administration of 300 mg lerodalcibep-liga every month, greater than 90% suppression of PCSK9 occurs within 24 hours after dosing and is maintained throughout the dosing interval, returning toward baseline during the last 7 to 10 days of the monthly dosing period.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of LEROCHOL was evaluated in three randomized, double-blind, placebo-controlled trials that enrolled 2,017 adults with HeFH, clinical ASCVD, or increased risk for ASCVD, who were on a stable low-fat, low-cholesterol diet and maximally tolerated statin therapy and who required additional LDL-C lowering. Primary Hypercholesterolemia Trial 1 (NCT04797247) and Trial 2 (NCT04806893) were both multicenter, double-blind, randomized, placebo-controlled 52-week trials in which 1,844 adults with ASCVD or at increased risk for ASCVD events were randomized 2:1 to receive subcutaneous injections of either LEROCHOL 300 mg (n=1,229) or placebo (n=615) every 4 weeks.

Patients were stable on a low-fat, low-cholesterol diet, maximally tolerated dose of statin with or without other oral lipid modifying therapy, and required additional LDL-C reduction. Baseline Disease and Demographic Characteristics The mean age in Trial 1 at baseline was 64 years (range: 25 to 90 years), 49% were 65 years or older, 30% were female, 80% were White, 17% were Black or African American, and 3% were Asian; 1.1% identified as Hispanic or Latino ethnicity. Thirty four percent (34%) of patients had diabetes at baseline, 86% established ASCVD, and 14% at increased risk for CVD events.

The mean baseline LDL-C was 102 mg/dL. At the time of randomization, 87% of patients were receiving statin therapy and of these 53% were receiving high-intensity statin therapy; 18% were receiving ezetimibe either in combination with a statin or alone. The mean age in Trial 2 at baseline was 65 years (range: 27 to 87 years), 54% were 65 years or older, 45% were female, 78% were White, 18% were Black or African American, and 4% were Asian; 13% identified as Hispanic or Latino ethnicity.

Forty-three percent (43%) of patients had diabetes at baseline, 48% established ASCVD, and 52% at increased risk for CVD events. The mean baseline LDL-C was 116 mg/dL. At the time of randomization, 83% of patients were receiving statin therapy and of these, 39% were on high-intensity doses; 17% were receiving ezetimibe either in combination with a statin or alone.

Endpoint Results The primary efficacy outcome measure in Trial 1 was the placebo adjusted intent to treat (ITT) analysis of percent change in LDL-C from baseline to Week 52. The difference between the LEROCHOL and placebo group in mean percentage change in LDL-C from baseline to Week 52 was -55% (95% CI: -59.2%, -50.8%; p < 0.0001). For additional results, see Table 3 and Figure 1 .

Table 3: Changes in Lipid Parameters in Patients with Hypercholesterolemia and ASCVD or Increased Risk for ASCVD Events on Maximally Tolerated Statin Therapy (Percent Change from Baseline to Week 52 in Trial 1) Abbreviation: ApoB = apolipoprotein B; CI = confidence interval; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; n = number of patients randomly assigned to each treatment group; LS Mean= least-squares mean a LDL-C, Total Cholesterol, non-HDL-C and ApoB at Week 52 were missing for 7.5% and 10.4% of patients assigned to placebo and LEROCHOL, respectively.

Multiple imputation washout model was implemented for imputing missing values at Week 52. b Least-squares mean from an Analysis of Covariance (ANCOVA) model including treatment as a factor and baseline value as a covariate, assuming unequal variances between groups. c p-value <0.001 for superiority, controlled for Type I error rate. d Not controlled for Type I error rate. Treatment Group LDL-C a Total Cholesterol a Non-HDL-C a ApoB a Placebo (n = 308) -0.1 -0.2 -0.7 +1 LEROCHOL 300mg (n = 614) -55 -31 -46 -39 Difference from placebo (LS Mean) (95% CI) -55 b,c (-59, -51) -31 b,d (-33, -28) -45 b,d (-48, -41) -40 b,d (-44, -37) Figure 1: Mean Percent Change from Baseline in LDL-C Over 52 Weeks in Patients with Hypercholesterolemia and ASCVD or Increased Risk for ASCVD Events on Maximally Tolerated Statin Therapy (Trial 1) The primary effica… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 106 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with lerodalcibep-liga. The mutagenic potential of lerodalcibep-liga has not been evaluated; however, proteins are not expected to directly interact with DNA or chromosomes. Fertility studies were not performed.

However, in a chronic 6-month toxicology study in sexually mature cynomolgus monkeys, no adverse lerodalcibep-liga-related effects on surrogate markers of fertility (reproductive organ histopathology, menstrual cycling, or sperm parameters) were observed when lerodalcibep-liga was administered subcutaneously at 30 and 100 mg/kg once weekly. The highest dose tested corresponds to 138-fold the recommended human dose of 300 mg every month based on serum AUC.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 103 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with lerodalcibep-liga. The mutagenic potential of lerodalcibep-liga has not been evaluated; however, proteins are not expected to directly interact with DNA or chromosomes. Fertility studies were not performed.

However, in a chronic 6-month toxicology study in sexually mature cynomolgus monkeys, no adverse lerodalcibep-liga-related effects on surrogate markers of fertility (reproductive organ histopathology, menstrual cycling, or sperm parameters) were observed when lerodalcibep-liga was administered subcutaneously at 30 and 100 mg/kg once weekly. The highest dose tested corresponds to 138-fold the recommended human dose of 300 mg every month based on serum AUC.

📄 Patient Package Insert ~3 min read ▾

This Patient Package Insert has been approved by the U.S. Food and Drug Administration. 12/2025 Patient Information LEROCHOL TM (leer-O-call) (lerodalcibep-liga) injection, for subcutaneous use What is LEROCHOL?

LEROCHOL is an injectable prescription medicine used along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol in adults with high blood cholesterol levels called hypercholesterolemia including heterozygous familial hypercholesterolemia (HeFH). It is not known if LEROCHOL is safe and effective in children. What should I tell my healthcare provider before using LEROCHOL?

Before you start using LEROCHOL, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if LEROCHOL will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking LEROCHOL. are breastfeeding or plan to breastfeed.

You and your healthcare provider should decide if you will take LEROCHOL or breastfeed. You should not do both without talking to your healthcare provider first. Tell your healthcare provider or pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use LEROCHOL? See the detailed Instructions for Use that comes with this Patient Information about the right way to prepare and give your LEROCHOL injections. Use LEROCHOL exactly as your healthcare provider tells you to use it.

LEROCHOL comes as a single-dose (1 time) prefilled syringe. If your healthcare provider decides that you or a caregiver can give the injections of LEROCHOL, you or your caregiver should receive training on the right way to prepare and give LEROCHOL. Do not try to inject LEROCHOL until you have been shown the right way by your healthcare provider or nurse.

LEROCHOL is injected under the skin (subcutaneously) 1 time every month. LEROCHOL can be self-injected in the stomach area, at least 2 inches away from the belly button or upper front of the legs (thighs). LEROCHOL can be injected by a caregiver or healthcare provider in the back of the upper arm.

Do not choose an area where the skin is tender, bruised, red, or hard. Do not inject LEROCHOL together with other injectable medicines at the same injection site. Always check the label of your syringe to make sure you have the correct medicine.

If you forget to use LEROCHOL or are not able to take the dose on your regular schedule, inject your missed dose as soon as you remember if it has been less than 7 days of the missed dose and continue the original monthly dosage schedule. If it is 7 or more days from the missed dose, inject the dose and start a new monthly schedule using the date LEROCHOL was taken. If you are not sure when to re-start LEROCHOL, ask your healthcare provider or pharmacist.

If you use more LEROCHOL than you should, talk to your healthcare provider or pharmacist. Do not stop using LEROCHOL without talking with your healthcare provider. If you stop using LEROCHOL, your cholesterol levels can increase.

What are the possible side effects of LEROCHOL? The common side effects of LEROCHOL include: redness, itching, swelling, pain, bruising or tenderness at the injection site runny or stuffy nose, sore throat (nasopharyngitis) diarrhea nausea swelling in arms, hands, legs, or feet (peripheral edema) Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088. How should I store LEROCHOL?

Store LEROCHOL in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton until ready to use and to protect from light. If needed, LEROCHOL may be kept at room temperature between 68°F to 77°F (20°C to 25°C) in the original carton for up to 3 months af… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE LEROCHOL TM [leer-O-call] (lerodalcibep-liga) injection, for subcutaneous use only Single-dose Prefilled Syringe This Instructions for Use contains information on how to inject LEROCHOL. Read and follow these instructions before you start using the LEROCHOL prefilled syringe and each time you get a refill. There may be new information.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Do not use the LEROCHOL prefilled syringe until your healthcare provider has given you instructions on the right way to give an injection. Parts of the Prefilled Syringe (see Figure A ) Figure A Important Information You Need to Know Before Injecting LEROCHOL For subcutaneous injection only (inject under the skin).

Do not use LEROCHOL if the seals on the sides of the carton have already been broken. If seals have already been broken, LEROCHOL may have been tampered with, get a new carton. Do not use LEROCHOL if the prefilled syringe is dropped or damaged.

Get a new carton. Do not re-cap the prefilled syringe as you may stick yourself or damage the needle. Do not freeze.

Safely throw away (dispose of) the used prefilled syringe after the injection is completed (see Step 15. Dispose of used prefilled syringe ). Preparing to Inject LEROCHOL Step 1.

Gather the supplies needed to give the injection. Choose a clean, flat surface in a well-lit area. Gather the following supplies and place them on the surface (see Figure B ): Carton containing prefilled syringe Items not included in the carton: Alcohol wipe Cotton ball or gauze Adhesive bandage FDA-cleared Sharps disposal container Figure B Step 2.

If refrigerated, let the prefilled syringe warm to room temperature for 30 minutes. Let the carton sit at room temperature for 30 minutes before use (see Figure C ). Keep the prefilled syringe in the carton during warm-up to protect from light.

Letting the prefilled syringe warm to room temperature will make the injection more comfortable. Do not use a heat source such as a microwave or warm the carton containing the prefilled syringe any other way. Do not shake the carton.

Figure C Step 3. Remove the plastic tray from the carton. Break the seal and open the side of the carton.

Do not use LEROCHOL if the seals on the sides of the carton have already been broken. If seals have already been broken, LEROCHOL may have been tampered with, get a new carton. Gently slide the plastic tray containing the prefilled syringe from the carton into the palm of your hand ( Figure D ).

Figure D Step 4. Remove the prefilled syringe from the plastic tray. Place the plastic tray on your hand and peel off the paper seal with your other hand (see Figure E ).

Turn the plastic tray over and gently press the middle of the tray's back to release the prefilled syringe into the palm of your hand (see Figures F , G and H ). Figure E Figure F Figure G Figure H Do not pick up or pull the prefilled syringe by the plunger rod or gray needle cap. This could damage the syringe.

Do not remove the gray needle cap from the prefilled syringe until you are ready to inject. Always hold the prefilled syringe by the syringe barrel. Step 5.

Inspect the prefilled syringe. Make sure LEROCHOL appears on the prefilled syringe label. Check the expiration (EXP) date (see Figure I ).

Check the prefilled syringe for damage. Do not use and get a new carton if LEROCHOL does not appear on the label, the expiration date has passed, or there are signs of damage. Figure I Step 6.

Inspect the medicine. Check the medicine to make sure the liquid is clear to brownish-yellow or amber (see Figure J ). Do not use the prefilled syringe if the liquid is cloudy or contains visible particles.

Get a new carton. Figure J Step 7. Wash your hands.

Wash your hands with soap and water and dry them thoroughly (see Figure K ). Figure K Step 8. Choose an injection site.

Choose an injection site from the following areas (see Figure L ):… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 163 words ▾

Principal Display Panel – 300 mg/1.2 mL Carton Label NDC: 84685-300-01 Rx Only LEROCHOL™ (lerodalcibep-liga) Injection 300 mg/1.2 mL (250 mg/mL) 1 Single-dose Prefilled Syringe 300 mg/1.2 mL (250 mg/mL) For Subcutaneous Injection Single-dose Prefilled Syringe Discard unused portion. Sterile Solution – No Preservative Keep out of the sight and reach of children LIB THERAPEUTICS Principal Display Panel – 300 mg/1.2 mL Carton Label

Principal Display Panel – 300 mg/1.2 mL Tray Label NDC: 84685-300-01 LEROCHOL™ (lerodalcibep-liga) Injection 300 mg/1.2 mL (250 mg/mL) Rx Only 1 Single-dose Prefilled Syringe 300 mg/1.2 mL (250 mg/mL) For Subcutaneous Injection Single-dose Prefilled Syringe Discard unused portion. Sterile Solution – No Preservative Principal Display Panel – 300 mg/1.2 mL Tray Label

Principal Display Panel – 300 mg/1.2 mL Prefilled Syringe Label NDC: 84685-300-01 Rx Only LEROCHOL™ (lerodalcibep-liga) Injection 300 mg/1.2 mL (250 mg/mL) For Subcutaneous Injection Single-dose Prefilled Syringe Discard unused portion. Sterile Solution – No Preservative Principal Display Panel – 300 mg/1.2 mL Prefilled Syringe Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by LIB Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
LIB Therapeutics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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Where does this data come from?
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.