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Lerodalcibep-Liga

Lerodalcibep-liga is a PCSK9 inhibitor used alongside diet and exercise to lower LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

Brand name Lerochol
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 31, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Lerodalcibep-Liga at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Lerodalcibep-liga (Lerochol) is a once-monthly injection, used alongside diet and exercise, that lowers LDL (“bad”) cholesterol by blocking PCSK9, a protein that destroys the liver’s LDL-clearing receptors, so more LDL leaves the blood. New to the U.S. market around 2025, it is, like other PCSK9 inhibitors, usually an add-on when a statin falls short or is not tolerated. Most people tolerate it well, and what they notice is redness, swelling or soreness where the shot went in, or cold-like symptoms. The one thing to look for is pregnancy, since lowering cholesterol may harm a developing baby, so it should be stopped once pregnancy is recognized.

Clinical pearls

  • It is also approved for heterozygous familial hypercholesterolemia (HeFH), an inherited condition causing very high cholesterol from birth.
  • Use the abdomen or upper front thighs, and save the back of the upper arm for when someone else injects.
  • Its effects in severe kidney or liver disease are not fully known, so that history matters before the first dose.
  • New or worsening swelling in the legs or feet is a listed side effect worth reporting rather than ignoring.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record2025
Companies listing it with the FDA1
FDA label last updatedJul 28, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Lerodalcibep-Liga, written from its FDA label.

What Lerodalcibep-Liga is used for

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Lerodalcibep-liga is used to lower LDL cholesterol in adults when diet and exercise alone are not enough.

  • Lerochol is indicated as an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia (high cholesterol), including those with heterozygous familial hypercholesterolemia (HeFH) — an inherited condition that causes significantly elevated cholesterol levels from a young age.

How Lerodalcibep-Liga works

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Lerodalcibep-liga is a lab-engineered fusion protein that tightly binds to a protein called PCSK9. Under normal circumstances, PCSK9 tags the LDL receptors on liver cells for destruction — and fewer receptors means less LDL cholesterol gets cleared from the blood. By blocking PCSK9, lerodalcibep-liga preserves those receptors so they can keep pulling LDL cholesterol out of circulation, leading to lower LDL levels in the blood.

After a monthly subcutaneous dose, the drug suppresses more than 90% of PCSK9 activity within 24 hours. This suppression is maintained throughout most of the monthly dosing period, with levels beginning to return toward baseline in the last week or so before the next dose.

Lerodalcibep-Liga dosage

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Lerochol is given as a once-monthly subcutaneous injection (a shot just under the skin). It does not need to be taken with food. Your doctor may check your LDL cholesterol as early as 4 weeks after you start to see how it's working.

  • If you miss a dose by fewer than 7 days, inject as soon as possible and continue on your original monthly schedule.
  • If you miss a dose by 7 or more days, inject as soon as possible and start a new monthly schedule from that date.
  • Always follow the Instructions for Use provided with Lerochol and the guidance of your prescriber.

Dosing details from the FDA-approved label

From the Lerodalcibep-Liga prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage (LEROCHOL)
    • 300 mg administered subcutaneously once monthly
  • Missed dose: less than 7 days
    • Administer LEROCHOL as soon as possible and resume the original monthly dosage schedule
  • Missed dose: seven (7) or more days
    • Administer LEROCHOL as soon as possible and start a new monthly dosage schedule based on this date
Read the label’s full dosing text

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.

Read the full Dosage and Administration section on DailyMed →

Lerodalcibep-Liga side effects

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The most common side effects seen with Lerochol in clinical trials include:

Common side effects

  • Injection site reactions (redness, swelling, or pain where the shot was given)
  • Nasopharyngitis (common cold-like symptoms)
  • Diarrhea
  • Nausea
  • Peripheral edema (swelling in the hands, feet, or legs)
  • Injection site reactions — redness, pain, swelling, or bruising at the injection site
  • Nasopharyngitis — runny nose, sore throat, and other cold-like symptoms
  • Peripheral edema — swelling in the hands, feet, or lower legs

When to get medical help

  • Tell your doctor if injection site reactions are severe, persist, or worsen
  • Contact your doctor if swelling in your legs or feet is new or getting worse
  • Let your doctor know right away if you think you may be pregnant — Lerochol should be stopped when pregnancy is recognized

Injection site reactions were the most common reason people stopped treatment in clinical trials. Contact your doctor if reactions at the injection site are severe or do not improve, or if you develop significant swelling in your legs or feet.

Lerodalcibep-Liga warnings and precautions

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  • Pregnancy: Lerochol lowers cholesterol, which is needed for fetal development, and may harm a developing baby. Stop Lerochol when pregnancy is recognized unless your doctor determines the ongoing benefit outweighs the risk. High cholesterol treatment is generally not necessary during pregnancy, and pausing therapy is unlikely to affect your long-term outcomes.
  • Breastfeeding: It is not known whether Lerochol passes into human milk in significant amounts. Animal studies found low levels in milk. Discuss breastfeeding with your doctor before continuing Lerochol while nursing.
  • Severe kidney or liver disease: The effect of Lerochol in people with severe kidney or liver impairment is not known. Tell your doctor if you have serious kidney or liver problems.
  • Children: Lerochol's safety and effectiveness have not been established in children. It is not approved for pediatric use.

Lerodalcibep-Liga interactions

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No formal drug interaction studies have been performed with lerodalcibep-liga. Talk to your doctor or pharmacist about all medications, supplements, and herbal products you take.

  • No specific drug, food, or supplement interactions are currently identified in the prescribing information — but always inform your healthcare team of everything you are taking.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Lerodalcibep-Liga against a supplement or herb →

Before taking Lerodalcibep-Liga

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  • Pregnancy: Tell your doctor immediately if you are pregnant, think you might be pregnant, or are planning to become pregnant. Lerochol should generally be stopped during pregnancy.
  • Breastfeeding: Talk to your doctor before breastfeeding while on Lerochol — the safety for nursing infants is not established.
  • Children: Lerochol is not approved for use in children. Its effectiveness was not demonstrated in a study in pediatric patients with homozygous familial hypercholesterolemia.
  • Severe kidney disease: The impact of Lerochol in patients with severe kidney impairment (eGFR below 30) is unknown — tell your doctor if this applies to you.
  • Severe liver disease: Lerochol has not been studied in patients with severe hepatic impairment — let your doctor know if you have serious liver problems.
  • Older adults: Adults 65 and older used Lerochol safely in clinical trials with no significant differences in safety or effectiveness compared to younger adults.

What Lerodalcibep-Liga does in the body

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After a monthly subcutaneous dose of Lerochol, more than 90% suppression of PCSK9 occurs within the first 24 hours. This high level of suppression is sustained throughout most of the monthly dosing period, only beginning to drift back toward baseline in the final 7 to 10 days before the next injection. This sustained blocking of PCSK9 keeps LDL receptors active on liver cells, resulting in meaningfully lower LDL cholesterol levels in the blood.

How your body processes Lerodalcibep-Liga

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After a subcutaneous injection, Lerochol is absorbed with about 83% bioavailability, reaching peak blood levels around 6 days after the dose. The drug reaches steady-state concentrations after 2 to 3 monthly doses, with roughly 30% accumulation at the recommended dosing schedule. As a protein, lerodalcibep-liga is broken down into small peptides and amino acids — the free (unbound) form has an estimated half-life of about 10 days, while the portion bound to PCSK9 clears more quickly, with a half-life of about 1.5 days. No clinically significant differences in how the body handles Lerochol were found based on age, sex, body weight, race, or mild-to-moderate kidney or liver impairment.

How to store Lerodalcibep-Liga

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Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. refrigerator.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Lerodalcibep-Liga: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Lerodalcibep-Liga — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does Lerochol do, and why do I need a shot instead of a pill?

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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 PCSK9, Lerochol keeps those receptors working so your liver can clear more cholesterol. It's given as an injection under the skin because, as a protein-based medicine, it would be broken down in your stomach if you swallowed it — just like how insulin has to be injected.

How often do I have to take this, and where do I inject it?

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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 back of your upper arm works too. Rotate spots each time so the same area doesn't get irritated. Let the syringe warm up at room temperature for at least 30 minutes if it's been in the refrigerator before injecting.

What side effects should I expect, and which ones should make me call my doctor?

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The most common side effects are reactions at the injection site — like redness, soreness, or swelling where you give the shot — along with cold-like symptoms, diarrhea, nausea, and some swelling in your hands or feet. Most of these are mild. You should call your doctor if the injection site reactions are severe or not getting better, or if you notice significant new swelling in your legs or feet. These could need attention.

I'm a woman of childbearing age — is Lerochol safe if I get pregnant?

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This is an important one to talk through with your doctor. Lerochol lowers cholesterol, which the developing baby actually needs — so there's concern it could be harmful during pregnancy. The guidance is to stop Lerochol when pregnancy is recognized. Since treating high cholesterol is generally not urgent during pregnancy, pausing shouldn't hurt your long-term health. If you're breastfeeding, the data isn't fully clear either, so discuss that with your doctor too before continuing the medication.

Will this interact with my other medications?

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No formal drug interaction studies have been done with Lerochol yet, so we don't have a specific list of interactions to warn you about. That said, always share a full list of your medications, vitamins, and supplements with your doctor and pharmacist whenever you start something new — that way they can keep an eye out for any potential concerns.

How long before I see my cholesterol numbers improve?

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Your doctor can check your LDL cholesterol as early as 4 weeks after you start Lerochol, and you should start to see meaningful changes by then. The drug reaches its steady working level in your body after 2 to 3 monthly doses. Keep in mind that Lerochol works best when combined with a heart-healthy diet and regular exercise — it's a team effort.

Is Lerodalcibep-Liga available over the counter?

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No. Lerodalcibep-Liga is a prescription medicine: every Lerodalcibep-Liga product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Lerodalcibep-Liga first available?

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The earliest FDA record we hold for Lerodalcibep-Liga is from 2025: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Lerodalcibep-Liga was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Lerodalcibep-Liga on HelloPharmacist

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Detailed data & references for Lerodalcibep-Liga Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Lerodalcibep-Liga forms and strengths (how it comes)

Lerodalcibep-Liga is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Lerodalcibep-Liga inactive ingredients by manufacturer.

Injection

By injection · Under the skin
Brands Lerochol
How this form is used
What it may be used for
  • Lerochol is used to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), alongside diet and exercise
Important instructions
  • Lerochol is injected subcutaneously (under the skin) once monthly into the abdomen or upper front thighs; a caregiver or healthcare professional may also use the back of the upper arm
  • Lerochol should be allowed to warm to room temperature for at least 30 minutes before injecting if it has been refrigerated
  • Lerochol solution should be clear to slightly opalescent and brownish-yellow to amber — do not use if it appears cloudy or contains particles
  • Lerochol injection sites should be rotated with each dose, and injections should not be given into skin that is tender, bruised, red, or hardened
Available strengths 1 strength
300 mg/1.2 mL
3 FDA-listed product records ⓘ

Lerodalcibep-Liga on the U.S. market: products, makers and brands

How Lerodalcibep-Liga appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 1 Lerodalcibep-Liga product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2025. Brand names on the directory include Lerochol; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2025
Earliest FDA record ⓘ

Compare Lerodalcibep-Liga products

A representative set of FDA-listed product records for Lerodalcibep-Liga — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
300 mg/1.2 mL Subcutaneous LIB Therapeutics, Inc. BLA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Lerodalcibep-Liga NDCs →

Lerodalcibep-Liga recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Lerodalcibep-Liga recalls since July 2021.

✅No Lerodalcibep-Liga recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lerodalcibep-Liga RxCUI 2729426 1 dose form · 1 strength

Look up RxCUI 2729426 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Lerodalcibep-Liga brand names

Lerodalcibep-Liga is sold under one brand name in the FDA directory — Lerochol. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lerochol

Who makes Lerodalcibep-Liga: manufacturers and labelers

One company lists Lerodalcibep-Liga products with the FDA. By number of product records, the largest are LIB Therapeutics, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

LIB Therapeutics, Inc. 1

Lerodalcibep-Liga drug class (RxNorm)

Lerodalcibep-Liga belongs to the Other lipid modifying agents class.

Drug family (ATC) Other lipid modifying agents

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Lerodalcibep-Liga page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 28, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lerodalcibep-Liga.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lerodalcibep-Liga after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
LIB Therapeutics, Inc.
Linked label effective
Jul 28, 2026
Composite sections available
19
Linked SPL Set ID
422f8b04-6ce8-4e64-a0a9-0ccc9a4a5860
Linked SPL Document ID
5d5134f8-4b97-4e65-a18a-654744214b53
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. LIB Therapeutics, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →