Inclisiran injection
Inclisiran is an injectable cholesterol-lowering medicine used to reduce LDL (bad) cholesterol in adults and adolescents with high cholesterol or inherited cholesterol disorders.
🧬 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 →
📖 Inclisiran injection: Patient Information Guide
A plain-language walkthrough of Inclisiran injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Inclisiran (brand name Leqvio) is a cholesterol-lowering injection approved for the following uses:
- Leqvio is used in adults with high cholesterol (hypercholesterolemia) as an add-on to diet and exercise
- Leqvio is used in adults and adolescents aged 12 and older with heterozygous familial hypercholesterolemia (HeFH — an inherited condition causing high LDL cholesterol from birth)
- Leqvio is used in adolescents aged 12 and older with homozygous familial hypercholesterolemia (HoFH — a more severe inherited form of high cholesterol)
- Clinical trials show that lowering LDL-C reduces the risk of major cardiovascular events (heart attacks, strokes) in adults at increased cardiovascular risk
⚙️How it works▾
Inclisiran is a small interfering RNA (siRNA) — a cutting-edge type of medicine that works at the genetic level inside your liver cells. It targets and breaks down the mRNA (the molecular instructions) used to produce PCSK9, a protein that normally reduces the number of LDL receptors on liver cells. When PCSK9 levels drop, the liver can recycle and express more LDL receptors on its surface. More receptors means the liver pulls more LDL (bad) cholesterol out of the blood, lowering circulating LDL-C levels.
Because inclisiran works by silencing a gene-level process deep inside liver cells, its cholesterol-lowering effects last for months from a single dose — which is why it only needs to be given twice a year after the initial loading period.
💊How it's taken▾
Leqvio is given as a subcutaneous injection (under the skin) by a healthcare professional — not self-administered at home. It can be injected into the abdomen, upper arm, or thigh. There is no food restriction associated with the injection.
- First dose on Day 1, second dose at 3 months, then every 6 months
- If you miss a dose by less than 3 months, get it as soon as possible and continue on your original schedule
- If you miss a dose by more than 3 months, your provider will restart the schedule from the beginning
- Your LDL-C can be checked as early as 30 days after starting, and at any time — you don't need to time it around your dose
🤒Side effects — in detail▾
Most people tolerate Leqvio well. The most common side effects reported in clinical trials include:
- Injection site reactions — pain, redness, or rash where the shot was given
- Joint pain (arthralgia)
- Bronchitis
- Headache (reported more in adolescents with HeFH)
Serious allergic reactions including anaphylaxis (a severe, life-threatening reaction) and angioedema (swelling under the skin) have been reported after Leqvio injections — seek emergency care immediately if you develop hives, swelling of the face or throat, or difficulty breathing.
⚠️Warnings & precautions▾
- Serious allergic reactions: Anaphylaxis and angioedema have occurred with Leqvio. Know the signs — hives, swelling of the face or throat, trouble breathing, dizziness — and get emergency help right away if they appear.
- Pregnancy: Leqvio may harm a developing baby by lowering cholesterol, which the fetus needs for normal development. Stop Leqvio if you become pregnant, or talk to your doctor about your options. Treating high cholesterol is generally not urgent during pregnancy.
- Breastfeeding: It is unknown whether inclisiran passes into human breast milk in amounts that could affect a nursing infant. Discuss the risks and benefits with your doctor.
- Severe liver disease: Leqvio has not been studied in patients with severe hepatic impairment and should be used with caution in those with moderate liver disease.
🔀What it interacts with▾
Inclisiran has a very low potential for drug interactions. Here's what the evidence shows:
- CYP450 enzymes and drug transporters: Inclisiran is not processed by or does not interfere with the enzymes (CYP450) that metabolize most common medications, so it is unlikely to cause meaningful interactions with those drugs
- Statins (atorvastatin, rosuvastatin): Studies found no clinically significant effect of inclisiran on blood levels of these common cholesterol medicines — they can be used together safely
- No formal drug interaction studies have been performed, but inclisiran is not expected to cause or be affected by drug interactions based on its mechanism
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Prior serious allergic reaction to inclisiran: Leqvio is contraindicated — do not use it if you've had anaphylaxis or angioedema from this drug or any of its ingredients
- Pregnancy: Tell your doctor immediately if you are pregnant or become pregnant; Leqvio should generally be stopped
- Breastfeeding: Talk to your doctor; the effect on nursing infants is not known
- Children under 12: Safety and effectiveness have not been established for patients younger than 12 years of age
- Kidney disease: No dose adjustment is needed for mild, moderate, or severe kidney impairment, but Leqvio has not been studied in end-stage renal disease — tell your doctor about your kidney function
- Liver disease: No dose adjustment needed for mild to moderate hepatic impairment; not studied in severe hepatic impairment — tell your doctor if you have liver problems
- Older adults (65+): No difference in safety or effectiveness compared to younger adults; no special precautions needed based on age alone
📡Pharmacodynamics — effects in the body▾
After a Leqvio injection, LDL cholesterol levels begin to fall within about 14 days. Mean LDL-C reductions of 38% to 51% have been observed between 30 and 180 days after a single dose, with levels still reduced by about 53% at Day 180. In clinical trials using the full dosing schedule, Leqvio reduced not just LDL-C, but also total cholesterol, ApoB (another marker of cardiovascular risk), and non-HDL cholesterol. At therapeutic doses, Leqvio does not affect heart electrical rhythm in any clinically meaningful way.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection of Leqvio, blood levels peak in about 4 hours, then fall to undetectable within 24 to 48 hours — but the drug's cholesterol-lowering effect lasts for months because it has already done its work inside liver cells. The drug is about 87% protein-bound in the bloodstream and is broken down primarily by nucleases (enzymes that chop up nucleic acids) — not by the liver's CYP450 enzyme system. The plasma half-life is approximately 9 hours, and the drug does not build up in the blood with repeated dosing. About 16% is cleared through the kidneys. Age, sex, race, and body weight do not significantly affect how the body handles inclisiran.
📦How to store it▾
Store LEQVIO at controlled room temperature 20°C to 25°C (68°F to 77°F) with allowable excursions between 15°C and 30°C (59°F and 86°F) .
📄 Written from Inclisiran injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Inclisiran injection — the kind of thing our pharmacy team would talk through with you at the counter.
How often do I need to come in for my Leqvio shot? ▾
What happens if I miss one of my scheduled injections? ▾
What side effects should I actually expect from this injection? ▾
Are there any serious reactions I should watch out for? ▾
Can I take Leqvio along with my statin or other cholesterol medicines? ▾
Is Leqvio safe to use during pregnancy? ▾
Is Inclisiran injection available over the counter? ▾
When was Inclisiran injection first available? ▾
💬 Answers drafted from Inclisiran injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Inclisiran injection comes
Inclisiran injection 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.
Injection
How this form is used
- Leqvio is used to lower LDL cholesterol in adults with high cholesterol (hypercholesterolemia) as an adjunct to diet and exercise
- Leqvio is used in adults and adolescents aged 12 and older with heterozygous familial hypercholesterolemia (HeFH)
- Leqvio is used in adolescents aged 12 and older with homozygous familial hypercholesterolemia (HoFH)
- Leqvio is administered by a healthcare professional as a subcutaneous injection into the abdomen, upper arm, or thigh
- Leqvio is given as an initial dose, a second dose at 3 months, then every 6 months thereafter
- Leqvio should not be injected into skin that is sunburned, irritated, infected, or has a rash
- Leqvio should be inspected before use — it should appear clear and colorless to pale yellow; do not use if it looks cloudy or contains particles
📊 Inclisiran injection across the U.S. market
How Inclisiran injection 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.
📈 How widely Inclisiran injection is used
A general measure of how commonly Inclisiran injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Inclisiran injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Inclisiran injection prescribed? Of the 1,596 medications we measure, Inclisiran injection ranks #1,135 by Medicaid prescriptions — more than 29% of them.
Utilization by Inclisiran injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1.5 ML inclisiran 189 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2588263
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Inclisiran injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Inclisiran injection NDCs with Medicaid activity.
🔍 Compare Inclisiran injection products
A representative set of FDA-listed product records for Inclisiran injection — 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 | ||||
| 284 mg/1.5 mL | Subcutaneous | Novartis Pharmaceuticals Corporation × 4 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Inclisiran injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Inclisiran injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Inclisiran injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Inclisiran injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 2588243 1 dose form · 1 strength
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Dose form (SCDF) Prefilled Syringe RxCUI 2588262No current FDA listingClinical drug / strength (SCD) 1.5 ML inclisiran 189 MG/MLRxCUI 2588263
Look up RxCUI 2588243 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.
📦 Supply & shortage status
Whether Inclisiran injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Inclisiran injection belongs to the Other lipid modifying agents class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.