HomeNDC LookupIngredientsLipfendra › 00006-5084-01
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LIPFENDRA 20 mg Tablet, Film Coated, 30-count

by Merck Sharp & Dohme LLC · 30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01)
NDC 00006-5084-01
🏷️ FDA NDC (as labeled) 0006-5084-01 billing pads the labeler segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also comes in: 7 tablets 00006-5084-59
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0006-5084-01
Product NDC 0006-5084
11-digit billing NDC 00006508401
RxCUI 2747756
UNII PSR59MCX5M
Application # NDA220848
SPL Set ID 100ec543-fbd0-44fc-b740-db9cdff39145
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance ENLICITIDE DECANOATE
Why two NDCs? The FDA registers this code as 0006-5084-01 — a 4-4-2 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 labeler segment → 00006-5084-01. 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.

🏭 Manufacturer & labeler

LabelerMerck Sharp & Dohme LLC
FDA applicationNDA220848 (NDA)
Labeler code00006
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio112 products on file
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
📖 Read our full Enlicitide Decanoate guide →
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.

💊 What it looks like

Color White
ShapeOval
Imprint119;logo
Size13 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

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

  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII U72Q2I8C85
    A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 23ZQ42JZZH
    A synthetic polymer made by chemically linking polyvinyl alcohol to polyethylene glycol. It acts as a binder and film-former to hold tablet ingredients together and create smooth coatings on capsules or tablets.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4I820XKV2A
    Sodium caprate is a salt derived from capric acid, a naturally occurring fatty acid. In medicines, it acts as a permeability enhancer to help improve absorption of drugs through the intestines.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

12 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 DailyMedingredient 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.

💲 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 eachPer 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.
Try another pack size: 7 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lipfendra 20 mgthis 00006-5084-01 Merck 30 tablets FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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 & generic status

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00006-5084-01 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) 2026-07-15 Active
00006-5084-59 1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) 2026-07-15 Active

Pack size FAQ

What quantity is in NDC 00006-5084-01?
NDC 00006-5084-01 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 00006-5084-01 and NDC 00006-5084-59?
Both are LIPFENDRA 20 mg Tablet, Film Coated — the drug itself is identical. NDC 00006-5084-01 is the 30-count package, while NDC 00006-5084-59 is the 7 tablets package.
What NDC number is used to bill for this package of LIPFENDRA 20 mg Tablet, Film Coated?
Bill NDC 00006-5084-01 — the 11-digit billing format is 00006508401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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 FDA registers it as 0006-5084-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00006-5084-01, written without dashes as 00006508401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00006-5084-01, the first segment (00006) is the labeler code FDA assigned to Merck Sharp & Dohme LLC; the middle segment (5084) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
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 Merck Sharp & Dohme LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 7 tablets (00006-5084-59). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Merck Sharp & Dohme LLC 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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 147 words

1 INDICATIONS AND USAGE LIPFENDRA ® 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). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.

LIPFENDRA 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). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy.

( 1 )

⏱️ Dosage and Administration ~1 min read

2 DOSAGE AND ADMINISTRATION The recommended dosage of LIPFENDRA is one 20 mg tablet taken orally once daily. ( 2.1 ) Take LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea. ( 2.2 ) Swallow the tablet whole. Do not split, crush, or chew the tablet. ( 2.2 ) After taking LIPFENDRA, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea. ( 2.2 )

2.1Recommended Dosage The recommended dosage of LIPFENDRA is one 20 mg tablet taken orally once daily. Assess LDL-C when clinically appropriate. The LDL-C-lowering effect of LIPFENDRA may be measured as early as 4 weeks after initiation.

2.2Important Administration Instructions Take LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea. Swallow the tablet whole. Do not split, crush, or chew the tablet.

After taking LIPFENDRA, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea [see Clinical Pharmacology (12.3) ] . LIPFENDRA can be taken with other medications [see Clinical Pharmacology (12.3) ] . If a dose is missed, take the missed dose as soon as possible, at least 30 minutes before the next food or drink (other than water, black coffee, or plain tea).

Do not take 2 doses on the same day.

💊 Dosage Forms and Strengths 39 words

3 DOSAGE FORMS AND STRENGTHS Tablets: 20 mg enlicitide, white to off-white with grey specks, oval-shaped, film-coated, debossed with “119” on one side and the corporate logo on the other side Film-Coated Tablets: 20 mg enlicitide ( 3 )

Contraindications 7 words

4 CONTRAINDICATIONS None. None. ( 4 )

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS The frequencies of adverse reactions in adults with hypercholesterolemia were similar between those treated with LIPFENDRA and those receiving placebo. The most common adverse reactions in a study of adults with HeFH treated with LIPFENDRA were diarrhea and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 Hypercholesterolemia The safety of LIPFENDRA was evaluated in Trial 1 (CORALreef Lipids, NCT05952856), a 52-week, multicenter, double-blind, randomized, placebo-controlled trial in 2,904 patients with hypercholesterolemia (including those with and without HeFH) and a history of a major atherosclerotic cardiovascular disease (ASCVD) event or increased risk for development of a first major ASCVD event [see Clinical Studies (14) ] .

In Trial 1, the frequencies of adverse reactions in adults with hypercholesterolemia were similar between those treated with LIPFENDRA and those receiving placebo. Similar proportions of LIPFENDRA-treated patients and placebo-treated patients discontinued treatment because of an adverse reaction. Adverse Reactions in Adults with HeFH The safety of LIPFENDRA was evaluated in Trial 2 (CORALreef HeFH, NCT05952869), a 52-week multicenter, double-blind, randomized, placebo-controlled trial in 303 patients with HeFH [see Clinical Studies (14) ] .

In Trial 2, the most common adverse reactions in adults with HeFH treated with LIPFENDRA that occurred at higher frequencies compared to placebo were diarrhea (LIPFENDRA 7%, placebo 2%) and dizziness (LIPFENDRA 9%, placebo 4%). Similar proportions of LIPFENDRA-treated patients and placebo-treated patients discontinued treatment because of an adverse reaction. The safety profile observed in adults with HeFH in Trial 2 was otherwise generally consistent with that observed in adults with hypercholesterolemia in Trial 1.

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Discontinue LIPFENDRA when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Alternatively, consider the ongoing therapeutic needs of the individual patient. Enlicitide 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, LIPFENDRA may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] .

There are insufficient data on the use of LIPFENDRA in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Consider the benefits and risks of LIPFENDRA when prescribing LIPFENDRA to pregnant women. In animal reproduction studies, no adverse embryofetal developmental effects were observed in pregnant rats and rabbits administered enlicitide subcutaneously during organogenesis (up to 58- and 51-fold, respectively, the human exposure at the recommended human dose (RHD), based on AUC) (see Data ) .

The estimated 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 the embryofetal developmental rat toxicity study, pregnant rats were administered enlicitide subcutaneously at 0.5, 3, or 10 mg/kg/day during the period of organogenesis (Gestational Days (GD) 6 through 17).

No adverse embryofetal or maternal effects were observed up to 10 mg/kg/day (58-fold the human exposure at the RHD, based on AUC). In the embryofetal developmental rabbit toxicity study, pregnant rabbits were administered enlicitide subcutaneously at 0.2, 0.5, or 3 mg/kg/day during the period of organogenesis (GD7 through 19). No adverse embryofetal or maternal effects were observed up to 3 mg/kg/day (51-fold the human exposure at the RHD, based on AUC).

In the rat pre- and postnatal developmental toxicity study, enlicitide was administered subcutaneously at 0.5, 3, or 10 mg/kg/day daily from GD 6 through lactation day (LD) 20. No adverse developmental or maternal effects were observed up to 10 mg/kg/day (58-fold the human exposure at the RHD, based on AUC). Enlicitide crosses the placenta and was detected in rat fetal plasma at concentrations that were 3 to 5% of mean maternal plasma concentrations.

8.2Lactation Risk Summary There is no information on the presence of enlicitide in human milk, the effects on the breastfed infant, or the effects on milk production. Enlicitide was detected at low concentrations in the plasma of nursing pups from lactating rats administered subcutaneous enlicitide (see Data ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIPFENDRA and any potential adverse effects on the breastfed child from LIPFENDRA or from the underlying maternal condition [see Clinical Pharmacology (12.1) ] .

Data Animal Data Enlicitide was detected in the plasma of nursing pups (LD 7) from lactating rats administered enlicitide subcutaneously at 0.5, 3, and 10 mg/kg/day from GD 6 to LD 7, with the majority of individual pup-to-maternal plasma concentrations ≤0.7% across doses.

8.4Pediatric Use The safety and effectiveness of LIPFENDRA have not been established in pediatric patients.

8.5Geriatric Use Of the 2,137 patients treated with LIPFENDRA in placebo-controlled trials, 960 (45%) patients were 65 years of age and older, and 252 (12%) patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary Discontinue LIPFENDRA when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Alternatively, consider the ongoing therapeutic needs of the individual patient. Enlicitide 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, LIPFENDRA may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] .

There are insufficient data on the use of LIPFENDRA in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Consider the benefits and risks of LIPFENDRA when prescribing LIPFENDRA to pregnant women. In animal reproduction studies, no adverse embryofetal developmental effects were observed in pregnant rats and rabbits administered enlicitide subcutaneously during organogenesis (up to 58- and 51-fold, respectively, the human exposure at the recommended human dose (RHD), based on AUC) (see Data ) .

The estimated 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 the embryofetal developmental rat toxicity study, pregnant rats were administered enlicitide subcutaneously at 0.5, 3, or 10 mg/kg/day during the period of organogenesis (Gestational Days (GD) 6 through 17).

No adverse embryofetal or maternal effects were observed up to 10 mg/kg/day (58-fold the human exposure at the RHD, based on AUC). In the embryofetal developmental rabbit toxicity study, pregnant rabbits were administered enlicitide subcutaneously at 0.2, 0.5, or 3 mg/kg/day during the period of organogenesis (GD7 through 19). No adverse embryofetal or maternal effects were observed up to 3 mg/kg/day (51-fold the human exposure at the RHD, based on AUC).

In the rat pre- and postnatal developmental toxicity study, enlicitide was administered subcutaneously at 0.5, 3, or 10 mg/kg/day daily from GD 6 through lactation day (LD) 20. No adverse developmental or maternal effects were observed up to 10 mg/kg/day (58-fold the human exposure at the RHD, based on AUC). Enlicitide crosses the placenta and was detected in rat fetal plasma at concentrations that were 3 to 5% of mean maternal plasma concentrations.

🧒 Pediatric Use 16 words

8.4Pediatric Use The safety and effectiveness of LIPFENDRA have not been established in pediatric patients.

🧓 Geriatric Use 55 words

8.5Geriatric Use Of the 2,137 patients treated with LIPFENDRA in placebo-controlled trials, 960 (45%) patients were 65 years of age and older, and 252 (12%) patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.

🆘 Overdosage 35 words

10 OVERDOSAGE There is no specific treatment for overdose with LIPFENDRA. In the event of an overdose of LIPFENDRA, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Enlicitide is a macrocyclic peptide that binds to PCSK9. PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, enlicitide increases the number of LDLRs available to clear LDL-C, thereby lowering LDL-C levels.

12.2Pharmacodynamics Administration of single doses of enlicitide ≥10 mg results in a maximum reduction in plasma levels of free PCSK9 >90% at T max for enlicitide (0.5–1 hour postdose). Exposure–response analysis across enlicitide daily doses ranging from 0.5 times to 1.5 times the recommended dose demonstrated that the 20 mg dose achieved near-maximal reductions in plasma LDL-C in participants with hypercholesterolemia. Cardiac Electrophysiology At four times that of the clinical C max at the maximum recommended enlicitide dose, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics The geometric means (% coefficient of variation) of steady-state enlicitide AUC and C max following once daily enlicitide 20 mg were 308 nM•h (28%) and 15.5 nM (29%), respectively, in participants with hypercholesterolemia. Enlicitide plasma exposures were less than dose-proportional between 0.25 times and 15 times the recommended dosage of 20 mg. Steady-state is achieved by approximately 7 days with an accumulation ratio of 1.42.

Absorption Each LIPFENDRA tablet contains sodium caprate, which facilitates the oral absorption of enlicitide. The oral bioavailability of enlicitide is approximately 1%. When LIPFENDRA is orally administered on an empty stomach in the morning with a meal given at least 30 minutes after the enlicitide dose, enlicitide is rapidly absorbed with a T max of approximately 0.5–1 hour.

Effect of Food LIPFENDRA administration on an empty stomach in the morning, at least 30 minutes before a meal, does not affect the exposure of enlicitide. LIPFENDRA administration 30 minutes after a meal reduces steady-state AUC and C max by 48% and 50%, respectively, and delays T max . Effect of Beverages The administration of LIPFENDRA with black coffee or plain tea does not result in a clinically meaningful change in enlicitide exposure.

Distribution The apparent steady-state volume of distribution of enlicitide is 2,384 L. Enlicitide exhibits concentration dependent plasma protein binding, ranging from 93% bound at 2 nM to 32% bound at 1 µM. Enlicitide blood to plasma ratio is approximately 0.6.

Elimination The steady-state apparent clearance in participants with hypercholesterolemia is approximately 41 L/h at the 20 mg once daily dose. Enlicitide clearance increases with increasing concentration, resulting in non-linear pharmacokinetics (PK). Enlicitide has an effective half-life of approximately 14 hours and a terminal half-life of approximately 244 hours.

Metabolism Enlicitide is minimally metabolized. No major metabolites of enlicitide have been identified. Excretion Enlicitide is primarily eliminated via glomerular filtration following IV administration, with approximately 73% and 8% of the dose excreted in urine and feces, respectively.

Specific Populations Age, Sex, and Race/Ethnicity There is no clinically meaningful effect of age (18 to 88 years), body weight (40 to 174 kg), sex, race (American Indian or Alaskan Native, Asian, Black or African American, White, or multi-racial), or ethnicity (Hispanic or Latino) on the PK of enlicitide. Patients with Renal Impairment Patients with mild (eGFR 60 to 89 mL/min), moderate (eGFR 30 to 59 mL/min), and severe renal impairment (eGFR less than 30 mL/min) are expected to have 5%, 11%, and 26% higher enlicitide steady-state exposure compared to patients with normal renal function.

These increases in exposure are not clinically meaningful. Compared to participants with normal renal function, single dose enlicitide exposure (AUC 0-inf ) was 17% and 75% higher in participants with end-…

🧬 Mechanism of Action 55 words

12.1Mechanism of Action Enlicitide is a macrocyclic peptide that binds to PCSK9. PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, enlicitide increases the number of LDLRs available to clear LDL-C, thereby lowering LDL-C levels.

📦 How Supplied / Storage and Handling 95 words

16 HOW SUPPLIED/STORAGE AND HANDLING Each LIPFENDRA film-coated tablet contains 20 mg of enlicitide, is white to off-white with grey specks, oval-shaped, and debossed with “119” on one side and the corporate logo on the other side. Each bottle contains 30 tablets (NDC 0006-5084-01) with desiccant and child-resistant closure. Store LIPFENDRA at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store and dispense LIPFENDRA in the original bottle and keep the bottle tightly closed to protect from moisture. Do not remove the desiccant.

📋 Description 176 words

11 DESCRIPTION LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11 S ,17 S ,20 S ,23 S ,27 S ,39 S ,42 S ,63 S ,66 R )-47-Fluoro-20-[(1 R )-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.2 3,6 .1 24,42 .1 33,37 .1 44,51 .0 11,15 .0 23,27 .0 45,50 ]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)- N , N , N -trimethyl-6-oxohexan-1-aminium decanoate.

Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C 92 H 129 FN 14 O 17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is: LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate.

The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent. Chemical Structure of enlicitide.jpg

💬 Information for Patients 145 words

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Dosage and Administration Instruct patients to take their dose of LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea and to wait at least 30 minutes before their next food or beverage (other than water, black coffee, or plain tea). Each tablet should be swallowed whole [see Dosage and Administration (2.2) ] .

LIPFENDRA can be taken with other medications [see Clinical Pharmacology (12.3) ] . Missed Doses Advise the patient that if a dose is missed, they should take the missed dose as soon as possible, at least 30 minutes before the next food or drink (other than water, black coffee, or plain tea). They should not take 2 doses on the same day [see Dosage and Administration (2.2) ] .

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