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Lynavoy Linerixibat 40 mg Tablet, Film Coated, 60-count — NDC 69516-0140-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lynavoy Linerixibat 40 mg Tablet, Film Coated, 60-count — NDC 69516-140-60 (Billing 69516-0140-60)

by Intercept Pharmaceuticals Inc · 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 60 tablets of Lynavoy Linerixibat 40 mg Tablet, Film Coated from Intercept Pharmaceuticals Inc, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 69516-0140-60
🏷️ FDA NDC (as labeled) 69516-140-60 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69516-140-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69516 labeler · 140 product · 60 package
Package marketed since
Jun 11, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
60 EA per package
Barcode (UPC)
0369516140601
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69516-140-60
Product NDC 69516-140
11-digit billing NDC 69516014060
NCPDP billing unit EA — each (per item)
RxCUI 2745144, 2745150
UNII 386012Z45S
UPC 0369516140601
Application # NDA220295
SPL Set ID c00317c8-709c-4707-a6d1-632bff123026
Established class (EPC) Ileal Bile Acid Transporter Inhibitor
Mechanism of action Ileal Bile Acid Transporter Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-11
Route ORAL
Dosage form TABLET, FILM COATED
Substance LINERIXIBAT

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

GCN Seq No 088799
GCN 58969
HICL code 051238
Ingredient (HICL) Linerixibat
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7F
Therapeutic class — specific (HIC3) Ileal Bile Acid Transporter (Ibat) Inhibitor
AHFS code 56:14.00.00
AHFS class Cholelitholytic Agents
FDB label name LYNAVOY 40 MG TABLET
FDB brand name Lynavoy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088799
  • GCN: 58969
  • HICL (First Databank): 051238
  • AHFS class code: 56:14.00.00
  • RxCUI (RxNorm): 2745144
Why two NDCs? The FDA registers this code as 69516-140-60 — 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 → 69516-0140-60. 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 Ileal Bile Acid Transporter Inhibitor class.

Pharmacologic class Ileal Bile Acid Transporter Inhibitor
Drug family (ATC) Other drugs for bile therapy
How it works Ileal Bile Acid Transporter Inhibitors
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 LYNAVOY 40 MG TABLET Ingredient Linerixibat
📗 Our plain-language guide HelloPharmacist
  • It treats the itching that comes with primary biliary cholangitis (PBC) in adults. The brand name is Lynavoy. It is not recommended if you have decompensated cirrhosis or have had...
  • Swallow the tablet whole, twice a day, at least 30 minutes before any food or drink other than water. If you also take a bile acid binding resin, take Lynavoy at least 4 hours befo...
  • Take it as soon as you remember, at least 30 minutes before your next meal, then go back to your usual schedule. If more than 6 hours have passed, skip it. Never take a double dose...
  • What happens if I miss a dose of Lynavoy?
📖 Read our full Linerixibat 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 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.
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
69516-0140-60 You're viewing this Main listing 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2026-06-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lynavoy 40 mgthis 69516-0140-60 Intercept 60 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
First FDA approval
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 17, 2026 RLD RS ⏳ ~6.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9040518 — drug substance
Exclusivity NCE
Exclusivity ODE-517
2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 9040518 ↗ Drug substance — Sep 6, 2031
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Mar 17, 2031
ODE-517Orphan Drug Exclusivity (7-year)Mar 17, 2033
Common questions
Is there a generic version of LYNAVOY 40 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LYNAVOY 40 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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 Linerixibat 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerIntercept Pharmaceuticals Inc
Application holderINTERCEPT PHARMACEUTICALS INC
FDA applicationNDA220295 (NDA)
Labeler code69516
First marketedJun 2026
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 ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 119 words ▾

1 INDICATIONS AND USAGE LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . LYNAVOY is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.

( 1 ) Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy). ( 1 )

⏱️ Dosage and Administration 167 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of LYNAVOY is 40 mg taken orally twice daily. Swallow tablets whole at least 30 minutes before any food or beverage (other than water). ( 2.1 )

2.1Recommended Dosage The recommended dosage of LYNAVOY is 40 mg orally twice daily. Swallow tablets whole at least 30 minutes before any food or beverage (other than water) [see Clinical Pharmacology (12.3) ] . If a dose is missed, take the missed dose as soon as possible and at least 30 minutes before your next meal, then resume the original dosing schedule.

If a dose is missed by more than 6 hours, skip the dose and resume the original dosing schedule. Do not take a double dose to make up for a missed dose.

2.2Administration Modification for Concomitant Use with Bile Acid Binding Resins Administer LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] .

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 40 mg of linerixibat, purple, biconvex, round, film-coated tablets debossed with "GS 3JG" on one side. Tablets: 40 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Liver Test Elevations: Obtain baseline liver tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin [TB], direct bilirubin [DB], alkaline phosphatase [ALP]) and monitor the levels per standard clinical practice during treatment. If new liver test elevations occur, monitor ALT, AST, TB, DB, and ALP more frequently. For persistent liver test elevations, discontinue LYNAVOY.

( 5.1 ) Diarrhea: Diarrhea may occur. Advise patient to monitor for dehydration. Treatment interruption or discontinuation may be required if diarrhea persists.

( 5.2 ) Fat-Soluble Vitamin (FSV) Deficiency: Obtain baseline levels and monitor during treatment. Supplement with FSV if deficiency is observed. If FSV deficiency persists or worsens despite FSV supplementation, consider permanent discontinuation of treatment.

( 5.3 ) Bleeding: Interrupt treatment with LYNAVOY if bleeding occurs. Optimize treatment of FSV deficiency and consider restarting LYNAVOY once the patient is clinically stable. Fracture: IBAT inhibitors have been associated with bone fractures.

Monitor bone health and ensure adequate FSV levels.

5.1Liver Test Elevations In Study 1, liver test elevations were observed more commonly in LYNAVOY-treated patients compared to placebo-treated patients [see Adverse Reactions (6.1) ] . Obtain baseline liver tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin [TB], direct bilirubin [DB], alkaline phosphatase [ALP]) prior to initiating treatment with LYNAVOY and monitor the levels per standard clinical practice for PBC patients during treatment with LYNAVOY. If new liver test elevations occur, monitor ALT, AST, TB, DB, and ALP more frequently.

If liver test elevations persist, discontinue LYNAVOY.

5.2Diarrhea Diarrhea was reported as the most common adverse reaction in patients treated with LYNAVOY [see Adverse Reactions (6.1) ] . If diarrhea occurs, advise patients to monitor for dehydration. Consider interrupting or discontinuing LYNAVOY treatment if diarrhea persists.

5.3Fat-Soluble Vitamin Deficiency LYNAVOY may adversely affect absorption of fat-soluble vitamins (FSV). FSV include vitamins A, D, E, and K [see Adverse Reactions (6.1) ]. Obtain serum FSV levels (vitamins A, D, and E) and INR prior to initiation of LYNAVOY and monitor the levels periodically during treatment, along with any clinical manifestations of FSV deficiency.

Supplement with FSV if FSV deficiency is diagnosed. Consider discontinuing LYNAVOY if FSV deficiency persists or worsens despite adequate FSV supplementation. Bleeding Bleeding was observed more frequently in LYNAVOY-treated patients compared to placebo-treated patients [see Adverse Reactions (6.1) ] .

If bleeding occurs, interrupt LYNAVOY treatment and evaluate for potential FSV deficiency. LYNAVOY can be restarted if FSV deficiency is corrected, levels are maintained, and bleeding has resolved. Bone Fracture IBAT inhibitors have been associated with bone fractures.

Monitor bone health and ensure adequate FSV levels.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Liver Test Elevations [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Fat-Soluble Vitamin Deficiency [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥5%) are: diarrhea, abdominal pain, nausea, increased ALT, hemorrhage, increased AST, headache, dyspepsia, gastroesophageal reflux disease, abdominal distension, dizziness, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals 1-844-782-4278 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LYNAVOY is based on Study 1, a randomized, double-blind, placebo-controlled, 24-week study of LYNAVOY 40 mg administered orally twice daily [see Clinical Studies (14) ] . Drug discontinuation due to adverse reactions was seen more frequently in LYNAVOY-treated patients (14%) than in placebo-treated patients (5%).

Diarrhea, abdominal pain, ALT increase, and AST increase were the most common causes of treatment discontinuation. Common Adverse Reactions Table 1 displays the most common adverse reactions that occurred in at least 5% of LYNAVOY-treated patients in Study 1. Table 1.

Adverse Reactions Occurring in ≥5% of Adult Patients with PBC Treated with LYNAVOY in Study 1 (24 weeks), Safety Dataset Adverse reactions were only included in table above if they occurred more frequently in patients treated with LYNAVOY compared to placebo-treated patients. Adverse Reaction LYNAVOY (n = 119) n (%) Placebo (n = 118) n (%) Diarrhea Diarrhea includes diarrhea and frequent bowel movements. 74 (62) 21 (18) Abdominal pain Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort.

31 (26) 12 (10) Nausea 12 (10) 11 (9) Increased alanine aminotransferase (ALT) 11 (9) 4 (3) Hemorrhage Hemorrhage includes contusion, ecchymosis, epistaxis, gastric hemorrhage, hematochezia, hemorrhagic disorder, intermenstrual bleeding, melena, petechiae, skin hemorrhage, vaginal hemorrhage, hematocrit decreased, and diarrhea hemorrhagic. 11 (9) 3 (3) Increased aspartate aminotransferase (AST) 10 (8) 1 (<1) Headache 10 (8) 4 (3) Dyspepsia 9 (8) 1 (<1) Gastroesophageal reflux disease 8 (7) 5 (4) Abdominal distension 8 (7) 6 (5) Dizziness 7 (6) 4 (3) Arthralgia 7 (6) 6 (5) Less Common Adverse Reactions Additional adverse reactions that occurred more frequently in the LYNAVOY group compared to placebo group, in less than <5% of patients, included hyperbilirubinemia, hypertriglyceridemia, urinary tract infections, and dry mouth.

Specific Adverse Reactions Liver Test Elevations In Study 1, liver test elevations (ALT, AST, TB, or ALP) were observed more commonly in LYNAVOY-treated patients 17 (14%) compared to placebo-treated patients 7 (6%). Six (5%) of LYNAVOY-treated patients discontinued treatment due to liver test elevations during the study, compared to 2 (2%) of placebo-treated patients. Elevations in ALT to more than 3 times baseline levels occurred in 8 (7%) of LYNAVOY-treated patients compared to 4 (3%) of placebo-treated patients.

Elevations in TB to more than 2 times baseline levels occurred in 9 (8%) of LYNAVOY-treated patients compared to 3 (3%) of placebo-treated patients. Diarrhea In Study 1, diarrhea was observed in 74 (62%) of patients in the LYNAVOY-treated group compared to 21 (18%) in the placebo-treated group. Most diarrhea events occurred within the first 20 days of initiating treatment.

Of those who experienced diarrhea, 56/74 (76%) of LYNAVOY-treated patients and 10/21 (48%) of placebo-treated patients, did so within the first 20 days. Of the patient… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 102 words ▾

7 DRUG INTERACTIONS Bile Acid Binding Resins : Administer at least 4 hours before or 4 hours after administration of LYNAVOY. ( 7.1 )

7.1Effects of Bile Acid Binding Resins on LYNAVOY Instruct patients to take LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin [see Dosage and Administration (2.2) ] . Based on in vitro data, bile acid resins may bind linerixibat in the gut [see Clinical Pharmacology (12.3) ]. Concomitant use of bile acid binding resins with LYNAVOY can potentially inhibit the effects of LYNAVOY on the ileal bile acid transporter (IBAT).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no data on the use of LYNAVOY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Use of LYNAVOY during pregnancy is expected to result in minimal fetal exposure because systemic absorption following oral administration is low [see Clinical Pharmacology (12.3) ] . Linerixibat may inhibit the absorption of fat-soluble vitamins [see Warnings and Precautions (5.3) , Clinical Considerations ] .

In animal reproduction studies, in which linerixibat was administered orally to pregnant rabbits and rats during the period of organogenesis, no malformations or effects on embryo-fetal survival were reported at exposures 470 and 1,100 times the recommended human dose, respectively (see Data ) . The background risk of 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.

There is a pregnancy safety study that monitors pregnancy exposures and outcomes in women who have taken LYNAVOY during pregnancy. Pregnant women exposed to LYNAVOY, or their healthcare providers, should report LYNAVOY exposure by contacting Intercept Pharmaceuticals at 1-844-782-4278. Clinical Considerations Fetal/Neonatal Adverse Reactions Linerixibat may inhibit the absorption of fat-soluble vitamins (FSV).

FSV are essential for normal fetal growth and development. Monitor pregnant patients for FSV deficiency and supplement as needed. Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) ] .

Data Animal Data No effects on embryo-fetal development were observed in pregnant rats treated orally with linerixibat up to 1,000 mg/kg/day (approximately 1,100 times the recommended dose based on AUC [area under the plasma concentration-time curve]) or in pregnant rabbits treated orally with linerixibat up to 125 mg/kg/day (approximately 470 times the recommended dose based on AUC) during the period of organogenesis. No effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with linerixibat up to 1,000 mg/kg/day during organogenesis through lactation.

Maternal systemic exposure to linerixibat at the maximum dose tested was approximately 1,100 times the recommended human dose based on AUC.

8.2Lactation Risk Summary Linerixibat has low absorption following oral administration, and exposure of the infant to linerixibat through breast milk is not expected at the recommended dosage [see Clinical Pharmacology (12.3) ]. There are no data on the presence of linerixibat in human milk, effects on the breastfed infant, or effects on milk production. LYNAVOY may reduce absorption of fat-soluble vitamins [see Warning and Precautions (5.3) ] .

Monitor maternal FSV levels and increase FSV intake if FSV deficiency is observed during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LYNAVOY and any potential adverse effects on the breastfed child from LYNAVOY or from the underlying maternal condition.

8.4Pediatric Use The safety and efficacy of LYNAVOY have not been established in pediatric patients.

8.5Geriatric Use Of the 119 patients that received LYNAVOY in Study 1, 25 (21%) were aged 65 years and older and 3 (3%) were aged 75 years and older [see Clinical Studies (14) ] . No overall differences in safety or effectiveness were observed between patients 65 to less than 75 years of age and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) ] . Clinical studies of LYNAVOY did not include sufficient numbers of patients aged 75 and older to determine whether they respond differently f… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no data on the use of LYNAVOY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Use of LYNAVOY during pregnancy is expected to result in minimal fetal exposure because systemic absorption following oral administration is low [see Clinical Pharmacology (12.3) ] . Linerixibat may inhibit the absorption of fat-soluble vitamins [see Warnings and Precautions (5.3) , Clinical Considerations ] .

In animal reproduction studies, in which linerixibat was administered orally to pregnant rabbits and rats during the period of organogenesis, no malformations or effects on embryo-fetal survival were reported at exposures 470 and 1,100 times the recommended human dose, respectively (see Data ) . The background risk of 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.

There is a pregnancy safety study that monitors pregnancy exposures and outcomes in women who have taken LYNAVOY during pregnancy. Pregnant women exposed to LYNAVOY, or their healthcare providers, should report LYNAVOY exposure by contacting Intercept Pharmaceuticals at 1-844-782-4278. Clinical Considerations Fetal/Neonatal Adverse Reactions Linerixibat may inhibit the absorption of fat-soluble vitamins (FSV).

FSV are essential for normal fetal growth and development. Monitor pregnant patients for FSV deficiency and supplement as needed. Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) ] .

Data Animal Data No effects on embryo-fetal development were observed in pregnant rats treated orally with linerixibat up to 1,000 mg/kg/day (approximately 1,100 times the recommended dose based on AUC [area under the plasma concentration-time curve]) or in pregnant rabbits treated orally with linerixibat up to 125 mg/kg/day (approximately 470 times the recommended dose based on AUC) during the period of organogenesis. No effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with linerixibat up to 1,000 mg/kg/day during organogenesis through lactation.

Maternal systemic exposure to linerixibat at the maximum dose tested was approximately 1,100 times the recommended human dose based on AUC.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and efficacy of LYNAVOY have not been established in pediatric patients.

🧓 Geriatric Use 101 words ▾

8.5Geriatric Use Of the 119 patients that received LYNAVOY in Study 1, 25 (21%) were aged 65 years and older and 3 (3%) were aged 75 years and older [see Clinical Studies (14) ] . No overall differences in safety or effectiveness were observed between patients 65 to less than 75 years of age and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) ] . Clinical studies of LYNAVOY did not include sufficient numbers of patients aged 75 and older to determine whether they respond differently from younger adult patients.

🆘 Overdosage 67 words ▾

10 OVERDOSAGE Dose-dependent increases in the incidence of gastrointestinal adverse reactions have been observed with LYNAVOY dosages 4.5-fold higher than the recommended dosage. There is no specific antidote for LYNAVOY. If an overdose occurs, discontinue LYNAVOY, monitor the patient for any signs and symptoms and institute general supportive measures as needed.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Linerixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids in the terminal ileum leading to their increased fecal elimination. Cholestatic pruritus is a common symptom in patients with PBC, and the pathophysiology of pruritus in patients with PBC is not completely understood.

Although the complete mechanism by which linerixibat improves pruritus in PBC patients is unknown, it may involve inhibition of the IBAT as observed by a decrease in mediators of pruritus including serum bile acids [see Clinical Pharmacology (12.2) ] .

12.2Pharmacodynamics Linerixibat reduces total serum bile acids in healthy volunteers and PBC patients with cholestatic pruritus. In healthy volunteers, serum bile acids were reduced within 1 day of LYNAVOY treatment compared to placebo treatment. In Study 1, total serum bile acids were reduced from baseline over the 24-week treatment period in the LYNAVOY group when compared to the placebo group.

12.3Pharmacokinetics Due to the low systemic absorption of linerixibat, pharmacokinetic parameters cannot be reliably calculated at the recommended doses. Following a single dose administration of 40 mg of linerixibat, concentrations of linerixibat in healthy volunteers were below the limit of quantification (10 pg/mL) in the majority of plasma samples. Following multiple doses of linerixibat ranging from 3 mg (0.08 times the approved recommended dose) twice daily to 90 mg (2.25 times the approved recommended dose) twice daily in healthy volunteers, the majority of plasma samples were below the limit of quantification (1,000 pg/mL).

Absorption Linerixibat is minimally absorbed following oral administration and the absolute oral bioavailability of linerixibat is 0.05%. Following a single oral administration of linerixibat 40 mg in healthy adults under fasted conditions, median T max was 4.5 hours and mean linerixibat (%CV) C max and AUC 0-t were 31.1 pg/mL (173) and 105 h∙pg/mL (419), respectively. Following multiple doses of LYNAVOY 40 mg twice daily in PBC patients with cholestatic pruritus, the mean linerixibat C max (95% CI) was 922 pg/mL (347, 1,500).

Effect of Food Concomitant administration of a high-fat meal with a single dose of linerixibat 40 mg oral tablets delayed median T max from 4.5 hours to 8.0 hours and resulted in decreases of 21.9% and 33.7% in AUC 0-t and C max , respectively, compared to administration under fasted conditions in healthy adults. Pharmacokinetic parameters in the food effect study were highly variable. The effect of food on the changes of systemic exposures to linerixibat is not clinically significant.

Despite the lack of clinically important pharmacokinetic effects with food, LYNAVOY should be administered at least 30 minutes prior to food or beverage (other than water) to allow linerixibat to enter the gastrointestinal lumen prior to release of bile acids upon eating [see Dosage and Administration (2.1) ] . Distribution The in vitro plasma protein binding range of linerixibat was 71.0-76.4%. Elimination Following a single oral dose of linerixibat 90 mg (2.25 times the approved recommended dose) in healthy adults, the mean half-life (t 1/2 ) was 6.76 hours.

Metabolism: Following administration of oral radiolabeled linerixibat, no linerixibat metabolites were detected in plasma. Three minor oxidative metabolites were detected in feces, and each accounted for negligible radioactivity (<1%), demonstrating that linerixibat is minimally metabolized in humans. Excretion: Following administration of oral radiolabeled linerixibat, approximately 97% of the dose was excreted in feces; approximately 0.04% of the dose was excreted in urine.

More than 99% of fecal radioactivity was determined to be unchanged and unabsorbed linerixibat. Following intravenous administration of radiolabeled linerixibat, systemic linerixibat elimination was approximately 20% renal and 80% fecal.… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 96 words ▾

12.1Mechanism of Action Linerixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids in the terminal ileum leading to their increased fecal elimination. Cholestatic pruritus is a common symptom in patients with PBC, and the pathophysiology of pruritus in patients with PBC is not completely understood.

Although the complete mechanism by which linerixibat improves pruritus in PBC patients is unknown, it may involve inhibition of the IBAT as observed by a decrease in mediators of pruritus including serum bile acids [see Clinical Pharmacology (12.2) ] .

📦 How Supplied / Storage and Handling 105 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LYNAVOY (linerixibat) tablets, 40 mg, are purple, biconvex, round, film-coated tablets debossed with "GS 3JG" on one side and are supplied in bottles of 60 tablets (NDC 69516-140-60). LYNAVOY is packaged in white high density polyethylene (HDPE) bottles with polypropylene child-resistant closures and a polyethylene faced induction heat seal liner containing a HDPE canister with silica gel desiccant. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store in the original package to protect from moisture. Keep the bottle tightly closed.

📦 Storage and Handling 40 words ▾

Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture. Keep the bottle tightly closed.

📋 Description 117 words ▾

11 DESCRIPTION Linerixibat is an orally administered IBAT inhibitor. Linerixibat has the chemical name 3-((((3 R ,5 R )-3-butyl-3-ethyl-7-methyloxy-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydrobenzo[ f ][1,4]thiazepin-8-yl)methyl)amino)pentanedioic acid. The molecular formula of linerixibat is C 28 H 38 N 2 O 7 S with a molecular weight of 546.68 g/mol.

Linerixibat has the following chemical structure: "*" represent chiral centers. Linerixibat is a white to off-white solid. Its solubility in aqueous solutions is pH-dependent and varies from very slightly to slightly soluble.

LYNAVOY is available for oral administration as tablets containing 40 mg linerixibat and the following excipients: croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The tablet film-coating contains black iron oxide, hypromellose, polyethylene glycol, red iron oxide, and titanium dioxide. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Instruct patients to take LYNAVOY at least 30 minutes before any food or beverage (other than water) [see Dosage and Administration (2.1) ] . Instruct patients that if they miss a dose of LYNAVOY to take it as soon as possible and at least 30 minutes before their next meal, then resume the original dosing schedule.

If a dose is missed by more than 6 hours, skip the dose and resume the original dosing schedule. Advise patients to not take a double dose to make up for a missed dose [see Dosage and Administration (2.1) ]. Instruct patients to take LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin [see Drug Interactions (7.1) ].

Liver Test Abnormalities Advise patients that their healthcare provider will obtain liver tests before starting LYNAVOY and periodically during treatment with LYNAVOY [see Warnings and Precautions (5.1) ]. Diarrhea Advise patients to monitor for dehydration. Consider interrupting or discontinuing LYNAVOY treatment if diarrhea persists. [see Warnings and Precautions (5.2) ] .

Fat-Soluble Vitamin (FSV) Deficiency Advise patients that INR (for vitamin K) and serum levels of vitamins A, D, E will be obtained before starting treatment and periodically during treatment to assess for FSV deficiency [see Warnings and Precautions (5.3) ] . Inform patients that they may bleed more easily or may bleed longer, and could develop bone fractures. Advise patients to call their healthcare provider for any signs or symptoms of bleeding, or if they have a bone fracture.

Pregnancy Inform patients that there is a pregnancy safety study tracking pregnancy exposures and outcomes with LYNAVOY. Ask pregnant women to report LYNAVOY exposure by contacting Intercept Pharmaceuticals at 1-844-782-4278. LYNAVOY is a trademark of GSK Group of Companies licensed to Intercept Pharmaceuticals, Inc.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Due to the low systemic absorption of linerixibat, pharmacokinetic parameters cannot be reliably calculated at the recommended doses. Following a single dose administration of 40 mg of linerixibat, concentrations of linerixibat in healthy volunteers were below the limit of quantification (10 pg/mL) in the majority of plasma samples. Following multiple doses of linerixibat ranging from 3 mg (0.08 times the approved recommended dose) twice daily to 90 mg (2.25 times the approved recommended dose) twice daily in healthy volunteers, the majority of plasma samples were below the limit of quantification (1,000 pg/mL).

Absorption Linerixibat is minimally absorbed following oral administration and the absolute oral bioavailability of linerixibat is 0.05%. Following a single oral administration of linerixibat 40 mg in healthy adults under fasted conditions, median T max was 4.5 hours and mean linerixibat (%CV) C max and AUC 0-t were 31.1 pg/mL (173) and 105 h∙pg/mL (419), respectively. Following multiple doses of LYNAVOY 40 mg twice daily in PBC patients with cholestatic pruritus, the mean linerixibat C max (95% CI) was 922 pg/mL (347, 1,500).

Effect of Food Concomitant administration of a high-fat meal with a single dose of linerixibat 40 mg oral tablets delayed median T max from 4.5 hours to 8.0 hours and resulted in decreases of 21.9% and 33.7% in AUC 0-t and C max , respectively, compared to administration under fasted conditions in healthy adults. Pharmacokinetic parameters in the food effect study were highly variable. The effect of food on the changes of systemic exposures to linerixibat is not clinically significant.

Despite the lack of clinically important pharmacokinetic effects with food, LYNAVOY should be administered at least 30 minutes prior to food or beverage (other than water) to allow linerixibat to enter the gastrointestinal lumen prior to release of bile acids upon eating [see Dosage and Administration (2.1) ] . Distribution The in vitro plasma protein binding range of linerixibat was 71.0-76.4%. Elimination Following a single oral dose of linerixibat 90 mg (2.25 times the approved recommended dose) in healthy adults, the mean half-life (t 1/2 ) was 6.76 hours.

Metabolism: Following administration of oral radiolabeled linerixibat, no linerixibat metabolites were detected in plasma. Three minor oxidative metabolites were detected in feces, and each accounted for negligible radioactivity (<1%), demonstrating that linerixibat is minimally metabolized in humans. Excretion: Following administration of oral radiolabeled linerixibat, approximately 97% of the dose was excreted in feces; approximately 0.04% of the dose was excreted in urine.

More than 99% of fecal radioactivity was determined to be unchanged and unabsorbed linerixibat. Following intravenous administration of radiolabeled linerixibat, systemic linerixibat elimination was approximately 20% renal and 80% fecal. Specific Populations No clinically significant differences in changes of total serum bile acid concentrations were observed with linerixibat based on body weight, age, sex, or race (White, Black, or Asian).

Patients with Hepatic Impairment: Of 238 patients enrolled in Study 1, 25 (11%) patients were diagnosed with cirrhosis (F4, Child-Pugh A), out of which 13 (5%) patients received linerixibat treatment. A general trend of higher exposure of linerixibat was observed in patients with cirrhosis compared to patients without cirrhosis, although the number of patients was very small. In a pharmacokinetic study in patients with moderate hepatic impairment (Child-Pugh B), the mean AUC (0-∞) and C max values were approximately 13-fold and 9.4-fold higher than matched healthy patients.

The clinical significance of this increase is unknown. Pharmacokinetics of linerixibat have not been evaluated in patients with severe hepatic impairment (Child-Pugh C). Drug Interaction Studies Effect of Bile Acid Binding Resins on Linerixibat : Approximately… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 61 words ▾

12.2Pharmacodynamics Linerixibat reduces total serum bile acids in healthy volunteers and PBC patients with cholestatic pruritus. In healthy volunteers, serum bile acids were reduced within 1 day of LYNAVOY treatment compared to placebo treatment. In Study 1, total serum bile acids were reduced from baseline over the 24-week treatment period in the LYNAVOY group when compared to the placebo group.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of LYNAVOY was evaluated in Study 1 (GLISTEN, NCT04950127), a 24-week, randomized, double-blind, placebo-controlled trial. The study included 238 adult patients, aged 30 to 80 years, with a confirmed diagnosis of PBC and presence of pruritus at baseline. Patients were randomized to LYNAVOY 40 mg orally twice daily (N = 119) or placebo (N = 119) for 24 weeks.

At baseline, 97% of patients were receiving UDCA, and 47% of patients were receiving concomitant antipruritic drugs. Thirteen (11%) of LYNAVOY-treated and 12 (10%) of placebo-treated patients had compensated liver cirrhosis (F4, Child-Pugh A). Baseline Demographics and Characteristics The mean age of patients in Study 1 was 55.8 years (range 30 to 80); 95% were female, 62% were White, 30% were Asian, 3% were American Indian or Alaska Native, and <1% were Black.

Twenty-three percent of patients were Hispanic or Latino. Patients were excluded from the study if they had hepatic decompensation, chronic viral hepatitis, symptomatic cholelithiasis, active cholecystitis, primary sclerosing cholangitis, alcoholic liver disease, bariatric surgery with ileal bypass, clinically significant diarrhea, or severe renal impairment (eGFR <30 mL/min/1.73 m 2 ). Baseline liver tests are presented in Table 2.

Table 2: Baseline Liver Tests in Adults with PBC in Study 1 Characteristics Overall (N=238) ALP (IU/L IU/L = International Unit per Liter ) Mean (range) 234 (46.5 to 1,102) ≤ 1 times ULN 24% > 1 times ULN and <1.67 times ULN 29% ≥1.67 times ULN 48% TB (mg/dL) Mean (range) 0.69 (0.15 to 2.76) ≤ 1 times ULN 87% > 1 times ULN 13% Efficacy Assessments Itch Severity Patients rated their worst itch severity twice daily (in the morning and evening) using the 11-point Worst Itch Numeric Rating Scale (NRS), with possible scores ranging from 0 (no itching) to 10 (worst imaginable itching).

The Worst Daily Itch Score was computed as the worst (highest) of the two scores recorded in a day. The Weekly Itch Score was computed as the average of the Worst Daily Itch Scores across the 7 days in a week. The Monthly Itch Score was computed as the worst (highest) Weekly Itch Score within a 4-week period.

Patients were included in Study 1 if their Monthly Itch Score in the 4 weeks preceding randomization was 4 or greater. The mean (SD) Monthly Itch Score at baseline was 7.3 (1.5). Sleep Interference Sleep interference due to pruritus was assessed each morning using the 11-point Sleep Interference NRS, with possible scores ranging from 0 (did not interfere) to 10 (completely interfered).

The Weekly Sleep Score was computed as the average of the daily sleep scores recorded over the 7 days in a week. The Monthly Sleep Score was computed as the worst (highest) Weekly Sleep Score within a 4-week period. The mean (SD) Monthly Sleep Score at baseline was 6.3 (2.4).

Efficacy Results Worst Itch Severity Table 3 presents the efficacy results for LYNAVOY and placebo treatment groups, based on the primary endpoint of change from baseline in Monthly Itch Score over 24 weeks. Patients who received LYNAVOY demonstrated a greater improvement from baseline in pruritus compared with placebo over 24 weeks of treatment. Table 3.

Efficacy Results for Monthly Itch Score The Monthly Itch Score was computed as the worst (highest) Weekly Itch Score within a 4-week period. in Adults with PBC Over 24 Weeks in Study 1 LYNAVOY (n = 119) Placebo (n = 118) SD=Standard Deviation, LS = Least Squares; SE=Standard Error; CI=Confidence Interval. Baseline Monthly Itch Score 7.33

7.36Mean (SD) (1.63) (1.45) Change from Baseline in Monthly Itch Score Over 24 Weeks Based on least squares means from a mixed-effect model for repeated measures with terms for treatment, visit, treatment by visit interaction, baseline itch, baseline itch by visit interaction, and use of baseline concomitant itch medication. Change from Baseline LS Mean (SE) -2.86 -2.15 (0.19) (0.18) LS Mean Difference vs. Placebo -0.72 (-1.15, -0.28) (… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 110 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Linerixibat was not tumorigenic in a 2-year oral carcinogenicity study in rats with oral administration of up to 1,000 mg/kg/day (approximately 3,900 times the recommended dose based on AUC). In a 26-week oral carcinogenicity study in TgRasH2 mice, no drug-related tumors were observed following administration of linerixibat up to 160 mg/kg/day. Mutagenesis Linerixibat was negative in in vitro (bacterial reverse mutation, chromosomal aberration in mammalian cells) and in vivo (rat bone marrow micronucleus) assays.

Impairment of Fertility No effects on fertility or early embryonic development were observed in male and female rats treated orally with linerixibat up to 1,000 mg/kg/day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 107 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Linerixibat was not tumorigenic in a 2-year oral carcinogenicity study in rats with oral administration of up to 1,000 mg/kg/day (approximately 3,900 times the recommended dose based on AUC). In a 26-week oral carcinogenicity study in TgRasH2 mice, no drug-related tumors were observed following administration of linerixibat up to 160 mg/kg/day. Mutagenesis Linerixibat was negative in in vitro (bacterial reverse mutation, chromosomal aberration in mammalian cells) and in vivo (rat bone marrow micronucleus) assays.

Impairment of Fertility No effects on fertility or early embryonic development were observed in male and female rats treated orally with linerixibat up to 1,000 mg/kg/day.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION LYNAVOY [LIN-ah-voy] (linerixibat) tablets, for oral use This Patient Information has been approved by the U.S. Food and Drug Administration Issued: March 2026 What is LYNAVOY? LYNAVOY is a prescription medicine used to treat itching ( pruritus ) in adults with primary biliary cholangitis (PBC).

LYNAVOY is not for use in people with severe liver disease (decompensated cirrhosis), or people who have or have had certain liver-related problems including bleeding of enlarged blood vessels in the stomach-area (variceal hemorrhage), fluid in the stomach-area (ascites), or nervous system problems (such as confusion, slurred speech, sluggish movements) caused by severe liver disease (hepatic encephalopathy). It is not known if LYNAVOY is safe and effective in children. Before using LYNAVOY, 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 LYNAVOY will harm your unborn baby. Pregnancy Safety Study : Pregnancy outcomes in women who become pregnant while using LYNAVOY is being collected. The purpose of this is to collect information about your health and your baby's health.

You or your healthcare provider should report your pregnancy by calling1-844-782-4278. are breastfeeding or plan to breastfeed. It is not known if LYNAVOY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using LYNAVOY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNAVOY and certain other medicines may interact with each other. Especially tell your healthcare provider if you take: bile acid binding resins (used to reduce absorption of bile acids from the intestine), such as cholestyramine or colesevelam.

These may reduce the effects of LYNAVOY. If you take any of these medicines, take LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use LYNAVOY? Always take LYNAVOY exactly as your healthcare provider has told you to.

Check with your healthcare provider if you are not sure. Take 1 LYNAVOY tablet by mouth 2 times each day (1 tablet in the morning and 1 tablet in the evening). Swallow the tablet whole with some water.

Take LYNAVOY at least 30 minutes before you have any food or drink (except water). If you take a bile acid binding resin such as cholestyramine or colesevelam, take it at least 4 hours before or 4 hours after taking LYNAVOY. If you miss a dose of LYNAVOY, take it as soon as possible and at least 30 minutes before your next meal.

If more than 6 hours have passed, skip the missed dose and take the next dose at the regular time. Don't take a double dose to make up for a missed dose. If you take too much LYNAVOY, call your healthcare provider, Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

What are the possible side effects of LYNAVOY? LYNAVOY may cause serious side effects, including: Increased liver enzymes. An increase in liver enzymes (liver-related blood tests) can happen in people who use LYNAVOY and can be serious.

Your healthcare provider will do blood tests to check your liver before starting treatment and as needed during treatment with LYNAVOY. Your healthcare provider may need to stop your treatment with LYNAVOY because of an increase in liver enzymes. Diarrhea.

Diarrhea can happen in people who use LYNAVOY and can be serious. Diarrhea can cause a loss of body fluid (dehydration). Check for signs of dehydration including thirst, dry mouth, urinating less often, or headache.

Call your healthcare provider if you have diarrhea that does not go away. Fat-Soluble Vitamin (FSV) Deficiency. A condition called FSV deficiency caused by low levels of certain vitamins… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label NDC 69516-140-60 Rx only Lynavoy (linerixibat) Tablets for oral use 40 mg 60 tablets PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label

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

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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.
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