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LYNKUET elinzanetant 60 mg Capsule, 12-count — NDC 50419-0475-73 package photo

LYNKUET elinzanetant 60 mg Capsule, 12-count

by Bayer HealthCare Pharmaceuticals Inc. · 1 BLISTER PACK in 1 CARTON (50419-475-73) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)
NDC 50419-0475-73
🏷️ FDA NDC (as labeled) 50419-475-73 billing pads the product segment with a zero
This package
Contains12-count Pack sizes3 compare ↓
Also priced by: Part D plans $10.07/unit — full pricing hub ↓
Also comes in: 24 capsules 50419-0475-72 60 capsules 50419-0475-05
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 50419-475-73
Product NDC 50419-475
11-digit billing NDC 50419047573
RxCUI 2725516, 2725522
UNII NZW2BOW35N
Application # NDA219469
SPL Set ID f42884ff-7dff-419c-8a0c-affe2ed73818
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-24
Route ORAL
Dosage form CAPSULE
Substance ELINZANETANT
GCN Seq No 088169
GCN 58263
HICL code 050837
Ingredient (HICL) Elinzanetant
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G6
Therapeutic class — intermediate (HIC2) Menopausal Symptoms Suppressants, Non-Hormonal
HIC3 code G6B
Therapeutic class — specific (HIC3) Menopausal Symptoms Suppressant-Nk Receptor Antag
AHFS code 28:92.00.00
AHFS class Central Nervous System Agents, Misc.
FDB label name LYNKUET 60 MG CAPSULE
FDB brand name Lynkuet
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50419-475-73 — 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 → 50419-0475-73. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other gynecologicals class.

Drug family (ATC) Other gynecologicals
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.

🏭 Manufacturer & labeler

LabelerBayer HealthCare Pharmaceuticals Inc.
Application holderBAYER HEALTHCARE PHARMACEUTICALS INC
FDA applicationNDA219469 (NDA)
Labeler code50419
First marketedOct 2025
Product typeHuman Prescription Drug
Portfolio62 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

Label name LYNKUET 60 MG CAPSULE Ingredient Elinzanetant
📖 What it is MedlinePlus · NLM

Elinzanetant is used to treat hot flashes (sudden strong feelings of heat in the face, neck, and chest and sweating) due to menopause. Elinzanetant is in a class of medications called neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonists. It works by changing the nerve response in the area of the brain that causes hot flashes.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lynkuet works differently from hormone therapy. Instead of replacing estrogen, it blocks specific receptors in your brain — called NK1 and NK3 — that are involved in triggering hot...
  • What exactly does Lynkuet do for hot flashes?
  • No — Lynkuet must not be used during pregnancy. Animal studies show it can cause pregnancy loss or stillbirth. Before you start, your doctor will confirm you're not pregnant. If yo...
  • Can I take Lynkuet if I'm still having periods or could get pregnant?
📖 Read our full Elinzanetant 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.

💊 What it looks like

Color Red
ShapeCapsule
ImprintEZN60
Size24 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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII MJ9J2BSO5V
    A synthetic liquid made from glycerin and fatty acids, used as a solvent and emulsifier to help dissolve and mix drug ingredients together in liquid medicines.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII G7515SW10N
    A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
  • UNII C4YAD5F5G6
    A natural oil-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together in the medicine and may improve how the body absorbs certain drugs.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII D1JT611TNE
    A metallic element used as a white colorant and opacifying agent in tablets and capsules. It provides color consistency and helps make medicines visually uniform.

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

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

Inactive ingredient FAQ

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

💲 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 · Q2 2026 $10.07 $120.85 / 12 capsules
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
Lynkuet 60 mgthis 50419-0475-73 Bayer 12 capsules — — 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

🏛️
2025
First FDA approval
Oct 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2045
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 May 2045. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 24, 2025 RLD RS ⏳ ~18.7 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 12264164 — method of use (U-3622)
US 11787820 — method of use (U-3622)
US 10195205 — method of use (U-3622)
US 12533358 — method of use (U-4402)
US 7683056 — drug substance
US 10774091 — drug product
Exclusivity NCE
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043 2045
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 (6)
PatentTypeUse codeExpires
US 12264164 ↗ Method of use U-3622 Mar 13, 2039
US 11787820 ↗ Method of use U-3622 Mar 13, 2039
US 10195205 ↗ Method of use U-3622 May 18, 2036
US 12533358 ↗ Method of use U-4402 May 14, 2045
US 7683056 ↗ Drug substance — Sep 15, 2027
US 10774091 ↗ Drug product — Mar 13, 2039
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Oct 24, 2030
Common questions
Is there a generic version of LYNKUET 60 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LYNKUET 60 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2045 — 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lynkuet — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lynkuet. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$631.5K
Claims incl. refills
878
Beneficiaries
674
Spend / beneficiary
$936.94
Spend / claim
$719.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
50419-0475-05 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01) $9.98 / ea $598.83 2025-10-24 Active
50419-0475-72 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71) — — 2025-10-24 Active
50419-0475-73 You're viewing this 1 BLISTER PACK in 1 CARTON (50419-475-73) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71) — — 2026-05-07 Active

Pack size FAQ

What quantity is in NDC 50419-0475-73?
NDC 50419-0475-73 is a 12-count package — 1 blister pack in 1 carton / 12 capsule in 1 blister pack.
What is the difference between NDC 50419-0475-73 and NDC 50419-0475-72?
Both are LYNKUET elinzanetant 60 mg Capsule — the drug itself is identical. NDC 50419-0475-73 is the 12-count package, while NDC 50419-0475-72 is the 24 capsules package.
What NDC number is used to bill for this package of LYNKUET elinzanetant 60 mg Capsule?
Bill NDC 50419-0475-73 — the 11-digit billing format is 50419047573. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 ✓ Available
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 ✓ Available
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 50419-475-73, 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: 50419-0475-73, written without dashes as 50419047573. 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 50419-0475-73, the first segment (50419) is the labeler code FDA assigned to Bayer HealthCare Pharmaceuticals Inc.; the middle segment (0475) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (73) 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 Bayer HealthCare Pharmaceuticals Inc.. 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 2 other package presentations of this same product, including 24 capsules (50419-0475-72), 60 capsules (50419-0475-05). 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?
Bayer HealthCare Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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 ⏱️ 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
🎯 Indications and Usage 48 words ▾

1 INDICATIONS AND USAGE LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is 120 mg (two 60 mg capsules) orally once daily at bedtime with or without food. ( 2.2 ) Swallow capsules whole. Do not cut, crush, or chew capsules. ( 2.2 ) See full prescribing information for LYNKUET dosage modification due to drug interactions. ( 2.3 )

2.1Recommended Evaluation and Testing Before Initiation of LYNKUET Exclude pregnancy in females of reproductive potential [see Contraindications (4) ], Warnings and Precautions (5.3) , and Use in Specific Populations (8.3) ]. Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with LYNKUET. Do not start LYNKUET if ALT or AST is ≥ 2 times upper limit of normal (ULN) or if the total bilirubin is ≥ 2 times ULN [see Warnings and Precautions (5.2) and Use in Specific Populations (8.7) ] .

2.2Recommended Dosage The recommended dosage of LYNKUET is 120 mg (two 60 mg capsules) orally once daily at bedtime at about the same time each day. If a dose is missed at bedtime, take the next dose as scheduled on the following day. Do not take two doses on the same day to make up for a missed dose. Take LYNKUET with or without food. Take LYNKUET with water and swallow capsules whole. Do not cut, crush or chew capsules.

2.3Dosage Modifications for Drug Interactions Dosage modifications for concomitant use with specific drugs are provided in Table 1 [see Drug Interactions (7.1) ]. Table 1: Dosage Modifications for Drug Interactions Concomitant Drug LYNKUET Dosage Strong CYP3A4 inhibitors and grapefruit (juice) Avoid concomitant use Moderate CYP3A4 inhibitors 60 mg (one capsule) orally once daily at bedtime [see Storage and Handling (16.2) ]. After discontinuation of the moderate CYP3A4 inhibitor (after 3 to 5 half-lives of the inhibitor), LYNKUET should be used at the usual dosage of 120 mg once daily.

Strong and Moderate CYP3A4 inducers Avoid concomitant use

💊 Dosage Forms and Strengths 25 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 60 mg, opaque red, oblong, soft, gelatin capsules, with white printing of "EZN60". Capsules: 60 mg ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy [see Use in Specific Populations (8.1 , 8.3) ] . Pregnancy. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS CNS Depressant Effect and Daytime Impairment: Advise patients about the potential for somnolence and other nervous system effects. Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved ( 5.1 ) Hepatic Transaminase Elevations: Perform bloodwork prior to initiation of LYNKUET to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the upper limit of normal (ULN) or if the total bilirubin is equal to or exceeds two times the ULN.

Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation. Advise patients to discontinue LYNKUET immediately in case of signs or symptoms suggesting liver injury. ( 5.2 ) Risk of pregnancy loss: May cause pregnancy loss or stillbirth when administered during pregnancy.

Exclude pregnancy in females of reproductive potential prior to initiating LYNKUET. Discontinue if pregnancy is confirmed ( 5.3 ) Risk of seizure ( 5.4 )

5.1Central Nervous System (CNS) Depressant Effect and Daytime Impairment In the three OASIS trials, nervous system effects (including somnolence, fatigue, vertigo, dizziness and presyncope) occurred in 11.9% of patients on LYNKUET compared to 3.5% on placebo. [see also Adverse Reactions (6.1) ]. Advise patients about the potential for somnolence and other nervous system effects. Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved [see Clinical Studies (14.3) ].

5.2Hepatic Transaminase Elevations Elevations in serum transaminase (ALT and/or AST) concentrations equal to or greater than three times the ULN occurred in 0.6% of patients receiving LYNKUET and 0.4% of patients receiving placebo up to 12 weeks in three clinical trials. Perform baseline bloodwork (including ALT, AST, alkaline phosphatase, and total and direct bilirubin) prior to initiation of LYNKUET to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the ULN or if the total bilirubin is equal to or exceeds two times the ULN.

Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation of therapy. Advise patients to discontinue LYNKUET immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain). Discontinue LYNKUET if transaminase elevations exceed five times the ULN or if transaminase elevations exceed three times the ULN and total bilirubin exceeds two times the ULN.

Exclude alternative causes of hepatic laboratory test elevations.

5.3Risk of Pregnancy Loss LYNKUET is contraindicated for use in pregnancy [see Contraindications (4) ]. Findings from animal studies suggest that LYNKUET can cause pregnancy loss or stillbirth. Exclude pregnancy in females of reproductive potential prior to initiating LYNKUET.

Advise females of reproductive potential to use effective contraception during treatment with LYNKUET and for 2 weeks after stopping LYNKUET [see Use in Specific Populations (8.1 , 8.3) ] .

5.4Risk of Seizure Seizure was reported in patients taking LYNKUET [ see Adverse Reactions (6.1 , 6.2) ]. In addition, convulsions were observed in studies conducted in male and female rats [see Nonclinical Toxicology (13.2) ]. Advise patients about the potential risk of seizure. Use LYNKUET with caution in patients with a history of seizures or with conditions that potentially lower the seizure threshold.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System (CNS) Depressant Effect and Daytime Impairment [see Warnings and Precautions (5.1) ] Hepatic Transaminase Elevations [see Warnings and Precautions (5.2) ] Risk of Seizure [ see Warnings and Precautions (5.4) ] The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 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 clinical practice. The safety of LYNKUET was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2, OASIS 3 ) in 1420 women . In OASIS 1 and OASIS 2 combined, 793 women received LYNKUET or placebo for 12 weeks.

After the first 12 weeks, 341 women randomized to LYNKUET continued to receive LYNKUET for another 14 weeks, with a total treatment duration of up to 26 weeks. In OASIS 1 and OASIS 2 combined, 349 women received placebo for the first 12 weeks and 348 women switched to LYNKUET for the next 14 weeks. In OASIS 3, 627 women received LYNKUET or placebo for up to 52 weeks to evaluate long-term safety [see Clinical Studies (14) ] .

Common Adverse Reactions In OASIS 1 and 2 combined, through the first 12 weeks, commonly reported adverse reactions in the LYNKUET group (≥2% and greater than in placebo) were headache, fatigue, gastroesophageal reflux disease, dizziness, nausea, and somnolence. Similar adverse reactions were seen in OASIS 3. Table 2 shows adverse reactions reported in at least 2% of women and more commonly in women taking LYNKUET than placebo in OASIS 3.

Table 2: Common Adverse Reactions Reported in ≥ 2% in LYNKUET and Greater than Placebo, Weeks 1-52 (OASIS 3) Adverse Reaction LYNKUET N=313 n (%) Placebo N=314 n (%) Headache 30 (9.6) 22 (7.0) Fatigue Includes asthenia. 23 (7.3) 9 (2.9) Dizziness Includes balance disorder, presyncope, vertigo, vertigo CNS origin, vertigo positional, and vestibular neuronitis. 19 (6.1) 6 (1.9) Somnolence Includes lethargy.

16 (5.1) 4 (1.3) Abdominal pain Includes abdominal discomfort, abdominal pain lower/upper. 14 (4.5) 8 (2.5) Rash Includes dermatitis, urticaria. 13 (4.2) 5 (1.6) Diarrhea 12 (3.8) 3 (1.0) Muscle spasms Includes muscle tightness.

10 (3.2) 2 (0.6) Other clinically important adverse reactions: Seizure was reported in one patient (<0.1%) with a history of seizures in the clinical trials of LYNKUET. Adverse Reactions Leading to Discontinuation In OASIS 3, adverse reactions leading to treatment discontinuation (≥1% in LYNKUET and greater than placebo) were abdominal pain (1.6%), fatigue (1.6%), depression (1.6%) and headache (1.3%). Photosensitivity In the OASIS trials, mild to moderate events of photosensitivity occurred in 0.5% of patients receiving LYNKUET and 0.1% of patients receiving placebo.

Onset of photosensitivity reactions ranged from day 1 to day 290. While discontinuation occurred in one patient, photosensitivity events in other patients resolved under continued treatment with LYNKUET [see Nonclinical Toxicology (13.2) ].

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of LYNKUET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing cases of seizure have been reported in patients treated with LYNKUET.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use with LYNKUET. ( 7.1 ) Moderate CYP3A4 Inhibitors: Reduce LYNKUET dosage to 60 mg once daily. ( 2.3 , 7.1 )21 Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with LYNKUET. ( 7.1 )

7.1Effects of Other Drugs on LYNKUET Elinzanetant is primarily metabolized via CYP3A4 enzyme. Table 3 describes drug interactions where concomitant use of another drug affects LYNKUET. Table 3: Drug Interactions: Concomitant Use of Other Drugs Affect the Use of LYNKUET Strong and Moderate CYP3A4 Inhibitors See www.fda.gov/CYPandTransporterInteractingDrugs for examples of strong and moderate CYP3A4 inhibitors, and CYP3A4 inducers.

Prevention or Management Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use. Moderate CYP3A4 Inhibitors: Reduce the LYNKUET dosage [see Dosage and Administration (2.2) ]. Clinical Effect(s) Strong and moderate CYP3A4 inhibitors increase elinzanetant exposure, which may increase the risk of LYNKUET-associated adverse reactions [see Clinical Pharmacology (12.3) ].

Strong and Moderate CYP3A4 Inducers Prevention or Management Strong and moderate CYP3A4 inducers: Avoid concomitant use. Clinical Effect(s) Strong and moderate CYP3A4 inducers decrease elinzanetant exposure, which may reduce the effectiveness of LYNKUET.

7.2Effects of LYNKUET on Other Drugs CYP3A4 Substrates Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A4 substrates where minimal concentration changes may lead to serious adverse reactions. See www.fda.gov/CYPandTransporterInteractingDrugs for examples of CYP3A4 substrates. Elinzanetant is a weak inhibitor of CYP3A4.

Concomitant use of LYNKUET increases exposure of CYP3A4 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS End Stage Renal Disease with or without hemodialysis: Not recommended. ( 8.6 ) Moderate to Severe Hepatic Impairment: Not recommended. ( 8.7 )

8.1Pregnancy Risk Summary LYNKUET is contraindicated in pregnancy [see Contraindications (4) ]. If pregnancy occurs during the use of LYNKUET, discontinue treatment. Based on findings from animal reproduction studies, LYNKUET may cause pregnancy loss or stillbirth but not fetal malformations when administered during pregnancy.

There are no data on the use of LYNKUET in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in rats, an increase in total litter loss or stillbirth and a decrease of neonatal pup viability was observed within the range of human therapeutic exposure when dams were treated orally throughout gestation and lactation [i.e., gestation day 6 to lactation day 21]. There was an increase in percentage of pre- and post-implantation embryo loss and decrease in fetal body weights at 16-fold the human therapeutic exposure when rat dams were treated orally prior to mating and through the early embryonic period [i.e., 22 days before mating to post-coitum day 6].

In rabbits, there was marked body weight loss and decreased food consumption in dams treated orally during gestation day 7 to 19 at doses equivalent to human therapeutic exposure (see Data ). Data Animal Data In a fertility and early embryonic development study in female rats, once daily oral doses of elinzanetant were administered 22 days before mating through post-coitum day 6. Increased percentage of pre-implantation and post-implantation embryo loss, resulting in reduced litter size, and lower fetal body weights were seen at the dose of 100 mg/kg/day (14-fold the AUC (0-24) at the human therapeutic dose).

These effects were not observed following dosing at 25 mg/kg/day (3-fold the AUC (0-24) at the human therapeutic dose). In an embryo-fetal development study in pregnant rats, once daily oral doses of elinzanetant were administered throughout organogenesis from gestation day 6 to 17. No evidence of embryo-fetal lethality or teratogenicity occurred at doses ≤100 mg/kg/day (23-fold the AUC (0-24) at the human therapeutic dose) and no maternal toxicity occurred at doses ≤25 mg/kg/day (7-fold the AUC (0-24) at the human therapeutic dose).

In an embryo-fetal development study in pregnant rabbits, twice daily oral doses of elinzanetant were administered throughout organogenesis from gestation day 7 to 19. Maternal toxicity in the form of marked body weight loss and decreased food consumption leading to early sacrifice in 4 out of 27 females was observed at the highest tested dose of 140 mg/kg/day (equivalent to the AUC (0-24) at the human therapeutic dose). No evidence of embryo-fetal lethality or teratogenicity occurred in fetuses of surviving dams at doses ≤140 mg/kg/day (equivalent to the AUC (0-24) at the human therapeutic dose).

In a pre- and post-natal development study in rats, once daily oral doses of elinzanetant were administered from gestation day 6 to lactation day 21. A higher incidence of still born pups, an increase in total litter loss, a decrease in pup viability between postnatal days 0 and 4, and an increase in the number of neonatal pups without milk in the stomach were observed at a dose of ≥5 mg/kg/day (equivalent to the AUC (0-24) at the human therapeutic dose).

8.2Lactation Risk Summary There are no data on the presence of elinzanetant or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Elinzanetant is present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk (see Data ).

Data Animal Data Following administration of radiolabeled elinzanetant to lactating rats, approximately 6% of the elinzanetant dose was excreted in the milk. Principle human met…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary LYNKUET is contraindicated in pregnancy [see Contraindications (4) ]. If pregnancy occurs during the use of LYNKUET, discontinue treatment. Based on findings from animal reproduction studies, LYNKUET may cause pregnancy loss or stillbirth but not fetal malformations when administered during pregnancy.

There are no data on the use of LYNKUET in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in rats, an increase in total litter loss or stillbirth and a decrease of neonatal pup viability was observed within the range of human therapeutic exposure when dams were treated orally throughout gestation and lactation [i.e., gestation day 6 to lactation day 21]. There was an increase in percentage of pre- and post-implantation embryo loss and decrease in fetal body weights at 16-fold the human therapeutic exposure when rat dams were treated orally prior to mating and through the early embryonic period [i.e., 22 days before mating to post-coitum day 6].

In rabbits, there was marked body weight loss and decreased food consumption in dams treated orally during gestation day 7 to 19 at doses equivalent to human therapeutic exposure (see Data ). Data Animal Data In a fertility and early embryonic development study in female rats, once daily oral doses of elinzanetant were administered 22 days before mating through post-coitum day 6. Increased percentage of pre-implantation and post-implantation embryo loss, resulting in reduced litter size, and lower fetal body weights were seen at the dose of 100 mg/kg/day (14-fold the AUC (0-24) at the human therapeutic dose).

These effects were not observed following dosing at 25 mg/kg/day (3-fold the AUC (0-24) at the human therapeutic dose). In an embryo-fetal development study in pregnant rats, once daily oral doses of elinzanetant were administered throughout organogenesis from gestation day 6 to 17. No evidence of embryo-fetal lethality or teratogenicity occurred at doses ≤100 mg/kg/day (23-fold the AUC (0-24) at the human therapeutic dose) and no maternal toxicity occurred at doses ≤25 mg/kg/day (7-fold the AUC (0-24) at the human therapeutic dose).

In an embryo-fetal development study in pregnant rabbits, twice daily oral doses of elinzanetant were administered throughout organogenesis from gestation day 7 to 19. Maternal toxicity in the form of marked body weight loss and decreased food consumption leading to early sacrifice in 4 out of 27 females was observed at the highest tested dose of 140 mg/kg/day (equivalent to the AUC (0-24) at the human therapeutic dose). No evidence of embryo-fetal lethality or teratogenicity occurred in fetuses of surviving dams at doses ≤140 mg/kg/day (equivalent to the AUC (0-24) at the human therapeutic dose).

In a pre- and post-natal development study in rats, once daily oral doses of elinzanetant were administered from gestation day 6 to lactation day 21. A higher incidence of still born pups, an increase in total litter loss, a decrease in pup viability between postnatal days 0 and 4, and an increase in the number of neonatal pups without milk in the stomach were observed at a dose of ≥5 mg/kg/day (equivalent to the AUC (0-24) at the human therapeutic dose).

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use The efficacy and safety of LYNKUET in pediatric patients have not been established, and LYNKUET is not indicated in this population.

🧓 Geriatric Use 36 words ▾

8.5Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical trials utilizing LYNKUET to determine whether those over 65 years of age differ from younger women in their response to LYNKUET.

🆘 Overdosage 31 words ▾

10 OVERDOSAGE There is no specific antidote for LYNKUET. In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes. Elinzanetant has higher affinity for human NK1 receptors (pKi values of 8.7 to 10.2) and NK3 receptors (pKi values of 8.0 to 8.8) than for human NK2 receptors (pKi values of approximately 6.0).

12.2Pharmacodynamics Cardiac Electrophysiology No clinically relevant prolongation of the QTc interval was observed after single oral administration of elinzanetant at doses up to 5 times the maximum recommended dose. However, QTc prolongation effect of elinzanetant when co-administered with strong CYP3A4 inhibitors has not been sufficiently characterized.

12.3Pharmacokinetics Elinzanetant C max and AUC increased in a greater than dose-proportional manner (20% to 50%) over the dose range from 40 to 160 mg once daily (0.33 to 1.33 times the highest recommended dose). Elinzanetant steady state plasma concentrations were reached in 5 to 14 days after daily dosing. Elinzanetant accumulation is <2-fold at the approved recommended dosage.

Absorption Elinzanetant median (min-max) time to maximum plasma concentration (T max ) is 1.0 hours (1-2.5 hours) at steady state. Elinzanetant absolute bioavailability is 52% following oral administration. Effect of Food No clinically significant differences in elinzanetant pharmacokinetics were observed following administration with a high-calorie, high-fat meal containing approximately 1000 calories (500-600 calories from fat, 250 calories from carbohydrates, and 150 calories from protein).

Distribution The mean volume of distribution after intravenous administration at steady state of elinzanetant is 137 L. The plasma protein binding of elinzanetant is 99.7%. The blood-to-plasma ratio is between 0.6 and 0.7.

Elimination Elinzanetant elimination half-life was approximately 45 hours in women with vasomotor symptoms. The clearance of elinzanetant after a single intravenous dose was

8.77L/h. Metabolism Elinzanetant is primarily metabolized by CYP3A4 to yield three major active metabolites, M18/21, M27, and M30/34. These metabolites have similar potency for the human NK1 and NK3 receptors as compared to elinzanetant.

The ratio of these metabolites to parent in plasma is approximately 0.39. Excretion Following a single oral dose of radiolabeled elinzanetant in healthy subjects, approximately 90% of the dose was recovered in feces (50% unchanged) and less than 1% with urine. Specific Populations No clinically significant differences in the pharmacokinetics of LYNKUET were observed based on race.

Patients with Renal Impairment In patients with mild (eGFR 60 to <90 mL/min) renal impairment, mean elinzanetant C max increased 1.9-fold and AUC increased 1.6-fold. In patients with moderate (eGFR 30 to <60 mL/min) renal impairment, mean elinzanetant C max increased 1.8-fold and AUC increased 1.7-fold. In patients with severe (eGFR< 30 mL/min) renal impairment, mean elinzanetant C max increased 1.2-fold and AUC increased 1.1-fold.

Population pharmacokinetic analysis of the clinical trial data indicate similar exposure of elinzanetant in patients with mild and moderate renal impairment compared to patients with normal renal function. Elinzanetant has not been studied in patients with end-stage renal disease (eGFR <15 mL/min) [see Use in Specific Populations (8.7) ]. Patients with Hepatic Impairment In patients with Child-Pugh Class A (mild) hepatic impairment, mean elinzanetant C max increased 1.2-fold and AUC (0-24) increased 1.5-fold.

In patients with Child-Pugh Class B (moderate) hepatic impairment, mean elinzanetant C max and AUC (0-24) increased by 2.3-fold. Elinzanetant has not been studied in patients with Child-Pugh Class C (severe) hepatic impairment [see Use i…

🧬 Mechanism of Action 79 words ▾

12.1Mechanism of Action LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes. Elinzanetant has higher affinity for human NK1 receptors (pKi values of 8.7 to 10.2) and NK3 receptors (pKi values of 8.0 to 8.8) than for human NK2 receptors (pKi values of approximately 6.0).

📦 How Supplied / Storage and Handling 123 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied LYNKUET 60 mg capsules are supplied as opaque red, oblong, soft gelatin capsules, marked with white printing of "EZN60." LYNKUET capsules are available in the following package size: 60-count carton containing 5 blister cards (5 × 12 capsules) NDC 50419-475-05

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. For patients requiring a dosage modification (i.e., one 60 mg capsule once daily), instruct them to partially peel back the foil covering the blister cell exposing only one of the two capsules. Store the remaining capsule in the original blister card in the carton until the next dose.

📦 Storage and Handling 75 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. For patients requiring a dosage modification (i.e., one 60 mg capsule once daily), instruct them to partially peel back the foil covering the blister cell exposing only one of the two capsules. Store the remaining capsule in the original blister card in the carton until the next dose.

📋 Description 111 words ▾

11 DESCRIPTION LYNKUET is an NK1 and NK3 receptor antagonist. The chemical name of elinzanetant is 2-[3,5-bis(trifluoromethyl)phenyl]-N-{4-(4-fluoro-2-methylphenyl)-6-[(7S,9aS)-7-(hydroxymethyl)hexahydropyrazino[2,1-c][1,4]oxazin-8(1H)-yl]pyridin-3-yl}-N,2-dimethylpropanamide having a molecular formula of C 33 H 35 F 7 N 4 O 3 and a molecular weight of 668.7. The structural formula of elinzanetant is: Elinzanetant is a white to yellowish powder and is practically insoluble in water and slightly soluble under acidic conditions.

Each LYNKUET (elinzanetant) capsule for oral use contains 60 mg of elinzanetant and the following inactive ingredients: all-rac-α-Tocopherol, caprylocaproyl macrogolglycerides, glycerol monocaprylocaprate, glycerol mono-oleate, and polysorbate 80. The capsule is composed of edible ink, ferric oxide red, ferric oxide yellow, gelatin, sorbitol special-glycerin, and titanium dioxide. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). CNS Depressant Effect and Daytime Impairment Advise patients who experience somnolence and other nervous system effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved [see Warnings and precaution (5.1) and Clinical Studies (14.3) ]. Hepatic Transaminase Elevations Advise patients that bloodwork to evaluate for hepatic functions and injury will be obtained at baseline and three months after initiating therapy.

Advise patients to discontinue LYNKUET immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain). [see Warnings and Precautions (5.2) ]. Females of Reproductive Potential Exclude pregnancy in females of reproductive potential prior to initiating LYNKUET. Advise females of reproductive potential to use effective contraception during treatment with LYNKUET and for two weeks after discontinuing treatment and to discontinue LYNKUET if pregnancy is confirmed [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 , 8.3) ].

Risk of Seizure Advise patients about the potential risk of seizure. Advise patients to report any history of seizures or conditions that potentially lower the seizure threshold. [see Warnings and Precautions (5.4) ]. Important Administration Instructions Advise patients to take LYNKUET once daily at bedtime with water and swallow capsules whole.

Advise patients not to cut, crush or chew capsules [see Dosage and Administration (2.1) ]. Instruct patients requiring a dosage modification (i.e., one 60 mg capsule once daily) to partially peel back the foil covering the blister cell to expose only one of the two capsules. Instruct patients to store the remaining capsule in the original blister card in the carton until the next dose [see Storage and Handling (16.2) ].

Drug Interactions Advise patients to report their use of any other prescription or nonprescription medications or dietary supplements [see Drug Interactions (7.1) ].

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