Home › NDC Lookup › Ingredients › Sotagliflozin › 70183-0221-07
INPEFA sotagliflozin 200 mg Tablet, 7-count — NDC 70183-0221-07 package photo

INPEFA sotagliflozin 200 mg Tablet, 7-count

by Lexicon Pharmaceuticals, Inc. · 1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK
NDC 70183-0221-07
🏷️ FDA NDC (as labeled) 70183-221-07 billing pads the product segment with a zero
This package
Contains7-count Pack sizes3 compare ↓
Also priced by: Part D plans $20.10/unit — full pricing hub ↓
Also comes in: 10 tablets 70183-0221-31 30 tablets 70183-0221-30
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 3, 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) 70183-221-07
Product NDC 70183-221
11-digit billing NDC 70183022107
RxCUI 2638683, 2638689, 2638691, 2638693
UNII 6B4ZBS263Y
UPC 0370183241300, 0370183221302, 0300000000001
Application # NDA216203
SPL Set ID 1a46614e-05f6-421a-b6f4-d6f8760d643a
Established class (EPC) Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of action Sodium-Glucose Transporter 2 Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-26
Route ORAL
Dosage form TABLET
Substance SOTAGLIFLOZIN
GCN Seq No 084849
GCN 54239
HICL code 048976
Ingredient (HICL) Sotagliflozin
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4D
Therapeutic class — specific (HIC3) Antihyperglycemic-Sod/Gluc Cotransport2(Sglt2) Inh
AHFS code 68:20.18.00
AHFS class Sodium-Gluc Cotransport 2 (Sglt2) Inhib
FDB label name INPEFA 200 MG TABLET
FDB brand name Inpefa
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70183-221-07 — 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 → 70183-0221-07. 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 Sodium-Glucose Cotransporter 2 Inhibitor class.

Pharmacologic class Sodium-Glucose Cotransporter 2 Inhibitor
Drug family (ATC) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
How it works P-Glycoprotein Inhibitors, Sodium-Glucose Transporter 2 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.

🏭 Manufacturer & labeler

LabelerLexicon Pharmaceuticals, Inc.
Application holderLEXICON PHARMACEUTICALS INC
FDA applicationNDA216203 (NDA)
Labeler code70183
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio4 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 INPEFA 200 MG TABLET Ingredient Sotagliflozin
📖 What it is MedlinePlus · NLM

Sotagliflozin is used to reduce the risk of a stroke, heart attack, or death or hospitalization for heart failure or urgent visits for heart failure-related concerns in adults who have heart failure or type 2 diabetes or chronic kidney disease along with heart and blood vessel disease. Sotagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works to help heart failure by causing the kidneys to get rid of sodium and glucose which helps the heart to function better. It is unclear how it works to reduce risk of heart attack or stroke or death from...

Read the full MedlinePlus article ↗
1
Nutrient depletion considerations

Sotagliflozin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Sotagliflozin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 Blue / Yellow
ShapeOval
ImprintLEX;400
Size18 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII 5XDI2TS1EZ
    Microcrystalline cellulose is a refined plant fiber derived from wood pulp. It serves as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 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 $20.10 $140.73 / 7 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Inpefa 200 mg 70183-0220-07 Lexicon 7 tablets — — Discontinued —
Inpefa 200 mgthis 70183-0221-07 Lexicon 7 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

🏛️
2023
First FDA approval
May 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2030
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 Oct 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 26, 2023 RLD RS ⏳ ~4.1 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 8476413 — drug substance (U-3628)
US 8476413 — drug substance (U-3628)
US 7781577 — drug substance (U-3628)
US 7781577 — drug substance (U-3628)
US 8217156 — drug substance
US 8217156 — drug substance
Exclusivity NCE
Exclusivity NCE
2023 2025 2027 2029
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 8476413 ↗ Drug substance U-3628 May 29, 2028
US 8476413 ↗ Drug substance U-3628 May 29, 2028
US 7781577 ↗ Drug substance U-3628 May 4, 2028
US 7781577 ↗ Drug substance U-3628 May 4, 2028
US 8217156 ↗ Drug substance — Oct 7, 2030
US 8217156 ↗ Drug substance — Oct 7, 2030
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)May 26, 2028
NCENew Chemical Entity (5-year)May 26, 2028
Common questions
Is there a generic version of INPEFA 200 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for INPEFA 200 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2030 — 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets70183-0221-30 695 Rx · $532,223
10 tablets70183-0221-31 60 Rx · $62,238
7 tablets this page70183-0221-07 No Medicaid data
Drug total (last 4 qtrs): 755 Rx · 29,538 units · $594,462 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Inpefa — 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 Inpefa. 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
$1.2M
Claims incl. refills
1.5K
Beneficiaries
791
Spend / beneficiary
$1,514.13
Spend / claim
$825.98
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for INPEFA (this brand).

Top reported reactions

Dizziness52
Diarrhoea48
Death41
Therapy Interrupted35
Dyspnoea27
Urinary Tract Infection25
Headache23

Age at onset

Adult4
Elderly7

Reporter sex

541 reports
Male · 51%
Female · 49%

Serious outcomes

Hospitalization103
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 296 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70183-0221-07 You're viewing this 1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK — — 2024-01-15 Active
70183-0221-31 1 BLISTER PACK in 1 CARTON (70183-221-31) / 3 BLISTER PACK in 1 BLISTER PACK / 10 TABLET in 1 BLISTER PACK $20.46 / ea $613.80 2023-12-01 Active
70183-0221-30 30 TABLET in 1 BOTTLE (70183-221-30) $20.46 / ea $613.80 2024-03-01 Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 70183-0221-07?
NDC 70183-0221-07 is a 7-count package — 1 blister pack in 1 carton / 7 tablet in 1 blister pack.
What is the difference between NDC 70183-0221-07 and NDC 70183-0221-30?
Both are INPEFA sotagliflozin 200 mg Tablet — the drug itself is identical. NDC 70183-0221-07 is the 7-count package, while NDC 70183-0221-30 is the 30 tablets package.
What NDC number is used to bill for this package of INPEFA sotagliflozin 200 mg Tablet?
Bill NDC 70183-0221-07 — the 11-digit billing format is 70183022107. 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 70183-221-07, 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: 70183-0221-07, written without dashes as 70183022107. 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 70183-0221-07, the first segment (70183) is the labeler code FDA assigned to Lexicon Pharmaceuticals, Inc.; the middle segment (0221) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Lexicon 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 10 tablets (70183-0221-31), 30 tablets (70183-0221-30). 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?
Lexicon 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 💬 Medication Guide
🎯 Indications and Usage 90 words ▾

1 INDICATIONS AND USAGE INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure ( 1 ) or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Correct volume status before starting INPEFA at 200 mg daily and titrate to 400 mg as tolerated. (2.2) In patients with decompensated heart failure, begin dosing when patients are hemodynamically stable. ( 2.1 ) Withhold INPEFA at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. ( 2.3 )

2.1Prior to Initiation of INPEFA Assess volume status and, if necessary, correct volume depletion prior to initiation of INPEFA [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.5 , 8.6 )] . Assess renal function prior to initiation of INPEFA and then as clinically indicated [see Warnings and Precautions ( 5.2 )] . For patients with decompensated heart failure, dosing may begin as soon as the patient is hemodynamically stable, including during hospitalization or urgent outpatient treatment or immediately upon discharge.

2.2Recommended Dosage The recommended starting dose of INPEFA is 200 mg orally once daily not more than one hour before the first meal of the day. Up-titrate after at least 2 weeks to 400 mg orally once daily as tolerated [see Clinical Studies ( 14 )] . Down-titrate to 200 mg as necessary [see Adverse Reactions ( 6.1 ), Warnings and Precautions ( 5 ) and Use in Specific Populations ( 8.6 )].

Swallow tablets whole. Do not cut, crush, or chew tablets. If a dose of INPEFA is missed by more than 6 hours, take the next dose as prescribed the next day.

2.3Temporary Interruption for Surgery Withhold INPEFA at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume INPEFA when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] .

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS INPEFA 200 mg tablet is an oval, blue, film-coated tablet debossed with “LEX” on one side and “200” on the other side. INPEFA 400 mg tablet is an oval, yellow, film-coated tablet debossed with “LEX” on one side and “400” on the other side. Tablets: 200 mg and 400 mg ( 3 )

⛔ Contraindications 26 words ▾

4 CONTRAINDICATIONS INPEFA is contraindicated in patients with a history of serious hypersensitivity reaction to INPEFA. History of serious hypersensitivity reaction to INPEFA. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue INPEFA if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.

( 5.1 ) Volume Depletion: Before initiating, correct volume status. Monitor for signs and symptoms of hypotension during therapy. ( 5.2 ) Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Lower dose of insulin or insulin secretagogue may be required.

( 5.4 ) Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections: Monitor patients for signs and symptoms of genitourinary infections and treat promptly, if indicated. Immediately evaluate patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, for necrotizing fasciitis and if suspected, discontinue INPEFA, and promptly institute appropriate medical and/or surgical intervention.

( 5.3 )

5.1Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, INPEFA significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate. In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium glucose cotransporter 2 (SGLT2) inhibitors compared to patients who received placebo; this risk may be greater with higher doses of INPEFA.

INPEFA is not indicated for glycemic control. Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using SGLT2 inhibitors.

Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include acute febrile illness, reduced caloric intake, ketogenic diet, surgery, insulin dose reduction, volume depletion, and alcohol abuse. Signs and symptoms are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Blood glucose levels at presentation may be below those typically expected for diabetic ketoacidosis (e.g., less than 250 mg/dL).

Ketoacidosis and glucosuria may persist longer than typically expected. Urinary glucose excretion persists for 3 days after discontinuing INPEFA [see Clinical Pharmacology ( 12.3 )]; however, there have been postmarketing reports of ketoacidosis and glucosuria lasting greater than 6 days and some up to 2 weeks after discontinuation of SGLT2 inhibitors. Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis if indicated by the clinical situation.

Assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis. If ketoacidosis is suspected, discontinue INPEFA, promptly evaluate, and treat ketoacidosis, if confirmed. Monitor patients for resolution of ketoacidosis before restarting INPEFA.

Withhold INPEFA, if possible, in temporary clinical situations that could predispose patients to ketoacidosis. Resume INPEFA when the patient is clinically stable and has resumed oral intake [see Dosage and Administration ( 2.3 )] . Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue INPEFA and seek medical attention immediately if signs and symptoms occur.

5.2 Volume Depletion INPEFA can cause intravascul…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions ( 5.1 )] Volume Depletion [see Warnings and Precautions ( 5.2 )] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections [see Warnings and Precautions ( 5.3 )] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lexicon at 1-855-330-2573 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. In the phase 3 (SOLOIST [see Clinical Studies ( 14.1 )] and SCORED [see Clinical Studies ( 14.2 )] ) placebo-controlled trials, 5,896 subjects received INPEFA. In the SOLOIST study, 336 patients (56%) reached the 400 mg dose.

In the SCORED study, 3,934 patients (74%) reached the 400 mg dose. In the SOLOIST study, 5.6% of patients in the INPEFA group and 5.4% of patients in the placebo group discontinued therapy due to adverse events (AEs). In the SCORED study, 5.0% of patients in the INPEFA group and 4.5% of patients in the placebo group discontinued therapy due to AEs.

Table 1 Adverse Reactions Reported in ≥ 2% of Patients Treated with INPEFA and Greater Than Placebo in Either SOLOIST or SCORED Adverse Reaction SOLOIST N = 1,216 SCORED N = 10,577 Placebo (%) N = 611 INPEFA (%) N = 605 Placebo (%) N = 5,286 INPEFA (%) N = 5,291 Urinary tract infection 7.2 8.6 11.0

11.5Volume depletion 8.8 9.3 4.0

5.2Diarrhea 4.1 6.9 6.0

8.4Hypoglycemia 2.8 4.3 7.9

7.7Dizziness 2.5 2.6 2.8

3.3Genital mycotic infection 0.2 0.8 0.9

2.4Changes in Laboratory Test Values During Treatment Increase in Serum Creatinine and Decrease in eGFR Initiation of SGLT2 inhibitors, including INPEFA, causes a small increase in serum creatinine and decrease in eGFR. These changes in serum creatinine and eGFR generally occur within 4 weeks of starting therapy and then stabilize regardless of baseline kidney function. Changes that do not fit this pattern should prompt further evaluation to exclude the possibility of acute kidney injury.

In studies that included patients with type 2 diabetes mellitus with moderate renal impairment, the acute effect on eGFR reversed after treatment discontinuation, suggesting acute hemodynamic changes may play a role in the renal function changes observed with INPEFA [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.6 )] .

🔄 Drug Interactions 159 words ▾

7 DRUG INTERACTIONS Digoxin : Monitor digoxin levels. ( 7.1 ) Uridine 5'-diphospho-glucuronosyltransferase Inducers (e.g., rifampin): Sotagliflozin exposure is reduced. Consider monitoring of clinical status. ( 7.2 ) Lithium: Monitor serum lithium concentrations. ( 7.3 )

7.1Digoxin There is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg. Patients taking INPEFA with concomitant digoxin should be monitored appropriately [see Clinical Pharmacology ( 12.3 )] .

7.2Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. The coadministration of rifampicin, an inducer of UGTs, with a single dose of 400 mg sotagliflozin resulted in a decrease in the exposure to sotagliflozin. This decrease in exposure to sotagliflozin may decrease efficacy [see Clinical Pharmacology ( 12.3 )] .

7.3Lithium Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during INPEFA initiation and dosage changes.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Advise females of the potential risk to a fetus especially during the second and third trimesters. ( 8.1 ) Lactation : INPEFA is not recommended when breastfeeding. ( 8.2 ) Geriatrics : Higher incidence of adverse reactions related to volume depletion. ( 5.2 , 8.5 ) Renal Impairment : Higher incidence of adverse reactions related to volume depletion. ( 5.2 , 8.6 )

8.1Pregnancy Risk Summary Based on animal data showing renal effects, INPEFA is not recommended during the second and third trimesters of pregnancy. Available data with INPEFA in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated heart failure in pregnancy [see Clinical Considerations ] .

In rats, renal changes were observed when sotagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Exposure approximately 5 times the clinical exposure at the maximum recommended human dose (MRHD) of 400 mg once daily caused increased kidney weights and renal pelvis and tubule dilatations that were partially reversible [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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. Clinical Considerations Disease-associated Maternal and/or Embryo-fetal Risk Pregnant women with congestive heart failure are at increased risk for preterm birth.

Clinical classification of heart disease may worsen with pregnancy and lead to maternal death. Data Animal Data In embryo-fetal development studies in rats and rabbits, sotagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. Sotagliflozin was not teratogenic when administered at doses up to 100 mg/kg/day in pregnant rats during embryonic organogenesis (40 times the human exposure at the MRHD).

Higher exposures (350 mg/kg or 161 times the human exposure at the MRHD) resulted in embryo-lethality, effects on fetal growth, and cardiovascular and skeletal fetal abnormalities commensurate with maternal toxicity. Sotagliflozin was not teratogenic when administered at doses up to 200 mg/kg/day in pregnant rabbits (9 times the human exposure at the MRHD). In a prenatal and postnatal development study in pregnant and lactating rats, sotagliflozin was administered at oral doses up to 100 mg/kg/day from gestation Day 6 through to lactation Day 20 (weaning).

An increased incidence of dilated kidneys with discoloration and dilated ureters was observed at doses ≥ 30 mg/kg (≥ 4 times the human exposure at the MRHD). Sotagliflozin did not adversely affect developmental landmarks, sexual maturation, or reproductive performance of the offspring at doses up to 40 times the human exposure at the MRHD. Sotagliflozin dosed directly to juvenile rats from postnatal Day (PND) 21 until PND 90 at doses of 3, 10, 30, and 75 mg/kg/day caused dose-related increased kidney weights for males given ≥ 10 mg/kg/day and females given ≥ 30 mg/kg/day and was correlated with renal tubular and pelvis dilation for animals given ≥ 30 mg/kg/day.

These findings were fully or partially reversed after a 29-day recovery period. These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimesters of human development.

8.2Lactation Risk Summary There are no data on the presence of INPEFA in human milk, the effects on the breastfed infant, or the effects on milk production. Sotagliflozin is present in rat milk (see Data ). When a drug is present in an…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on animal data showing renal effects, INPEFA is not recommended during the second and third trimesters of pregnancy. Available data with INPEFA in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated heart failure in pregnancy [see Clinical Considerations ] .

In rats, renal changes were observed when sotagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Exposure approximately 5 times the clinical exposure at the maximum recommended human dose (MRHD) of 400 mg once daily caused increased kidney weights and renal pelvis and tubule dilatations that were partially reversible [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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. Clinical Considerations Disease-associated Maternal and/or Embryo-fetal Risk Pregnant women with congestive heart failure are at increased risk for preterm birth.

Clinical classification of heart disease may worsen with pregnancy and lead to maternal death. Data Animal Data In embryo-fetal development studies in rats and rabbits, sotagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. Sotagliflozin was not teratogenic when administered at doses up to 100 mg/kg/day in pregnant rats during embryonic organogenesis (40 times the human exposure at the MRHD).

Higher exposures (350 mg/kg or 161 times the human exposure at the MRHD) resulted in embryo-lethality, effects on fetal growth, and cardiovascular and skeletal fetal abnormalities commensurate with maternal toxicity. Sotagliflozin was not teratogenic when administered at doses up to 200 mg/kg/day in pregnant rabbits (9 times the human exposure at the MRHD). In a prenatal and postnatal development study in pregnant and lactating rats, sotagliflozin was administered at oral doses up to 100 mg/kg/day from gestation Day 6 through to lactation Day 20 (weaning).

An increased incidence of dilated kidneys with discoloration and dilated ureters was observed at doses ≥ 30 mg/kg (≥ 4 times the human exposure at the MRHD). Sotagliflozin did not adversely affect developmental landmarks, sexual maturation, or reproductive performance of the offspring at doses up to 40 times the human exposure at the MRHD. Sotagliflozin dosed directly to juvenile rats from postnatal Day (PND) 21 until PND 90 at doses of 3, 10, 30, and 75 mg/kg/day caused dose-related increased kidney weights for males given ≥ 10 mg/kg/day and females given ≥ 30 mg/kg/day and was correlated with renal tubular and pelvis dilation for animals given ≥ 30 mg/kg/day.

These findings were fully or partially reversed after a 29-day recovery period. These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimesters of human development.

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use The safety and effectiveness of INPEFA in pediatric patients under 18 years of age have not been established.

🧓 Geriatric Use 164 words ▾

8.5Geriatric Use No INPEFA dosage change is recommended based on age. In the SOLOIST study, a total of 241 (40%) patients treated with INPEFA were between 65 and < 75 years of age, and 174 (29%) were ≥ 75 years of age. In the SCORED study, a total of 2,470 (47%) patients treated with INPEFA were between 65 and < 75 years of age, and 1,240 (23%) were ≥ 75 years of age.

No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension. In patients ≥ 65 years of age, a higher proportion of patients treated with INPEFA had adverse reactions of volume depletion [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 ) ].

🆘 Overdosage 54 words ▾

10 OVERDOSAGE There were no confirmed reports of symptomatic overdose with sotagliflozin during the clinical development program of INPEFA. In the event of an overdose with INPEFA, contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient's clinical status. The removal of sotagliflozin by hemodialysis has not been studied.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea.

The mechanism for sotagliflozin's cardiovascular benefits has not been established.

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, placebo-controlled, active-comparator, crossover study, 58 healthy subjects were administered a single oral dose of sotagliflozin 800 mg or sotagliflozin 2000 mg (5 times the maximum recommended dose), moxifloxacin, and placebo. No increase in QT corrected for heart rate (QTc) was observed with either 800 mg or 2000 mg sotagliflozin.

12.3Pharmacokinetics Plasma C max and AUC of sotagliflozin increased in a dose-proportional manner in the therapeutic dose range of 200 mg to 400 mg once daily. Accumulation of sotagliflozin was observed with an approximate 50-100% increase in both C max and area under the concentration-time curve from 0 to 24 hours (AUC 0-24h ) at steady state verses the first day of dosing. Absorption The absolute bioavailability of oral sotagliflozin 400 mg dose was approximately 25% (90% confidence interval [CI] 16% to 39%) for area under the concentration-time curve from time 0 to last measurable concentration (AUC 0-last ).

The contribution of enterohepatic circulation to the overall exposure is estimated to be approximately 50%. The median time to maximum plasma concentration (T max ) ranged from 1.25 to 3 hours, over a single-dose range of 200 mg to 2000 mg. Following administration of multiple doses (400 mg and 800 mg), the median T max values ranged from 2.5 to 4 hours.

Food Effect When sotagliflozin tablets were administered with a high-caloric breakfast compared to fasting conditions, plasma exposure to sotagliflozin as measured by C max and AUC 0-inf increased by 149% and 50%, respectively. Multiple doses of sotagliflozin 400 mg given immediately before breakfast, 30 minutes prior to breakfast, and 1-hour before breakfast in healthy subjects showed a consistent effect of sotagliflozin on urine glucose excretion (UGE), insulin, and postprandial glucose (PPG) across all dose schedules.

It is recommended that INPEFA be taken not more than one hour before the first meal of the day. Distribution Both sotagliflozin and its major human metabolite sotagliflozin 3-O-glucuronide exhibited high binding to human plasma proteins in vitro (> 93% bound), which was not dependent on the concentration of sotagliflozin and sotagliflozin 3-O-glucuronide and was not influenced by the degree of renal or hepatic function. Following administration of a single 400 mg dose of [ 14 C]-sotagliflozin, the mean blood/plasma ratios for total radioactivity were 0.5 and 0.4 for C max and AUC 0-last , respectively, and the mean whole blood to plasma concentration ratio of sotagliflozin ranged from 0.5 to 0.6.

The mean apparent volume of distribution of sotagliflozin following administration of a single 400 mg oral dose of [ 14 C]-sotagliflozin was 9000 L. Elimination Metabolism Following the administration of a single dose of 400 mg [ 14 C]-sotagliflozin in healthy subjects, sotagliflozin was extensively metabolized predominantly to sotagliflozin 3-O-glucuronide and it represented 94.3% of the radioactivity in plasma. The key enzymes responsible for the metabolism of sotagliflozin were UGT1A9 and, to a lesser extent, CYP3A4.

Following incubation of sotagliflozin with UGT1A9, the 3-O-glucuronide metabolite of sotagliflozin was the main conjugate observed. No acyl glucuronides of sotagliflozin were identified. Excretion Following the administration of a single dose of 400 mg [ 14 C]-sotagliflozin, 57% and 37% of the radioactivity was recovered in the urine and feces, respectivel…

🧬 Mechanism of Action 64 words ▾

12.1Mechanism of Action Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea.

The mechanism for sotagliflozin's cardiovascular benefits has not been established.

📦 How Supplied / Storage and Handling 72 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING INPEFA tablets are oval and film-coated. Debossed Tablets Strength (mg) Color Deboss Bottle/30 Blister/30 (3 x 10) 200 Blue LEX on one side, 200 on other side NDC 70183-221-30 NDC 70183-221-31 400 Yellow LEX on one side, 400 on other side NDC 70183-241-30 -- Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 23 words ▾

Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

📋 Description 135 words ▾

11 DESCRIPTION INPEFA tablets for oral administration contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The chemical name of sotagliflozin is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol. Its molecular formula is C 21 H 25 ClO 5 S and the molecular weight is 424.94.

The structural formula is: Sotagliflozin is a white to off-white solid. It is practically insoluble in water. Each film-coated tablet of INPEFA contains 200 mg or 400 mg of sotagliflozin and the following inactive ingredients.

The core of the tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating for the 200 mg tablet contains: indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide. The film coating for the 400 mg tablet contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide.

Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, inform them that using INPEFA can increase their risk of life-threatening diabetic ketoacidosis. For all other patients, inform them that INPEFA can cause potentially fatal ketoacidosis and that type 2 diabetes mellitus is a risk factor.

Educate all patients on precipitating factors (such as infection, reduced caloric intake, ketogenic diet, surgery, insulin dose reduction, dehydration, and alcohol abuse) and symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing). Inform patients that blood glucose may be normal even in the presence of ketoacidosis. Advise patients that they may be asked to monitor ketones.

If symptoms of ketoacidosis occur, instruct patients to discontinue INPEFA and seek medical attention immediately [see Warnings and Precautions ( 5.1 )] . Volume Depletion Inform patients that symptomatic hypotension may occur with INPEFA and advise them to contact their healthcare provider if they experience such symptoms [see Warnings and Precautions ( 5.2 )] . Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.

Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections Counsel patients that genitourinary infections may occur when taking INPEFA and may become serious. Educate patients on the symptoms and advise them to seek medical advice if symptoms occur. Specifically, advise patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise [see Warnings and Precautions ( 5.3 )] .

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Inform patients that the incidence of hypoglycemia is increased when INPEFA is used in combination with insulin and that a lower dose of insulin may be required to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions Inform patients that hypersensitivity reactions (e.g., urticaria, anaphylactic reactions, and angioedema) have been reported with other SGLT2 inhibitors. Advise patients to immediately report any signs or symptoms suggesting allergic reaction or angioedema and to discontinue the drug until they have consulted their prescribing physician.

Pregnancy Advise pregnant patients of the potential risk to a fetus with treatment with INPEFA. Instruct patients to immediately inform their healthcare provider if pregnant or planning to become pregnant [see Use in Specific Populations ( 8.1 )] . Lactation Advise patients that use of INPEFA is not recommended while breastfeeding [see Use in Specific Populations ( 8.2 )].

Laboratory Tests Due to its mechanism of action, patients taking INPEFA will test positive for glucose in their urine. Missed Dose If a dose of INPEFA is missed by more than 6 hours, take the next dose as prescribed the next day. Advise patients not to take two doses of INPEFA at the same time.

Manufactured for: Lexicon Pharmaceuticals, Inc. (The Woodlands, TX 77381) INPEFA is a registered trademark of Lexicon Pharmaceuticals, Inc.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued 08/2026 MEDICATION GUIDE INPEFA® (in peh' fah) (sotagliflozin) tablets, for oral use What is the most important information I should know about INPEFA?

INPEFA can cause serious side effects, including: Ketoacidosis (acidic blood with increased ketones in your blood or urine ). Ketoacidosis has happened in people who have type 1 or type 2 diabetes during treatment with INPEFA. Ketoacidosis can happen with INPEFA even if your blood sugar is not high.

Your healthcare provider may ask you to periodically check ketones in your urine or blood. Ketoacidosis can also happen in people who are sick or who have surgery during treatment with INPEFA. Ketoacidosis is a serious condition which needs to be treated in a hospital.

Ketoacidosis may lead to death. Stop taking INPEFA and call your healthcare provider or get medical help right away if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea vomiting trouble breathing stomach-area (abdominal) pain tiredness ketones in your urine or blood Dehydration.

INPEFA can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury due to dehydration in people with type 2 diabetes who are taking a medicine that works like INPEFA.You may be at higher risk of dehydration if you: take medicines to lower your blood pressure, including water pills (diuretics) are 65 years of age or older are on a low salt diet have kidney problems Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.

Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long. Genital and urinary tract infections. INPEFA can cause serious infections in your genital area or urinary tract that could require hospitalization.

A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This infection may require hospitalization, multiple surgeries, and could lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness swelling redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: Urinary tract infection: burning feeling when you urinate need to urinate often or right away pain in the lower part of your stomach (pelvis) blood in your urine You may also have a fever, back pain, nausea, or vomiting.

Vaginal yeast infection: vaginal odor white or yellowish vaginal discharge (may be lumpy or look like cottage cheese) vaginal itching Yeast infection of the skin around the penis (balanitis or balanoposthitis): If you are uncircumcised, swelling may make it difficult to pull back the skin around the tip of your penis. Other symptoms include: redness, itching, or swelling of the penis bad smelling discharge from the penis rash on the penis pain in the skin around the penis Talk to your healthcare provider about what to do if you get symptoms of a yeast infection.

They may suggest you use an over-the-counter antifungal medicine. Contact your healthcare provider right away if your symptoms do not improve after using an over-the-counter antifungal medicine. See “ What are the possible side effects of INPEFA? ” for more informat…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70183-0220-07 · Lexicon 70183-0241-30 · Lexicon →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.