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LEQSELVI deuruxolitinib phosphate 8 mg Tablet, Film Coated, 60-count — NDC 47335-0108-86 package photo

LEQSELVI deuruxolitinib phosphate 8 mg Tablet, Film Coated, 60-count

by Sun Pharmaceutical Industries, Inc. · 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)
NDC 47335-0108-86
🏷️ FDA NDC (as labeled) 47335-108-86 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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) 47335-108-86
Product NDC 47335-108
11-digit billing NDC 47335010886
NCPDP billing unit EA — each (per item)
RxCUI 2716563, 2716569
UNII 8VJ43S4LCM
UPC 0347335108866
Application # NDA217900
SPL Set ID a603f231-d09e-4bad-ad5e-b55f865da095
Established class (EPC) Janus Kinase Inhibitor; Organic Anion Transporter 3 Inhibitors
Mechanism of action Bile Salt Export Pump Inhibitors; Breast Cancer Resistance Protein Inhibitors; Janus Kinase Inhibitors; Multidrug and Toxin Extrusion Transporter 2 K Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-25
Route ORAL
Dosage form TABLET, FILM COATED
Substance DEURUXOLITINIB PHOSPHATE
GPI-14 90731020600320
GCN Seq No 086365
GCN 56071
HICL code 049773
Ingredient (HICL) Deuruxolitinib Phosphate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2Z
Therapeutic class — specific (HIC3) Janus Kinase (Jak) Inhibitors
AHFS code 84:06.16.00
AHFS class Janus Kinase Inhibitors (84:06)
FDB label name LEQSELVI 8 MG TABLET
FDB brand name Leqselvi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 47335-108-86 — 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 → 47335-0108-86. 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 Janus Kinase Inhibitor class.

Pharmacologic class Janus Kinase Inhibitor
Drug family (ATC) Janus-associated kinase (JAK) inhibitors
How it works Organic Anion Transporter 3 Inhibitors, Breast Cancer Resistance Protein Inhibitors, Janus Kinase Inhibitors, Bile Salt Export Pump 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationNDA217900 (NDA)
Labeler code47335
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio889 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 LEQSELVI 8 MG TABLET Ingredient Deuruxolitinib Phosphate
📖 What it is MedlinePlus · NLM

Deuruxolitinib is used for treatment of alopecia areata (a disease that causes sudden hair loss). Deuruxolitinib is in a class of medications called kinase inhibitors. It works by decreasing the activity of the immune system. How it works to help stop hair loss in individuals with alopecia areata is not well understood.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Leqselvi (deuruxolitinib) is a medication that calms the part of your immune system that's mistakenly attacking your hair follicles — which is what happens in severe alopecia areat...
  • What exactly is Leqselvi and what is it supposed to do for my hair loss?
  • Leqselvi is broken down in your body by a liver enzyme called CYP2C9. Some people are born with a version of this gene that makes the enzyme work much more slowly — they're called...
  • Why do I need a genetic test before I can start this medication?
📖 Read our full Deuruxolitinib 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 Purple
ShapeRound
ImprintC;8
Size7 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.

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

Inactive ingredient FAQ

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

💲 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 $75.43 $4,525.97 / 60 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
Leqselvi 8 mgthis 47335-0108-86 Sun 60 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
First FDA approval
Jul 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2044
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 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 25, 2024 RLD RS ⏳ ~18.1 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 12285432 — method of use (U-3976)
US 12364699 — method of use (U-3976)
US 11919907 — method of use (U-3976)
US 10561659 — method of use (U-3976)
US 12076323 — method of use (U-3976)
US 12247034 — drug substance
Exclusivity NCE
2024 2026 2028 2030 2032 2034 2036 2038 2040 2042 2044
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 12285432 ↗ Method of use U-3976 Aug 11, 2042
US 12364699 ↗ Method of use U-3976 Oct 10, 2044
US 11919907 ↗ Method of use U-3976 May 21, 2041
US 10561659 ↗ Method of use U-3976 May 4, 2037
US 12076323 ↗ Method of use U-3976 May 4, 2037
US 12247034 ↗ Drug substance — May 10, 2044
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Jul 25, 2029
Common questions
Is there a generic version of LEQSELVI 8 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LEQSELVI 8 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 2044 — 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 Leqselvi — 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 Leqselvi. 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
$294.9K
Claims incl. refills
63
Beneficiaries
26
Spend / beneficiary
$11,343.62
Spend / claim
$4,681.49
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 Marketing startStatus
47335-0108-86 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86) 2025-06-25 Active

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 47335-108-86, 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: 47335-0108-86, written without dashes as 47335010886. 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 47335-0108-86, the first segment (47335) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (0108) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (86) 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 Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, 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.
🚨 Boxed Warning 🎯 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 📋 Description 💬 Information for Patients 💬 Patient Medication Information
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS Increased risk of serious bacterial, fungal, viral and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. LEQSELVI treatment is not recommended in patients with active tuberculosis.

Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death, was observed with another Janus kinase (JAK) inhibitor vs.

TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies were reported in patients treated with LEQSELVI.

Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs.

TNF blockers in RA patients. ( 5.4 ) Thrombosis, including cerebral venous sinus thrombosis (CVT), deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs.

TNF blockers. ( 5.5 ) WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB), that may lead to hospitalization or death.

Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients.

( 5.2 ) Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.

( 5.3 ) Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. ( 5.4 ) Thrombosis has occurred in patients treated with LEQSELVI.

Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 )

🎯 Indications and Usage 84 words ▾

1 INDICATIONS AND USAGE LEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. LEQSELVI is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata.

( 1 ) Limitations of Use: LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For recommended testing, evaluations, and procedures prior to and during LEQSELVI treatment, see Full Prescribing Information. ( 2.1 ) Recommended dosage is 8 mg twice daily. ( 2.2 ) For treatment interruption for certain adverse reactions, see Full Prescribing Information. ( 2.3 )

2.1Recommended Evaluations and Immunizations Prior to and During Treatment Perform the following prior to treatment with LEQSELVI: CYP2C9 genotype determination: Test patients for CYP2C9 variants to determine CYP2C9 genotype. LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers (patients with decreased cytochrome P450 (CYP) 2C9 function) [see Contraindications ( 4 )] . An FDA-cleared or -approved test for the detection of CYP2C9 variants to direct the use of LEQSELVI is not currently available.

Evaluation for use of concomitant CYP2C9 inhibitors: LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] . Active and latent tuberculosis (TB) evaluation: LEQSELVI treatment is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk of TB, start preventive therapy for TB prior to LEQSELVI treatment [ see Warnings and Precautions ( 5.1 ) ].

Viral hepatitis screening in accordance with clinical guidelines: LEQSELVI treatment is not recommended in patients with active hepatitis B or hepatitis C. Hepatitis B infection screening: If hepatitis B infection is discovered, follow hepatitis B clinical guidelines, or refer to a liver specialist. Monitor patients for reactivation in accordance with clinical guidelines during treatment [ see Warnings and Precautions ( 5.1 ) ].

Complete blood count (CBC): LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm 3 absolute neutrophil count (ANC) <1,000 cells/mm 3 , or hemoglobin level <8 g/dl. Monitor complete blood counts periodically during treatment and modify dosage as recommended [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.8 )] . Complete any necessary immunizations, including herpes zoster vaccinations, according to current immunization guidelines prior to LEQSELVI treatment [see Warnings and Precautions ( 5.9 )] .

2.2Recommended Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food [see Clinical Pharmacology ( 12.3 )] . If a dose is missed, skip the missed dose and resume dosing at the next scheduled dose.

2.3Treatment Interruption and Resumption Serious or Opportunistic Infections If a patient develops a serious or opportunistic infection, interrupt LEQSELVI treatment until the infection is controlled [see Warnings and Precautions ( 5.1 )] . Hematological Abnormalities Recommendations for LEQSELVI treatment interruption for hematologic abnormalities are described in Table 1 [see Warnings and Precautions ( 5.9 )] . Table 1: Recommendations for LEQSELVI Treatment Interruption for Hematologic Abnormalities and Resumption Laboratory Measure Interruption Criterion Resumption Criterion Absolute Lymphocyte Count (ALC) <500 cells/mm 3 ≥500 cells/mm 3 Absolute Neutrophil Count (ANC) <1000 cells/mm 3 ≥1000 cells/mm 3 Hemoglobin <8 g/dL ≥8 g/dL

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablet: purple, round, debossed with “C” on one side and “8” on the other side Tablets: 8 mg. ( 3 )

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS LEQSELVI is contraindicated in patients who: Are CYP2C9 poor metabolizers [see Warnings and Precautions ( 5.6 )] . Are on concomitant moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] . LEQSELVI is contraindicated in patients: Who are CYP2C9 poor metabolizers. ( 4 ) Using moderate or strong CYP2C9 inhibitors. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Increased Risk of LEQSELVI-Associated Serious Adverse Reactions in CYP2C9 Poor Metabolizers or with Concomitant Use of Moderate or Strong CYP2C9 Inhibitors : LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor. ( 5.6 ) Gastrointestinal Perforations: Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms.

( 5.7 ) Hypoglycemia in Patients with Diabetes: Consider increased monitoring of blood glucose; advise patients with diabetes to contact their healthcare provider if they experience signs or symptoms consistent with hypoglycemia. ( 5.8 ) Lipid Elevations, Anemia, Neutropenia, and Lymphopenia: Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. ( 5.9 ) Immunizations: Avoid use of live vaccines during or immediately prior to LEQSELVI treatment.

( 5.10 )

5.1Serious Infections Serious infections have been reported in subjects with alopecia areata receiving LEQSELVI [see Adverse Reactions ( 6.1 )] . Avoid use of LEQSELVI in patients with an active, serious infection including localized infections. Prior to LEQSELVI treatment, consider the risks and benefits in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or opportunistic infection who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LEQSELVI.

If the patient develops a serious infection, interrupt treatment with LEQSELVI until the infection resolves or is adequately treated. If a patient develops a new infection during treatment with LEQSELVI, initiate complete diagnostic testing appropriate for an immunocompromised patient and appropriate antimicrobial therapy. Tuberculosis Evaluate patients for latent and active tuberculosis (TB) infection prior to LEQSELVI treatment.

LEQSELVI is not recommended for use in patients with active TB. Treat patients with latent TB before LEQSELVI treatment. Consider anti-TB therapy prior to LEQSELVI treatment in patients with previously untreated latent TB or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.

Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. Monitor patients receiving LEQSELVI for signs and symptoms of active TB during treatment, including patients who tested negative for latent TB infection prior to treatment. Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) were reported in clinical trials with LEQSELVI [see Adverse Reactions ( 6.1 )] .

If a patient develops herpes zoster, consider interrupting LEQSELVI treatment until the episode resolves. The impact of LEQSELVI on chronic viral hepatitis reactivation is unknown. Subjects with positive results for hepatitis B surface antigens (HBsAg), antibodies to hepatitis B core antigens (anti-HBc), or hepatitis C virus (HCV) with detectable HCV RNA at screening were excluded from LEQSELVI clinical trials.

Perform screening for viral hepatitis before treatment with LEQSELVI. LEQSELVI is not recommended for use in patients with active hepatitis B or hepatitis C (HCV RNA detected). If non-active hepatitis B infection is discovered, monitoring for reactivation or prophylactic treatment is recommended.

Follow hepatitis B clinical guidelines or refer to a liver specialist. Hepatitis B viral load (HBV-DNA titer) increase, with or without associated elevations in alanine aminotransferase and aspartate amin…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Gastrointestinal perforations [see Warnings and Precautions ( 5.7 )] Lipid Elevations, Anemia, Neutropenia and Lymphopenia [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (≥1%) are: headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LEQSELVI was evaluated in three randomized, placebo-controlled clinical trials (including a dose-ranging trial), two open-label trials, and two long-term extension trials in adult subjects with severe alopecia areata.

These subjects had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than six months. A total of 1,730 subjects with alopecia areata were treated across all trials, representing 1,962.9 patient-years of exposure. There were 974 subjects who were exposed to either LEQSELVI 8 mg or deuruxolitinib 12 mg for at least 1 year and 104 subjects who were exposed for at least 3 years.

Deuruxolitinib 12 mg is not approved. Among 1,020 subjects enrolled in the placebo-controlled clinical trials, 640 subjects received LEQSELVI 8 mg twice daily, 380 subjects received deuruxolitinib 12 mg twice daily and 299 subjects received placebo twice daily for up to 24 weeks [see Clinical Studies ( 14 )] . Adverse Reactions occurring at ≥1% in the LEQSELVI 8 mg or deuruxolitinib 12 mg twice daily group and at a higher rate than in the placebo group are presented in Table 2 .

A total of 20 (3.1%) of subjects treated with LEQSELVI 8 mg were discontinued from the trials due to adverse reactions. Table 2: Adverse Reactions Reported in ≥1% of Subjects with Alopecia Areata Treated with LEQSELVI 8 mg Twice Daily or Deuruxolitinib 12 mg Twice Daily (and More Frequently than Placebo) in Placebo-Controlled Trials Over 24-Weeks a. %-study size adjusted percentages. b. Acne includes: acne, dermatitis acneiform, and acne pustular. c.

Hyperlipidemia includes: blood cholesterol increased, low density lipoprotein increased, blood triglycerides increased, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, and dyslipidaemia. d. Fatigue includes: fatigue, asthenia, hypersomnia, somnolence, and lethargy. e. Skin and soft issue infections includes: folliculitis, impetigo, skin infection, subcutaneous abscess, furuncle, paronychia, and pustule. f.

Anemia includes: anemia, hematocrit decreased, hemoglobin decreased, iron deficiency anemia, and red blood cell count decreased. g. Neutropenia includes: neutropenia and neutrophil count decreased. h. Thrombocytosis includes: thrombocytosis and platelet count increased. i.

Herpes includes: oral herpes, herpes simplex, genital herpes simplex, and nasal herpes. Placebo N = 299 n (%) a LEQSELVI 8 mg twice daily N = 640 n (%) a Deuruxolitinib 12 mg twice daily N = 380 n (%) a Acne b 13 (4.3) 66 (10.0) 52 (12.6) Headache 30 (9.4) 83 (12.4) 44 (10.5) Nasopharyngitis 21 (6.7) 54 (8.1) 33 (7.7) Blood creatine phosphokinase increased 7 (2.2) 35 (5.3) 27 (7.4) Hyperlipidemia c 10 (3.1) 30 (4.4) 19 (5.2) Fatigue d 12 (3.9) 26 (3.9) 20 (4.9) Skin and soft tissue infections e 2 (0.8) 11 (1.6) 15 (4.0) Anemia f 3 (…

🔄 Drug Interactions 158 words ▾

7 DRUG INTERACTIONS Effect of Other Drugs on LEQSELVI Strong CYP3A and moderate or strong CYP2C9 inducers: Avoid concomitant use of LEQSELVI with strong CYP3A and moderate or strong CYP2C9 inducers. Deuruxolitinib is a CYP2C9 and CYP3A substrate. Concomitant use with a strong CYP3A and moderate or strong CYP2C9 inducer decreases deuruxolitinib exposure (C max and AUC), which may reduce LEQSELVI efficacy [see Clinical Pharmacology ( 12.3 )] .

Moderate or strong CYP2C9 inhibitors: LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors [see Contraindications ( 4 )] . Deuruxolitinib is a CYP2C9 substrate. Concomitant use with a moderate or strong CYP2C9 inhibitor is estimated to increase deuruxolitinib exposure (C max and AUC), which may increase the risk of LEQSELVI serious adverse reactions such as thrombosis [see Clinical Pharmacology ( 12.3 )] .

Strong CYP3A4 and moderate or strong CYP2C9 inducers: Avoid concomitant use. ( 7 ) Moderate or strong CYP2C9 inhibitors: Contraindicated. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. ( 8.2 ) Severe renal impairment: Not recommended. ( 8.6 ) Severe hepatic impairment: Not recommended. ( 8.7 )

8.1Pregnancy Risk Summary Based on the findings from animal reproduction studies, deuruxolitinib may cause fetal harm during pregnancy. Available data from pregnancies reported in clinical trials with LEQSELVI are not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of deuruxolitinib to pregnant rats during the period of organogenesis at a dose 4.8 times the maximum recommended human dose (MRHD) resulted in reduced fetal weight and increased skeletal malformation.

Oral administration of deuruxolitinib to pregnant rabbits during the period of organogenesis at a dose 0.3 times the MRHD resulted in maternal toxicity, reduced fetal weight, and increased post-implantation loss. Oral administration of deuruxolitinib to pregnant rats during pregnancy and lactation periods at a dose 5 times the MRHD resulted in maternal toxicity, decreased pup survival, and adverse effects on postnatal development (see Data ) . Advise pregnant women of the potential risk to a fetus.

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects is 2 to 4% of the general population and miscarriage occurs in 15 to 20% of clinically recognized pregnancies.

Data Animal Data In an embryo-fetal development study, deuruxolitinib was administered to pregnant rats during the period of organogenesis at oral doses of 15, 30, and 60 mg/kg/day. Reduced fetal weight and increased fetal skeletal malformation were noted at 60 mg/kg/day (4.8 times the MRHD based on AUC comparison) with no maternal toxicity. No embryo-fetal toxicity was observed at doses up to 30 mg/kg/day (equivalent to MRHD based on AUC comparison).

In another embryo-fetal development study, deuruxolitinib was administered to pregnant rabbits during the period of organogenesis at oral doses of 6, 30, and 60 mg/kg/day. Reduced fetal weight and increased post-implantation loss were noted at 60 mg/kg/day (0.3 times the MRHD based on AUC comparison), at which maternal toxicity was observed. No embryo-fetal toxicity was noted at doses up to 30 mg/kg/day (0.05 times the MRHD based on AUC comparison).

In a pre- and postnatal development study in rats, deuruxolitinib was administered to pregnant rats during pregnancy and lactation periods at oral doses of 15, 30, and 75 mg/kg/day. Decreases in liveborn pups and pup survival, decreased pup activity and lower pup body weights, and adverse effects on reproductive outcome in the second generation females (decreased corpora lutea, implantation, and number of live embryos, and increased resorption and post-implantation loss) were noted at 75 mg/kg/day (5 times the MRHD based on AUC comparison), at which maternal toxicity was also observed.

No adverse effects on pre- and postnatal development were noted at doses up to 30 mg/kg/day (0.8 times the MRHD based on AUC comparison).

8.2Lactation Risk Summary There are no data on the presence of deuruxolitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Deuruxolitinib was present in the milk of lactating rats (see Data ) . When a drug is present in animal milk, it is likely that the drug will be present in human milk.

Because of the potential for serious adverse reactions in nursing infants, advise women not to breastfeed during treatment with LEQSELVI and for one day after the last dose (approximately 5 to 6 elimination half-lives). Data Animal Data Following a single oral dose of 10 mg/kg administered to lactating rats on lactation day 14, deuruxolitinib concentra…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on the findings from animal reproduction studies, deuruxolitinib may cause fetal harm during pregnancy. Available data from pregnancies reported in clinical trials with LEQSELVI are not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of deuruxolitinib to pregnant rats during the period of organogenesis at a dose 4.8 times the maximum recommended human dose (MRHD) resulted in reduced fetal weight and increased skeletal malformation.

Oral administration of deuruxolitinib to pregnant rabbits during the period of organogenesis at a dose 0.3 times the MRHD resulted in maternal toxicity, reduced fetal weight, and increased post-implantation loss. Oral administration of deuruxolitinib to pregnant rats during pregnancy and lactation periods at a dose 5 times the MRHD resulted in maternal toxicity, decreased pup survival, and adverse effects on postnatal development (see Data ) . Advise pregnant women of the potential risk to a fetus.

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects is 2 to 4% of the general population and miscarriage occurs in 15 to 20% of clinically recognized pregnancies.

Data Animal Data In an embryo-fetal development study, deuruxolitinib was administered to pregnant rats during the period of organogenesis at oral doses of 15, 30, and 60 mg/kg/day. Reduced fetal weight and increased fetal skeletal malformation were noted at 60 mg/kg/day (4.8 times the MRHD based on AUC comparison) with no maternal toxicity. No embryo-fetal toxicity was observed at doses up to 30 mg/kg/day (equivalent to MRHD based on AUC comparison).

In another embryo-fetal development study, deuruxolitinib was administered to pregnant rabbits during the period of organogenesis at oral doses of 6, 30, and 60 mg/kg/day. Reduced fetal weight and increased post-implantation loss were noted at 60 mg/kg/day (0.3 times the MRHD based on AUC comparison), at which maternal toxicity was observed. No embryo-fetal toxicity was noted at doses up to 30 mg/kg/day (0.05 times the MRHD based on AUC comparison).

In a pre- and postnatal development study in rats, deuruxolitinib was administered to pregnant rats during pregnancy and lactation periods at oral doses of 15, 30, and 75 mg/kg/day. Decreases in liveborn pups and pup survival, decreased pup activity and lower pup body weights, and adverse effects on reproductive outcome in the second generation females (decreased corpora lutea, implantation, and number of live embryos, and increased resorption and post-implantation loss) were noted at 75 mg/kg/day (5 times the MRHD based on AUC comparison), at which maternal toxicity was also observed.

No adverse effects on pre- and postnatal development were noted at doses up to 30 mg/kg/day (0.8 times the MRHD based on AUC comparison).

🧒 Pediatric Use 16 words ▾

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

🧓 Geriatric Use 53 words ▾

8.5Geriatric Use Of the 600 subjects treated with LEQSELVI 8 mg in phase 3 clinical trials, 2 (0.3%) were 65 years of age or older. Clinical trials of LEQSELVI did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

🆘 Overdosage 57 words ▾

10 OVERDOSAGE There is no experience regarding human overdose with LEQSELVI. There is no specific antidote for overdose with LEQSELVI. Treatment should be symptomatic and supportive and monitor patients for signs and symptoms of adverse reactions [see Adverse Reactions ( 6.1 )] . In case of overdose, consider contacting the Poison Center at 1-800-222-1222 for latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Deuruxolitinib is a Janus kinase (JAK) inhibitor. JAKs mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression.

In an in vitro kinase activity assay, deuruxolitinib had greater inhibitory potency for JAK1, JAK2 and TYK2 relative to JAK3. The relevance of inhibition of JAK enzymes to therapeutic effectiveness is not currently known.

12.2Pharmacodynamics Deuruxolitinib Inhibition of IL-6 Induced STAT3 Phosphorylation Deuruxolitinib inhibited whole blood IL-6 stimulated pSTAT3 in healthy subjects 2 hours post-dose. The relevance of this finding in patients is unknown. Cardiac Electrophysiology At concentrations approximately 4-fold higher than the C max associated with the highest dose evaluated clinically, 12 mg twice-daily, deuruxolitinib does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Following oral administration of deuruxolitinib, C max and AUCs increased dose proportionally over a dose range from 8 mg to 48 mg (6 times the approved recommended dosage) in healthy subjects. Steady-state plasma concentrations were achieved within 1 to 2 days, with minimal accumulation, after twice daily administration. Absorption Deuruxolitinib bioavailability is 90%, with peak plasma concentrations reached within 1.5 hrs.

Effect of Food No clinically significant differences in the pharmacokinetics of deuruxolitinib were observed following administration of a high fat, high calorie meal (approximately 50% fat and 800-1000 calories). Distribution The deuruxolitinib steady state volume of distribution is approximately 50L. Deuruxolitinib plasma protein binding is 91.5% and blood to plasma concentration ratio is approximately 1.3.

Elimination The deuruxolitinib mean elimination half-life is approximately 4 hrs. Metabolism Deuruxolitinib is primarily metabolized by CYP2C9 (76%) and CYP3A4 (21%) and to a lesser extent by CYP1A2 (3%). The two most abundant human metabolites C-21714 and C-21717, each of which accounted for approximately 5% of total drug-related AUC and both are approximately 10-fold less pharmacologically active than deuruxolitinib.

Excretion After a single dose of radiolabeled deuruxolitinib, there was no unchanged dose recovered in either urine or feces. Specific Populations No clinically significant differences in the pharmacokinetics of deuruxolitinib were observed based on race [White (75%), African American (17%) and Asian (6%)], ethnicity [Hispanic or Latino (12%)], age (18-65 years), body weight (40.4-173 kg), mild to moderate renal impairment (eGFR 30-89 mL/min, MDRD), or mild to moderate hepatic impairment (Child Pugh A or B). The effect of severe renal impairment (eGFR < 30 mL/min, MDRD) or severe hepatic impairment (Child Pugh C) on deuruxolitinib pharmacokinetics is unknown.

Drug Interaction Studies Clinical Studies and Model-Informed Approaches Effect of Other Drugs on LEQSELVI Strong CYP3A4 and Moderate or strong CYP2C9 Inducers: Deuruxolitinib AUC decreased by 78% and C max by 41% following concomitant use of multiple doses of 600 mg rifampin (strong CYP3A4 and moderate CYP2C9 inducer) with a single dose of 12 mg deuruxolitinib (1.5 times the approved 8 mg dose). Strong CYP2C9 Inhibitors: Based on modeling, deuruxolitinib AUC is predicted to be increased by 200% and C max by 25% following concomitant use of multiple dosages of a strong CYP2C9 inhibitor with a single dose of 12 mg deuruxolitinib (1.5 times the approved 8 mg dose).

Moderate CYP2C9 Inhibitors: Deuruxolitinib AUC increased by 140% and C max by 21% following concomitant use of multiple dosages of 200 mg fluconazole (dual moderate CYP3A4 and CYP2C9 inhibitor) with a single dose o…

🧬 Mechanism of Action 95 words ▾

12.1Mechanism of Action Deuruxolitinib is a Janus kinase (JAK) inhibitor. JAKs mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression.

In an in vitro kinase activity assay, deuruxolitinib had greater inhibitory potency for JAK1, JAK2 and TYK2 relative to JAK3. The relevance of inhibition of JAK enzymes to therapeutic effectiveness is not currently known.

📦 How Supplied / Storage and Handling 98 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied: LEQSELVI tablets are packaged in white, high-density polyethylene (HDPE) bottles and closed with 24 mm white child-resistant caps with foil liner. Each bottle contains 1 g silica-gel canister. LEQSELVI is available as purple, round, immediate-release tablets debossed with “C” on one side and “8” on the other side: 8 mg: 60 tablets in a bottle; NDC: 47335-108-86 Storage and Handling: 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].

Store in the original bottle to protect from moisture.

📋 Description 146 words ▾

11 DESCRIPTION LEQSELVI (deuruxolitinib) tablets contain the phosphate salt of deuruxolitinib, a Janus kinase (JAK) inhibitor, for oral administration. Deuruxolitinib phosphate is a white to off-white crystalline solid with the chemical name 1 H -Pyrazole-1-propanenitrile, β-(cyclopentyl-2,2,3,3,4,4,5,5- d 8 )-4-(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)-, (β R )-, phosphate (1:1). Deuruxolitinib has high aqueous solubility at low pH.

Deuruxolitinib phosphate has a molecular weight of 412.42 g/mol and a molecular formula of C 17 H 13 D 8 N 6 O 4 P. The structural formula is: Each tablet contains 8 mg of deuruxolitinib (equivalent to 10.50 mg of deuruxolitinib phosphate) and the following excipients: colloidal silicon dioxide, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and povidone. The tablet film coating contains the following excipients: carmine, FD&C blue #2 aluminum lake, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ) Serious Infections Advise patients that they are more likely to develop infections when taking LEQSELVI. Advise patients that the risk of herpes zoster is increased in patients treated with LEQSELVI and some cases can be serious [see Warnings and Precautions ( 5.1 )] . Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions ( 5.1 )] .

Malignancies and Lymphoproliferative Disorders Inform patients that LEQSELVI may increase the risk of developing certain cancers, including skin cancers, and that periodic skin examinations should be performed while using LEQSELVI. Instruct patients to inform their healthcare provider if they have ever had any type of cancer [see Warnings and Precautions ( 5.3 )] . Major Adverse Cardiovascular Events Inform patients that LEQSELVI may increase the risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death.

Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions ( 5.4 )] . Thrombosis Advise patients that events of DVT, PE and CVT have been reported in clinical trials with LEQSELVI. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT, PE, or CVT [see Warnings and Precautions ( 5.5 )] .

Increased Risk of LEQSELVI-Associated Serious Adverse Reactions in CYP2C9 Poor Metabolizers or with Concomitant Use of Moderate or Strong CYP2C9 Inhibitors Advise patients to inform their healthcare providers of all medications they are taking, including prescription medicines, over-the-counter drugs, vitamins, and herbal products (e.g., St. John's wort) [see Warnings and Precautions ( 5.6 )] . Gastrointestinal Perforations Inform patients that gastrointestinal perforations have been reported in clinical trials with LEQSELVI.

Instruct patients to seek medical care immediately if they experience new onset of abdominal pain, fever, chills, nausea, or vomiting [see Warnings and Precautions ( 5.7 )] . Hypoglycemia in Patients with Diabetes Consider advising patients with diabetes to increase monitoring of blood glucose, since hypoglycemia, including severe hypoglycemia, has been reported after starting JAK inhibitors. Advise patients with diabetes to maintain appropriate awareness of blood glucose control during treatment and contact their healthcare provider(s) if they experience signs or symptoms consistent with hypoglycemia [see Warnings and Precautions ( 5.8 )] .

Laboratory Abnormalities Inform patients that LEQSELVI may affect certain lab tests, and that blood tests are required before and during LEQSELVI treatment [see Warnings and Precautions ( 5.9 )] . Immunizations Advise patients that vaccination with live vaccines is not recommended during or immediately prior to LEQSELVI treatment. Instruct patients to inform their healthcare practitioner that they are taking LEQSELVI prior to a potential vaccination [see Warnings and Precautions ( 5.10 )] .

Pregnancy Advise pregnant patients and patients of reproductive potential of the potential risk to a fetus and to inform their healthcare provider if they are pregnant or plan to become pregnant during treatment with LEQSELVI. Inform patients to report their pregnancy to Sun Pharmaceutical Industries, Inc at 1-800-818-4555 [see Use in Specific Populations ( 8.1 ) and ( 8.3 )] . Lactation Advise patients not to breastfeed during treatment with LEQSELVI and for one day after the last dose [see Use in Specific Populations ( 8.2 )] .

Manufactured for Sun Pharmaceutical Industries, Inc by: Halo Pharmaceutical, Inc, Whippany, NJ, 07981, USA U.S. Patent No. 10,561,659; 10,265,258; 11,298,570 and 11,919,907 LEQSELVI is a tr…

💬 Patient Medication Information ~3 min read ▾

MEDICATION GUIDE LEQSELVI ™ [ lek-sel-vee ] (deuruxolitinib) tablets, for oral use What is the most important information I should know about LEQSELVI? LEQSELVI may cause serious side effects, including: 1. Serious Infections.

LEQSELVI is a medicine that affects your immune system. LEQSELVI can lower the ability of your immune system to fight infections. Some people have had serious infections during treatment with LEQSELVI, caused by bacteria, fungi or viruses that can spread throughout the body.

Some people may die from these infections. Your healthcare provider should test you for TB before starting treatment with LEQSELVI. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with LEQSELVI.

You should not start taking LEQSELVI if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting LEQSELVI, tell your healthcare provider if you: are being treated for an infection. have an infection that does not go away or that keeps coming back. have diabetes, chronic lung disease, HIV, or a weak immune system.

People with these conditions have a higher chance for infections. have TB or have been in close contact with someone with TB. have had shingles (herpes zoster). have had hepatitis B or hepatitis C. live, or have lived, or have traveled to certain parts of the country (such as Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use LEQSELVI. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. think you have an infection or have symptoms of an infection such as: fever, sweating, or chills shortness of breath warm, red or painful skin or sores on your body burning when you urinate or urinating more often than normal muscle aches blood in your phlegm diarrhea or stomach pain cough weight loss feeling very tired After starting LEQSELVI, call your healthcare provider right away if you have any symptoms of an infection.

LEQSELVI can make you more likely to get infections or make any infections that you have worse. If you get a serious infection, your healthcare provider may stop your treatment with LEQSELVI until your infection is controlled. 2.

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. LEQSELVI is a JAK inhibitor medicine. 3.

Cancer and immune system problems. LEQSELVI may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in people taking LEQSELVI.

People taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment with LEQSELVI. Tell your healthcare provider if you have ever had any type of cancer.

4. Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Get emergency help right away if you get any symptoms of a heart attack or stroke during treatment with LEQSELVI, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortne…

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