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Olumiant baricitinib 1 mg Tablet, Film Coated, 30-count

by Eli Lilly and Company · 30 TABLET, FILM COATED in 1 BOTTLE (0002-4732-30)

NDC 00002-4732-30

🏷️ FDA NDC (as labeled) 0002-4732-30 billing pads the labeler segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 0002-4732-30

Product NDC 0002-4732

11-digit billing NDC 00002473230

NCPDP billing unit EA — each (per item)

RxCUI 2047241, 2047247, 2205472, 2205474, 2588561, 2601725

UNII ISP4442I3Y

UPC 0300024479302, 0300024182301, 0300024732308

Application # NDA207924

SPL Set ID 866e9f35-9035-4581-a4b1-75a621ab55cf

Established class (EPC) Janus Kinase Inhibitor

Mechanism of action Janus Kinase Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-10-08

Route ORAL

Dosage form TABLET, FILM COATED

Substance BARICITINIB

GPI-14 66603010000310

GCN Seq No 080389

GCN 47205

HICL code 044296

Ingredient (HICL) Baricitinib

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 90:24.12.92

AHFS class Janus Kinase Inhibitors, Miscellaneous

FDB label name OLUMIANT 1 MG TABLET

FDB brand name Olumiant

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 0002-4732-30 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00002-4732-30. 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 Janus Kinase 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

LabelerEli Lilly and Company

Application holderELI LILLY AND CO

FDA applicationNDA207924 (NDA)

Labeler code00002

First marketedOct 2019

Product typeHuman Prescription Drug

Portfolio192 products on file

🔎 All NDCs from Eli Lilly and Company

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 OLUMIANT 1 MG TABLET Ingredient Baricitinib

📖 What it is MedlinePlus · NLM

Baricitinib is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s). It is also used for the treatment of coronavirus disease 2019 (COVID-19 infection) in hospitalized adults who require supplemental oxygen, a ventilator, or who need extracorporeal membrane oxygenation (ECMO; a device that adds oxygen to the blood). Baricitinib is also used to treat alopecia areata (a condition in...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Olumiant works by blocking overactive signals inside your immune cells that cause inflammation. Depending on what you're being treated for, this can help calm the joint inflammatio...
What exactly does Olumiant do, and why was I prescribed it?
You can take Olumiant with or without food — it doesn't matter much either way. It's usually taken once a day, so try to take it at the same time each day to stay consistent. If yo...
Do I need to take it with food, and what if I miss a dose?

📖 Read our full Baricitinib guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Baricitinib — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Baricitinib (59 interactions) — ranked by severity →

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 pink

ShapeRound

ImprintLilly;4

Size9 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 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII 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 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 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 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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 system	Per each	Per 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	$95.19	$2,855.61 / 30 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Olumiant 1 mgthis 00002-4732-30	Eli	30 tablets	—	AB	FDA listed	—

About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.

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

🏛️

2022

First FDA approval

May 2022

📍

2026

Currently FDA-listed

4 years listed

🛡️

2032

Latest patent/protection listed

not a guaranteed launch date

🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved May 10, 2022 AB TE-rated RLD RS ⏳ ~6.2 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 9089574 — method of use (U-3372)

US 11045474 — method of use (U-3372)

US 9737469 — method of use (U-3500)

US 11045474 — method of use (U-3372)

US 9089574 — method of use (U-3372)

US 8420629 — method of use (U-247)

US 11806555 — method of use (U-3500)

US 8158616 — drug substance

2022 2024 2026 2028 2030 2032

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

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

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

Listed patents (17)

Patent	Type	Use code	Expires
US 9089574 ↗	Method of use	U-3372	Nov 30, 2032
US 11045474 ↗	Method of use	U-3372	Nov 30, 2032
US 9737469 ↗	Method of use	U-3500	Nov 2, 2031
US 9737469 ↗	Method of use	U-3500	Nov 2, 2031
US 9737469 ↗	Method of use	U-3500	Nov 2, 2031
US 11045474 ↗	Method of use	U-3372	Nov 30, 2032
US 11045474 ↗	Method of use	U-3372	Nov 30, 2032
US 9089574 ↗	Method of use	U-3372	Nov 30, 2032
US 9089574 ↗	Method of use	U-3372	Nov 30, 2032
US 8420629 ↗	Method of use	U-247	Mar 10, 2029
US 8420629 ↗	Method of use	U-247	Mar 10, 2029
US 11806555 ↗	Method of use	U-3500	Nov 2, 2031
US 11806555 ↗	Method of use	U-3500	Nov 2, 2031
US 11806555 ↗	Method of use	U-3500	Nov 2, 2031
US 8158616 ↗	Drug substance	—	May 31, 2032
US 8158616 ↗	Drug substance	—	May 31, 2032
US 8158616 ↗	Drug substance	—	May 31, 2032

Common questions

Is there a generic version of OLUMIANT 1 MG TABLET?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for OLUMIANT 1 MG TABLET. See the alternatives section for substitutable, lower-cost products.

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 Olumiant — 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 Olumiant. 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

$12.54M

Claims incl. refills

3.1K

Beneficiaries

1.4K

Spend / beneficiary

$8,939.91

Spend / claim

$4,023.96

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 Olumiant (this brand).

Top reported reactions

Covid-19449

Rheumatoid Arthritis355

Pulmonary Embolism309

Pneumonia282

Headache265

Herpes Zoster239

Death237

Age at onset

Neonate6

Infant7

Child63

Adolescent39

Adult1,372

Elderly752

Reporter sex

Male · 33%

Female · 67%

Unknown · 0%

Serious outcomes

Hospitalization3,139

Death877

Life-threatening583

Disabling186

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
00002-4732-30 You're viewing this	30 TABLET, FILM COATED in 1 BOTTLE (0002-4732-30)	2019-10-08	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)	✓ 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 0002-4732-30, 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: 00002-4732-30, written without dashes as 00002473230. 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 00002-4732-30, the first segment (00002) is the labeler code FDA assigned to Eli Lilly and Company; the middle segment (4732) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Eli Lilly and Company. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Eli Lilly and Company 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~3 min read ▾

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS 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 leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled.

OLUMIANT should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; 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. ( 5.2 ) Malignancies have occurred in patients treated with OLUMIANT.

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 JAK inhibitor vs.

TNF blockers in RA patients. ( 5.4 ) Thrombosis has occurred in patients treated with OLUMIANT. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs.

TNF blockers. ( 5.5 ) SERIOUS INFECTIONS Patients treated with OLUMIANT are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Most patients with rheumatoid arthritis who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt OLUMIANT until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. OLUMIANT should not be given to patients with active tuberculosis.

Patients, except those with COVID-19, should be tested for latent tuberculosis before initiating OLUMIANT and during therapy. If positive, start treatment for latent infection prior to OLUMIANT use. Invasive fungal infections, including candidiasis and pneumocystosis.

Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral, and other infections due to opportunistic pathogens. The risks and benefits of treatment with OLUMIANT should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OLUMIANT including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions ( 5.1 )]. MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions ( 5.2 )].

MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with OLUMIANT. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions ( 5.3 )].

MAJOR ADVERSE CARDIOVASCULAR EVENTS In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor,…

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE OLUMIANT ® is a Janus kinase (JAK) inhibitor indicated for: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

( 1.2 ) the treatment of adult patients with severe alopecia areata. ( 1.3 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. ( 1.3 )

1.1Rheumatoid Arthritis OLUMIANT ® (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

1.2Coronavirus Disease 2019 (COVID-19) OLUMIANT is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

1.3Alopecia Areata OLUMIANT is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administration Instructions : See the full prescribing information for recommended evaluations and immunizations prior to treatment. ( 2.1 ) Rheumatoid Arthritis and Alopecia Areata: Avoid initiation or interrupt OLUMIANT in patients with anemia (hemoglobin <8 g/dL), lymphopenia (ALC <500 cells/mm 3 ) or neutropenia (ANC <1000 cells/mm 3 ). ( 2.1 , 2.5 , 5.9 ) COVID-19: Avoid initiation or interrupt OLUMIANT in patients with lymphopenia (ALC <200 cells/mm 3 ) or neutropenia (ANC <500 cells/mm 3 ).

( 2.1 , 2.5 , 5.9 ) Recommended Dosage : Rheumatoid Arthritis: 2 mg once daily. ( 2.2 ) OLUMIANT may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. ( 2.2 ) COVID-19: 4 mg once daily for up to 14 days.

( 2.3 ) Alopecia Areata: 2 mg once daily. Increase to 4 mg once daily, if the response to treatment is not adequate. ( 2.4 ) For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg once daily.

( 2.4 ) Reduce the dose to 2 mg once daily when an adequate response has been achieved. ( 2.4 ) Dosage Modifications in Patients with Renal or Hepatic Impairment, or Cytopenias See the full prescribing information for dosage modifications by indication. ( 2.5 , 2.6 , 5.9 )

2.1Recommended Evaluations and Immunization Prior to Treatment Initiation Prior to OLUMIANT treatment initiation, consider performing the following evaluations: Active and latent tuberculosis (TB) infection evaluation – OLUMIANT should not be given to patients with active tuberculosis (TB). If latent infection is positive in patients with rheumatoid arthritis or alopecia areata, consider treatment for TB prior to OLUMIANT use [see Warnings and Precautions ( 5.1 )] . Viral hepatitis screening in accordance with clinical guidelines [see Warnings and Precautions ( 5.1 )] .

Complete blood count – Assess baseline values and verify whether treatment can be initiated: - In patients with rheumatoid arthritis or alopecia areata, OLUMIANT initiation is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/μl, absolute neutrophil count (ANC) <1000 cells/μl, or hemoglobin level <8 g/dL. - In patients with COVID-19, OLUMIANT initiation is not recommended if the ALC is <200 cells/μl or if the ANC is <500 cells/μl. Monitor complete blood counts during treatment and modify dosage as recommended [see Dosage and Administration ( 2.5 ) and Warnings and Precautions ( 5.7 )] .

Baseline hepatic and renal function – Assess baseline values and monitor patients for laboratory changes. Modify dosage based on hepatic and renal impairment, and laboratory abnormalities [see Dosage and Administration ( 2.5 ) and Warnings and Precautions ( 5.7 )] . In patients with rheumatoid arthritis or alopecia areata, update immunizations in agreement with current immunization guidelines [see Warnings and Precautions ( 5.10 )] .

2.2Dosage Recommendations in Rheumatoid Arthritis The recommended dosage of OLUMIANT is 2 mg once daily orally, with or without food [see Clinical Pharmacology ( 12.3 )] . An alternative administration for patients unable to swallow tablets may be used [see Dosage and Administration ( 2.8 )] . OLUMIANT may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.

2.3Dosage Recommendations in COVID-19 The recommended dosage of OLUMIANT for adults is 4 mg once daily orally, with or without food, for 14 days or until hospital discharge, whichever occurs first. An alternative administration for patients unable to swallow tablets may be used [see Dosage and Administration ( 2.8 )] .

2.4Dosage Recommendations in Alopecia Areata The recommended dosage of OLUMIANT is 2 mg once daily orally, with or without food. Increase to 4 mg once daily if the response to treatment is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or e…

💊 Dosage Forms and Strengths 110 words ▾

3 DOSAGE FORMS AND STRENGTHS OLUMIANT is available as debossed, film-coated tablets: 1 mg tablet contains a recessed area on each face of the tablet surface, is very light pink, round, debossed with “Lilly” on one side and “1” on the other. 2 mg tablet contains a recessed area on each face of the tablet surface, is light pink, oblong, debossed with “Lilly” on one side and “2” on the other. 4 mg tablet contains a recessed area on each face of the tablet surface, is medium pink, round, debossed with “Lilly” on one side and “4” on the other.

Tablets: 4 mg, 2 mg, 1 mg ( 3 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity : Serious reactions have been reported. Discontinue OLUMIANT if a serious hypersensitivity reaction occurs. ( 5.6 ) Gastrointestinal Perforations : Monitor patients who may be at increased risk and evaluate promptly new onset of abdominal symptoms.

( 5.7 ) Hypoglycemia in Patients with Diabetes : Consider increased monitoring of blood glucose; advise patients with diabetes to notify their healthcare provider if they develop signs or symptoms of hypoglycemia. ( 5.8 ) Laboratory Abnormalities : Monitor for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids. ( 5.9 ) Vaccinations : Avoid use with live vaccines.

( 5.10 )

5.1Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients with rheumatoid arthritis receiving OLUMIANT. The most common serious infections reported with OLUMIANT included pneumonia, herpes zoster, and urinary tract infection [see Adverse Reactions ( 6.1 )] . Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with OLUMIANT.

Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of OLUMIANT in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OLUMIANT in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an 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.

In patients with rheumatoid arthritis or alopecia areata, closely monitor for the development of signs and symptoms of infection during and after treatment with OLUMIANT. Interrupt OLUMIANT in patients with rheumatoid arthritis or alopecia areata, if the patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with OLUMIANT should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and OLUMIANT should be interrupted if the patient is not responding to therapy.

Do not resume OLUMIANT until the infection is controlled. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with OLUMIANT. There is limited information regarding the use of OLUMIANT in patients with COVID-19 and concomitant active serious infections.

The risks and benefits of treatment with OLUMIANT in COVID-19 patients with other concurrent infections should be considered. Tuberculosis Evaluate patients for active infection prior to administration of OLUMIANT. OLUMIANT should not be given to patients with active TB.

Test patients with rheumatoid arthritis or alopecia areata for latent tuberculosis. Patients with rheumatoid arthritis or alopecia areata and latent tuberculosis (TB) should be treated with standard antimycobacterial therapy before initiating OLUMIANT. Consider anti-TB therapy prior to initiation of OLUMIANT in patients with a history of latent 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. During OLUMIANT use, monitor patients for the development of signs and symptoms of TB, including patients w…

🤒 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 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Hypersensitivity [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Diabetes [see Warnings and Precautions ( 5.8 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.9 )] Adverse reactions reported in clinical trials (≥1%) are: Rheumatoid Arthritis : upper respiratory tract infections (URTIs), nausea, herpes simplex, and herpes zoster.

( 6.1 ) COVID-19: increases of liver enzymes, thrombocytosis, creatine phosphokinase increases, neutropenia, deep vein thrombosis, pulmonary embolism, and urinary tract infection (UTI) ( 6.1 ) Alopecia Areata : URTIs, headache, acne, hyperlipidemia, creatine phosphokinase increase, UTI, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. Adverse Reactions in Patients with Rheumatoid Arthritis The safety of OLUMIANT was evaluated in six randomized double-blind placebo-controlled studies (three Phase 2, three Phase 3) and a long-term extension study in patients with moderately to severely active RA.

Patients were randomized to placebo (1070 patients), OLUMIANT 2 mg (479 patients), or baricitinib 4 mg (997 patients). Patients could be switched to baricitinib 4 mg from placebo or OLUMIANT 2 mg from as early as Week 12 depending on the study design. All patients initially randomized to placebo were switched to baricitinib 4 mg by Week 24.

During the 16-week treatment period, adverse events leading to discontinuation of treatment were reported by 35 patients (11.4 per 100 patient-years) treated with placebo, 17 patients (12.1 per 100 patient-years) with OLUMIANT 2 mg, and 40 patients (13.4 per 100 patient-years) treated with baricitinib 4 mg. During 0 to 52-week exposure, adverse events leading to discontinuation of treatment were reported by 31 patients (9.2 per 100 patient-years) with OLUMIANT 2 mg, and 92 patients (10.2 per 100 patient-years) treated with baricitinib 4 mg.

Overall Infections – During the 16-week treatment period, infections were reported by 253 patients (82.1 per 100 patient-years) treated with placebo, 139 patients (99.1 per 100 patient-years) treated with OLUMIANT 2 mg, and 298 patients (100.1 per 100 patient-years) treated with baricitinib 4 mg. During 0 to 52-week exposure, infections were reported by 200 patients (59.6 per 100 patients-years) treated with OLUMIANT 2 mg, and 500 patients (55.3 per 100 patient-years) treated with baricitinib 4 mg. In the 0 to 52-week exposure population, the most commonly reported infections with OLUMIANT were viral upper respiratory tract infection, upper respiratory tract infection, urinary tract infection, and bronchitis.

Serious Infections – During the 16-week treatment period, serious infections were reported in 13 patients (4.2 per 100 patient-years) treated with placebo, 5 patients (3.6 per 100 patient-years) treated with OLUMIANT 2 mg, and 11 patients (3.7 per 100 patient-years) treated with…

🔄 Drug Interactions 106 words ▾

7 DRUG INTERACTIONS In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) the recommended dosage should be reduced. ( 2.7 , 7.1 )

7.1Strong OAT3 Inhibitors Baricitinib exposure is increased when OLUMIANT is co-administered with strong OAT3 inhibitors (such as probenecid), hence the dosage of baricitinib should be reduced by half the recommended dose [see Dosage and Administration ( 2.2 , 2.3 ) and Clinical Pharmacology ( 12.3 )] .

7.2Other JAK Inhibitors or Biologic DMARDs OLUMIANT has not been studied in combination with other JAK inhibitors or with biologic DMARDs [see Indications and Usage ( 1.1 , 1.2 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment : Not recommended in patients with RA or AA and severe hepatic impairment. OLUMIANT has not been studied in patients with COVID-19 and severe hepatic impairment. ( 2.5 , 8.6 ) Renal Impairment : Not recommended in COVID-19 patients with eGFR <15 mL/min/1.73m 2 , who are on dialysis, have ESRD, or acute kidney injury.

OLUMIANT is not recommend in patients with RA or AA with eGFR <30 mL/min/1.73m 2 . ( 2.6 , 8.7 ) Pregnancy : Based on animal data, may cause fetal harm. ( 8.1 , 8.3 ) Lactation : Advise not to breastfeed.

( 8.2 )

8.1Pregnancy Risk Summary Based on the findings from animal reproduction studies, OLUMIANT may cause fetal harm during pregnancy. Available data from clinical trials and postmarketing case reports with OLUMIANT exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no human data on chronic baricitinib exposure throughout pregnancy.

There are risks to the mother and the fetus associated with rheumatoid arthritis in pregnancy (see Clinical Considerations) . Consider the risks and benefits with chronic use of OLUMIANT during pregnancy. In animal embryo-fetal development studies, oral baricitinib administration to pregnant rats and rabbits at exposures equal to and greater than approximately 11 and 46 times the maximum recommended human dose (MRHD) of 4 mg/day, respectively, resulted in reduced fetal body weights, increased embryolethality (rabbits only), and dose-related increases in skeletal malformations.

No developmental toxicity was observed in pregnant rats and rabbits treated with oral baricitinib during organogenesis at approximately 2 and 7 times the exposure at the MRHD, respectively. In a pre- and post-natal development study in pregnant female rats, oral baricitinib administration at exposures approximately 24 times the MRHD resulted in reduction in pup viability (increased incidence of stillborn pups and early neonatal deaths), decreased fetal birth weight, reduced fetal body weight gain, decreased cytotoxic T cells on post-natal day (PND) 35 with evidence of recovery by PND 65, and developmental delays that might be attributable to decreased body weight gain.

No developmental toxicity was observed at an exposure approximately 5 times the exposure at the MRHD (see Data) . The background risks of major birth defects and miscarriage for the indicated population(s) are 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 2-4% and 15-20%, respectively. Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis.

Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Animal Data In an embryofetal development study in pregnant rats, dosed orally during the period of organogenesis from gestation days 6 to 17, baricitinib was teratogenic (skeletal malformations that consisted of bent limb bones and rib anomalies) at exposures equal to or greater than approximately 11 times the MRHD (on an AUC basis at maternal oral doses of 10 mg/kg/day and higher).

🤰 Pregnancy ~3 min read ▾

No developmental toxicity was observed in rats at an exposure approximately 2 times the MRHD (on an AUC basis at a maternal oral dose of 2 mg/kg/day). In an embryofetal development study in pregnant rabbits, dosed orally during the period of organogenesis from gestation days 7 to 20, embryolethality, decreased fetal body weights, and skeletal malformations (rib anomalies) were observed in the presence of maternal toxicity at an exposure approximately 46 times the MRHD (on an AUC basis at a maternal oral dose of 30 mg/kg/day).

Embryolethality consisted of increased post-implantation loss that was due to elevated incidences of both early and late resorptions. No developmental toxicity was observed in rabbits at an exposure approximately 7 times the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day). In a pre- and post-natal development study in pregnant female rats dosed orally from gestation day 6 through lactat…

🧒 Pediatric Use 16 words ▾

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

🧓 Geriatric Use 219 words ▾

8.5Geriatric Use Of the 3100 patients treated in the rheumatoid arthritis clinical trials, a total of 537 patients were 65 years of age and older, including 71 patients 75 years of age and older. Of the 2558 patients treated in the COVID-19 clinical trials, a total of 791 were 65 years of age and older, including 295 patients 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, 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 [see Clinical Pharmacology ( 12.3 )] .

Of the 1200 patients in the alopecia areata clinical trials, a total of 29 patients were 65 years of age or older. The number of patients aged 65 years and older was not sufficient to determine whether they respond differently from younger patients. OLUMIANT is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because geriatric patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration ( 2.6 )] .

🆘 Overdosage 88 words ▾

10 OVERDOSAGE Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity. Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 24 hours. In case of an overdose, it is recommended that the patient should be monitored for signs and symptoms of adverse reactions.

Patients who develop adverse reactions should receive appropriate treatment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression.

Baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. JAK enzymes transmit cytokine signaling through their pairing (e.g., JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, JAK2/JAK2, JAK2/TYK2). In cell-free isolated enzyme assays, baricitinib had greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3.

In human leukocytes, baricitinib inhibited cytokine induced STAT phosphorylation mediated by JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, or JAK2/TYK2 with comparable potencies. However, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

12.2Pharmacodynamics Baricitinib inhibition of IL-6 induced STAT3 phosphorylation – Baricitinib administration resulted in a dose dependent inhibition of IL-6 induced STAT3 phosphorylation in whole blood from healthy subjects with maximal inhibition observed approximately 1 hour after dosing, which returned to near baseline by 24 hours. Similar levels of inhibition were observed using either IL-6 or TPO as the stimulus. Immunoglobulins – Mean serum IgG, IgM, and IgA values decreased by 12 weeks after starting treatment with OLUMIANT, and remained stable through at least 52 weeks.

For most patients, changes in immunoglobulins occurred within the normal reference range. C-reactive protein – In patients with rheumatoid arthritis, decreases in serum C-reactive protein (CRP) were observed as early as one week after starting treatment with OLUMIANT and were maintained throughout dosing. Cardiac Electrophysiology – At a dose 10 times the maximum recommended dose, baricitinib does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Following oral administration of OLUMIANT, peak plasma concentrations are reached approximately at 1 hour. A dose-proportional increase in systemic exposure was observed in the therapeutic dose range. The pharmacokinetics of baricitinib do not change over time.

Steady-state concentrations are achieved in 2 to 3 days with minimal accumulation after once-daily administration. Absorption – The absolute bioavailability of baricitinib is approximately 80%. An assessment of food effects in healthy subjects showed that a high-fat meal decreased the mean AUC and C max of baricitinib by approximately 11% and 18%, respectively, and delayed the t max by 0.5 hours.

Administration with meals is not associated with a clinically relevant effect on exposure. In clinical studies, OLUMIANT was administered without regard to meals. Distribution – After intravenous administration, the volume of distribution is 76 L, indicating distribution of baricitinib into tissues.

Baricitinib is approximately 50% bound to plasma proteins and 45% bound to serum proteins. Baricitinib is a substrate of the Pgp, BCRP, OAT3 and MATE2-K transporters, which play roles in drug distribution. Elimination Rheumatoid Arthritis and Alopecia Areata : The total body clearance of baricitinib is

8.9L/h in patients with rheumatoid arthritis and 11 L/h in patients with alopecia areata. Elimination half-life in patients with rheumatoid arthritis and alopecia areata is approximately 12 to 16 hours. COVID-19: The total body clearance and half-life of baricitinib is

14.2L/h and 10.8 hours, respectively, in patients with COVID-19 who are intubated and have baricitinib administered via NG or OG tube. Metabolism – Approximately 6% of the orally administered baricitinib dose is identified as metabolites (th…

🧬 Mechanism of Action 145 words ▾

📦 How Supplied / Storage and Handling 160 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied OLUMIANT for oral administration is available as debossed, film-coated, tablets. Each tablet contains a recessed area on each face of the tablet surface. OLUMIANT Tablets 1 mg 2 mg 4 mg Color Very Light Pink Light Pink Medium Pink Shape Round Oblong Round Identification Lilly Lilly Lilly 1 2 4 NDC Codes Bottle of 30 0002-4732-30 0002-4182-30 0002-4479-30

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Keep out of reach of children.

📦 Storage and Handling 33 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Keep out of reach of children.

📋 Description 165 words ▾

11 DESCRIPTION OLUMIANT (baricitinib) is a Janus kinase (JAK) inhibitor with the chemical name {1-(ethylsulfonyl)-3-[4-(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)-1 H -pyrazol-1-yl]azetidin-3-yl}acetonitrile. Baricitinib has an empirical formula of C 16 H 17 N 7 O 2 S and a molecular weight of 371.42. Baricitinib has the following structural formula: OLUMIANT tablets contain a recessed area on each face of the tablet surface and are available for oral administration as debossed, film-coated tablets.

The 1 mg tablet is very light pink, round, debossed with “Lilly” on one side and “1” on the other. The 2 mg tablet is light pink, oblong, debossed with “Lilly” on one side and “2” on the other. The 4 mg tablet is medium pink, round, debossed with “Lilly” on one side and “4” on the other.

Each tablet contains 1, 2, or 4 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, ferric oxide, lecithin (soya), magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling ( Medication Guide ). Infections Inform patients that they may be more likely to develop infections when taking OLUMIANT. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions ( 5.1 )] .

Advise patients that the risk of herpes zoster is increased in patients treated with OLUMIANT and some cases can be serious [see Warnings and Precautions ( 5.1 )] . Malignancies and Lymphoproliferative Disorders Inform patients that OLUMIANT may increase their risk of developing lymphomas and other malignancies, including of the skin and that periodic skin examinations should be performed while using OLUMIANT. 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 OLUMIANT may increase their 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 and PE have been reported in clinical studies with OLUMIANT.

Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions ( 5.5 )] . Hypersensitivity Reactions Advise patients to discontinue OLUMIANT and seek immediate medical attention if they develop any signs and symptoms of serious allergic reactions [see Warnings and Precautions ( 5.6 )] . Gastrointestinal Perforations Inform patients that gastrointestinal perforations have been reported in clinical trials with OLUMIANT.

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 OLUMIANT. Advise patients with diabetes to notify their healthcare provider if they develop signs or symptoms of hypoglycemia [see Warnings and Precautions ( 5.8 )] .

Laboratory Abnormalities Inform patients that OLUMIANT may affect certain lab tests, and that blood tests are required before and during OLUMIANT treatment [see Warnings and Precautions ( 5.9 )] . Live Vaccines Instruct patients to inform the healthcare practitioner that they are taking OLUMIANT prior to a potential vaccination since the use of live vaccine is not recommended [see Warnings and Precautions ( 5.10 )] . Pregnancy Advise pregnant females and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with OLUMIANT.

Inform patients to report their pregnancy to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) [see Use in Specific Populations ( 8.1 , 8.3 )] . Lactation Advise a woman not to breastfeed during treatment with OLUMIANT and for four days after the last dose [see Use in Specific Populations ( 8.2 )] . Literature revised: 06/2026 Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA www.olumiant.com Copyright © 2018, 2026, Eli Lilly and Company.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2026 MEDICATION GUIDE OLUMIANT ® (O-loo-me-ant) (baricitinib) tablets, for oral use What is the most important information I should know about OLUMIANT?

OLUMIANT may cause serious side effects, including : 1. Serious infections. OLUMIANT is a medicine that affects your immune system.

OLUMIANT can lower the ability of your immune system to fight infections. Some people have had serious infections while taking OLUMIANT, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

Your healthcare provider should test you for TB before starting treatment with OLUMIANT for rheumatoid arthritis or alopecia areata. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OLUMIANT. You should not start taking OLUMIANT 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. Before starting OLUMIANT, 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 C live or have lived, or have traveled to certain parts of the country (such as the 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 OLUMIANT. 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 feeling tired muscle aches blood in your phlegm diarrhea or stomach pain cough weight loss burning when you urinate or urinating more often than normal After starting OLUMIANT, call your healthcare provider right away if you have any symptoms of an infection.

OLUMIANT can make you more likely to get infections or, make worse any infection that you have. If you get a serious infection, your healthcare provider may stop your treatment with OLUMIANT 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. OLUMIANT is a JAK inhibitor medicine. 3.

Cancer and immune system problems. OLUMIANT 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 OLUMIANT.

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. Tell your healthcare provider if you have ever had any type of cancer. Follow your healthcare provider's advice about having your skin checked for skin cancer during treatment with OLUMIANT.

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 have any symptoms of a heart attack or stroke while taking OLUMIANT, 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…

Glossary — plain-language definitions of medical terms used in this label:

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

absolute neutrophil count: A blood test number showing how many infection-fighting neutrophil white blood cells you have.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alopecia: Loss of hair from the scalp or body.

ANC: A blood test number showing how many infection-fighting neutrophil white blood cells you have.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

BCRP: A protein pump that moves certain drugs out of cells, affecting how much of the drug is absorbed.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

complete blood count: A common blood test that measures red blood cells, white blood cells, and platelets.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cytotoxic: Describing a substance that kills cells, especially fast-growing ones such as cancer cells.

deep vein thrombosis: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose-limiting toxicity: A side effect severe enough that it prevents giving a higher dose of a medicine.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

DVT: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

herpes zoster: The medical name for shingles, a painful rash caused by reactivation of the virus that causes chickenpox.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

immunocompromised: Having a weakened immune system, so the body is less able to fight off infections.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

latent infection: An infection that stays inactive and hidden in the body, causing no symptoms but able to wake up and cause illness later.

lymphopenia: A low level of lymphocytes, a type of white blood cell that is important for immune defense.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

neutrophil: A type of white blood cell that is one of the body's main defenders against infection.

opportunistic infection: An infection caused by germs that usually don't make healthy people sick, but can take hold when the body's defenses are weak.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pulmonary embolism: A blood clot that has traveled to the lungs and blocks blood flow there, which can make breathing hard.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

TB: A serious infection, usually of the lungs, caused by tuberculosis bacteria and spread through the air.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombocytosis: A higher-than-normal level of platelets, the blood cells that help form clots.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

transporter: A protein that moves drugs across cell membranes, carrying them either into or out of cells.

tuberculosis: A serious infection, usually of the lungs, caused by tuberculosis bacteria and spread through the air.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 00002-4612-11 · Eli 00002-4794-31 · Eli →

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.

Olumiant baricitinib 1 mg Tablet, Film Coated, 30-count

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