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Yuflyma adalimumab-aaty Kit — NDC 72606-0063-01 package photo

Yuflyma adalimumab-aaty Kit

by CELLTRION USA, Inc. · 2 KIT in 1 CARTON (72606-063-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET
NDC 72606-0063-01
🏷️ FDA NDC (as labeled) 72606-063-01 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 16, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Oct 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 72606-063-01
Product NDC 72606-063
11-digit billing NDC 72606006301
Application # BLA761219
SPL Set ID 526d626f-8c9f-496c-b838-00a73bb36383
DEA schedule Non-controlled
Marketing category BLA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Oct 2025)
Marketing start 2025-10-31
Dosage form KIT
Biologic (Purple Book) 351(k) Interchangeable · interchangeable biosimilar
Reference product adalimumab
Why two NDCs? The FDA registers this code as 72606-063-01 — 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 → 72606-0063-01. 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.

🏭 Manufacturer & labeler

LabelerCELLTRION USA, Inc.
FDA applicationBLA761219 (BLA)
Labeler code72606
First marketedOct 2025
Product typeHuman Prescription Drug
Portfolio30 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

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.

🧪 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adalimumab 72606-0041-01 CELLTRION 2 syringes — — FDA listed —
Yuflyma 72606-0039-01 CELLTRION 2 kits — — Discontinued —
Adalimumab 72606-0040-01 CELLTRION 1 syringe — — FDA listed —
Yuflyma 72606-0023-01 CELLTRION 1 syringe — — Discontinued —
Yuflyma 72606-0046-01 CELLTRION 3 kits — — Discontinued —
Yuflymathis 72606-0063-01 CELLTRION 2 kits — — Discontinued —
Adalimumab 72606-0022-01 CELLTRION 1 syringe — — FDA listed —
Yuflyma 72606-0024-01 CELLTRION 2 syringes — — Discontinued —
Yuflyma 72606-0030-01 CELLTRION 1 syringe — — Discontinued —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2023
First FDA approval
May 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
2026
Biosimilars listed
10 FDA-licensed
🧬FDA-licensed biosimilars listed

2 biosimilars and 8 interchangeables are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to May 2035.
📅 FDA approved May 23, 2023

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Humiraadalimumab
Interchangeable 8
Abriladaadalimumab-afzb Amjevitaadalimumab-atto Cyltezoadalimumab-adbm Hadlimaadalimumab-bwwd Hulioadalimumab-fkjp Hyrimozadalimumab-adaz Simlandiadalimumab-ryvk Yuflymaadalimumab-aaty
Biosimilars 2
Idacioadalimumab-aacf Yusimryadalimumab-aqvh
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMay 23, 2035
Common questions
Is there a biosimilar for this drug?
Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, 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 Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Yuflyma(Cf) Autoinjector (matched by generic name) — 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 Yuflyma(Cf) Autoinjector. CMS lists 6 products for this generic; we show the highest-spend one. 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
$12.65M
Claims incl. refills
6K
Beneficiaries
3.2K
Spend / beneficiary
$3,977.29
Spend / claim
$2,092.93
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 Yuflyma (this brand).

Top reported reactions

Intentional Dose Omission701
Death268
Device Malfunction196
Exposure Via Skin Contact163
Arthralgia151
Condition Aggravated146
Therapy Interrupted145

Age at onset

Adult31
Elderly10

Reporter sex

0 reports
Male · 29%
Female · 71%

Serious outcomes

Death295
Disabling102
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1,368 605
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72606-0063-01 You're viewing this 2 KIT in 1 CARTON (72606-063-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2025-10-31 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package No longer marketed (per FDA listing data)

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 72606-063-01, 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: 72606-0063-01, written without dashes as 72606006301. 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 72606-0063-01, the first segment (72606) is the labeler code FDA assigned to CELLTRION USA, Inc.; the middle segment (0063) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
CELLTRION USA, 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue YUFLYMA if a patient develops a serious infection or sepsis during treatment.

Perform test for latent TB; if positive, start treatment for TB prior to starting YUFLYMA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.

Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. SERIOUS INFECTIONS Patients treated with adalimumab products, including YUFLYMA, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue YUFLYMA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease.

Test patients for latent TB before YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.

Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with YUFLYMA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )].

MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions ( 5.2 )]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal.

The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 )].

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE YUFLYMA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active p soriatic arthritis .

( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adult patients.

( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 )

1.1Rheumatoid Arthritis YUFLYMA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. YUFLYMA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

1.2Juvenile Idiopathic Arthritis YUFLYMA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUFLYMA can be used alone or in combination with methotrexate.

1.3Psoriatic Arthritis YUFLYMA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUFLYMA can be used alone or in combination with non-biologic DMARDs.

1.4Ankylosing Spondylitis YUFLYMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

1.5Crohn's Disease YUFLYMA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.

1.6Ulcerative Colitis YUFLYMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 )] .

1.7Plaque Psoriasis YUFLYMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. YUFLYMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 )] .

1.8Hidradenitis Suppurativa YUFLYMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

1.9Uveitis YUFLYMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.2 ): Adults: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis or Pediatric Uveitis ( 2.3 ): Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn's Disease ( 2.4 ): Adults : 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.

Pediatric Patients 6 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis ( 2.5 ): Adults : 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57).

Plaque Psoriasis or Adult Uveitis ( 2.6 ): Adults: 80 mg initial dose followed by 40 mg every other week starting one week after initial dose. Hidradenitis Suppurativa ( 2.7 ): Adults: Day 1: 160 mg (given in one day or split over two consecutive days) Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week Adolescents 12 years of age and older: Adolescent Weight Recommended Dosage 30 kg (66 lbs) to less than 60 kg (132 lbs) Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week 60 kg (132 lbs) and greater Day 1: 160 mg (given in one day or split over two consecutive days) Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

2.1Recommended Tuberculosis Evaluation Prior to initiating YUFLYMA and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions ( 5.1 )] .

2.2Recommended Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis The recommended subcutaneous dosage of YUFLYMA for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) [see Indications and Usage ( 1.1 , 1.3 , 1.4 )] is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with YUFLYMA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of YUFLYMA to 40 mg every week or 80 mg every other week.

2.3Recommended Dosage in Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis The recommended subcutaneous dosage of YUFLYMA for pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) or pediatric uveitis [see Indications and Usage ( 1.2 , 1.9 )] , based on weight, is shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with YUFLYMA. Pediatric Weight (2 years of age and older) Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Adalimumab products have not been studied in patients with polyarticular JIA or pediatric uveitis less than 2 years of age or in patients with a weight below 10 kg.

2.4Recommended Dosage in Crohn's Disease Subcutaneous Adult Dosage Regimen The recommended subcutaneous dosage of YUFLYMA for adult patients with moderately to…

💊 Dosage Forms and Strengths 154 words ▾

3 DOSAGE FORMS AND STRENGTHS YUFLYMA is a clear to opalescent, and colorless to pale brown solution available as: Auto-injector (YUFLYMA AI) Injection: 80 mg/0.8 mL in a single-dose auto-injector. Injection: 40 mg/0.4 mL in a single-dose auto-injector. Prefilled Syringe with Safety Guard Injection: 80 mg/0.8 mL in a single-dose prefilled syringe with safety guard.

Injection: 40 mg/0.4 mL in a single-dose prefilled syringe with safety guard. Prefilled Syringe Injection: 80 mg/0.8 mL in a single-dose prefilled syringe. Injection: 40 mg/0.4 mL in a single-dose prefilled syringe.

Injection: 20 mg/0.2 mL in a single-dose prefilled syringe. Injection: 10 mg/0.1 mL in a single-dose prefilled syringe. Injection: Single-dose prefilled auto-injector (YUFLYMA AI): 80 mg/0.8 mL, 40 mg/0.4 mL ( 3 ) Single-dose prefilled syringe with safety guard : 80 mg/0.8 mL, 40 mg/0.4 mL ( 3 ) Single-dose prefilled syringe: 80 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.1 mL ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious infections: Do not start YUFLYMA during an active infection. If an infection develops, monitor carefully, and stop YUFLYMA if infection becomes serious ( 5.1 ) Invasive fungal infections: For patients who develop a systemic illness on YUFLYMA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic ( 5.1 ) Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls ( 5.2 ) Anaphylaxis or serious hypersensitivity reactions may occur ( 5.3 ) Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy.

If reactivation occurs, stop YUFLYMA and begin anti-viral therapy ( 5.4 ) Demyelinating disease: Exacerbation or new onset, may occur ( 5.5 ) Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping YUFLYMA ( 5.6 ) Heart failure: Worsening or new onset, may occur ( 5.8 ) Autoimmunity: Stop YUFLYMA if lupus-like syndrome or autoimmune hepatitis develop ( 5.9 )

5.1Serious Infections Patients treated with adalimumab products, including YUFLYMA, are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers.

Patients have frequently presented with disseminated rather than localized disease. The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections in patients with rheumatoid arthritis (RA); therefore, the concomitant use of YUFLYMA and these biologic products is not recommended in the treatment of patients with RA [see Warnings and Precautions ( 5.7 , 5.11 ) and Drug Interactions ( 7.2 )] . Treatment with YUFLYMA should not be initiated in patients with an active infection, including localized infections.

Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection.

Tuberculosis Cases of reactivation of tuberculosis and new onset tuberculosis infections have been reported in patients receiving adalimumab products, including patients who have previously received treatment for latent or active tuberculosis. Reports included cases of pulmonary and extrapulmonary (i.e., disseminated) tuberculosis. Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating YUFLYMA and periodically during therapy.

Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Prior to initiating YUFLYMA, assess if treatment for latent tuberculosis is needed; and consider an induration of ≥ 5 mm a positive tuberculin skin test result, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG). Consider anti-tuberculosis therapy prior to initiation of YUFLYMA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.…

🤒 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 )] Malignancies [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Hepatitis B Virus Reactivation [see Warnings and Precautions ( 5.4 )] Neurologic Reactions [see Warnings and Precautions ( 5.5 )] Hematological Reactions [see Warnings and Precautions ( 5.6 )] Heart Failure [see Warnings and Precautions ( 5.8 )] Autoimmunity [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (> 10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA Inc., at 1-800-560-9414 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 most common adverse reaction with adalimumab was injection site reactions. In placebo-controlled trials, 20% of subjects treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of subjects receiving placebo.

Most injection site reactions were described as mild and generally did not necessitate drug discontinuation. The proportion of subjects who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in subjects with RA (i.e., Studies RA-I, RA-II, RA-III and RA-IV) was 7% for subjects taking adalimumab and 4% for placebo-treated subjects. The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).

Infections In the controlled portions of the 39 global adalimumab clinical trials in adult subjects with RA, PsA, AS, CD, UC, Ps, HS and UV, the rate of serious infections was 4.3 per 100 patient-years in 7973 adalimumab-treated subjects versus a rate of 2.9 per 100 patient-years in 4848 control-treated subjects. Serious infections observed included pneumonia, septic arthritis, prosthetic and post-surgical infections, erysipelas, cellulitis, diverticulitis, and pyelonephritis [see Warnings and Precautions ( 5.1 )]. Tuberculosis and Opportunistic Infections In 52 global controlled and uncontrolled clinical trials in RA, PsA, AS, CD, UC, Ps, HS and UV that included 24,605 adalimumab-treated subjects, the rate of reported active tuberculosis was 0.20 per 100 patient-years and the rate of positive PPD conversion was 0.09 per 100 patient-years.

In a subgroup of 10,113 U.S. and Canadian adalimumab-treated subjects, the rate of reported active TB was 0.05 per 100 patient-years and the rate of positive PPD conversion was 0.07 per 100 patient-years. These trials included reports of miliary, lymphatic, peritoneal, and pulmonary TB. Most of the TB cases occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease.

In these global clinical trials, cases of serious opportunistic infections have been reported at an overall rate of 0.05 per 100 patient-years. Some cases of serious opportunistic infections and TB have been fatal [see Warnings and Precautions ( 5.1 )]. Autoantibodies In the rheumatoid arthritis-controlled trials, 12% of subjects treated with adalimumab and 7% of placebo-treated subjects that had negative baseline ANA titers developed positive titers at week 24.

Two subjects out of 3046 treated with adalimumab developed clinical signs suggestive of new-onset lupus-like syndrome. The subjects improved following discontinuation of therapy. No subjects developed lupus nephritis or central nervous system symp…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Abatacept: Increased risk of serious infection ( 5.1 , 5.11 , 7.2 ) Anakinra: Increased risk of serious infection ( 5.1 , 5.7 , 7.2 ) Live vaccines: Avoid use with YUFLYMA ( 5.10 , 7.3 )

7.1Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent clearance of adalimumab, the data do not suggest the need for dose adjustment of either YUFLYMA or MTX [see Clinical Pharmacology ( 12.3 )] .

7.2Biological Products In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of YUFLYMA with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions ( 5.7 , 5.11 )] . A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, Ps, HS and UV.

Concomitant administration of YUFLYMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions.

7.3Live Vaccines Avoid the use of live vaccines with YUFLYMA [see Warnings and Precautions ( 5.10 )].

7.4Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFα, IL-6) during chronic inflammation. It is possible for products that antagonize cytokine activity, such as adalimumab products, to influence the formation of CYP450 enzymes. Upon initiation or discontinuation of YUFLYMA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab. Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease-matched comparison cohort.

The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see Data ) . Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see Clinical Considerations ) . In an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD) of 40 mg subcutaneous without methotrexate (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with RA or inflammatory bowel disease (IBD) is associated with increased disease activity. 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. Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see Data ] .

Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see Use in Specific Populations ( 8.4 )] . Data Human Data A prospective cohort pregnancy exposure registry conducted by OTIS/MotherToBaby in the U.S. and Canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 RA, 152 CD) treated with adalimumab during the first trimester and 106 women (74 RA, 32 CD) not treated with adalimumab.

The proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% RA, 10.5% CD) and 7.5% (6.8% RA, 9.4% CD), respectively. The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. This study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design.

In an independent clinical study conducted in ten pregnant women with IBD treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. The last dose of adalimumab was given between 1 and 56 days prior to delivery. Adalimumab concentrations were 0.16-19.7 mcg/mL in cord blood, 4.28-17.7 mcg/mL in infant serum, and 0-16.1 mcg/mL in maternal serum.

In all but one case, the cord blood concentration of adalimumab was hig…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab. Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease-matched comparison cohort.

The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see Data ) . Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see Clinical Considerations ) . In an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD) of 40 mg subcutaneous without methotrexate (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with RA or inflammatory bowel disease (IBD) is associated with increased disease activity. 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. Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see Data ] .

Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see Use in Specific Populations ( 8.4 )] . Data Human Data A prospective cohort pregnancy exposure registry conducted by OTIS/MotherToBaby in the U.S. and Canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 RA, 152 CD) treated with adalimumab during the first trimester and 106 women (74 RA, 32 CD) not treated with adalimumab.

The proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% RA, 10.5% CD) and 7.5% (6.8% RA, 9.4% CD), respectively. The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. This study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design.

In an independent clinical study conducted in ten pregnant women with IBD treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. The last dose of adalimumab was given between 1 and 56 days prior to delivery. Adalimumab concentrations were 0.16-19.7 mcg/mL in cord blood, 4.28-17.7 mcg/mL in infant serum, and 0-16.1 mcg/mL in maternal serum.

In all but one case, the cord blood concentration of adalimumab was higher than the maternal serum co…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of YUFLYMA have not been established in pediatric patients with psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis. The safety and effectiveness of YUFLYMA have been established for: reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older. the treatment of moderately to severely active Crohn's disease in pediatric patients 6 years of age and older. the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older.

A pediatric assessment for YUFLYMA demonstrates that YUFLYMA is safe and effective for pediatric patients in an indication for which Humira (adalimumab) is approved. However, YUFLYMA is not approved for such indication due to marketing exclusivity for Humira (adalimumab). Due to their inhibition of TNFα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant.

Data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see Use in Specific Populations ( 8.1 )] . The clinical significance of elevated adalimumab concentrations in infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown.

Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. Post-marketing cases of lymphoma, including hepatosplenic T-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blockers including adalimumab products [see Warnings and Precautions ( 5.2 )] . Juvenile Idiopathic Arthritis The safety and effectiveness of YUFLYMA for the treatment of moderately to severely active polyarticular JIA have been established in pediatric patients 2 years of age and older.

Use for this indication is supported by evidence from an adequate and well-controlled study (Study JIA) of adalimumab in patients 4 to 17 years of age [see Clinical Studies ( 14.2 )] and a safety study (Study JIA-II) of adalimumab in patients 2 to < 4 years of age where the safety profile was similar to patients 4 to 17 years of age [see Adverse Reactions ( 6.1 )] . Adalimumab products have not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg. The safety of adalimumab in pediatric patients in the polyarticular JIA trials was generally similar to that observed in adults with certain exceptions [see Adverse Reactions ( 6.1 )] .

The safety and effectiveness of YUFLYMA have not been established in pediatric patients with JIA less than 2 years of age. Pediatric Crohn's Disease The safety and effectiveness of YUFLYMA for the treatment of moderately to severely active Crohn's disease have been established in pediatric patients 6 years of age and older. Use of YUFLYMA for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.2 , 12.3 ), Clinical Studies ( 14.6 )] .

The adverse reaction profile in patients 6 years to 17 years of age was similar to adults. The safety and effectiveness of YUFLYMA have not been established in pediatric patients with Crohn's disease less than 6 years of age. Pediatric Uveitis The safety and effectiveness of YUFLYMA for the treatment of non-infectious, intermediate, posterior, and panuveitis have been established in pediatric patients 2 years of age and older.

Use of YUFLYMA for this indication is supported by evidence from adequate and well-controlled studies of adal…

🧓 Geriatric Use 119 words ▾

8.5Geriatric Use In clinical studies of RA (Studies RA-I, RA-II, RA-III, and RA-IV), a total of 519 subjects 65 years of age and older, including 107 subjects 75 years of age and older, received adalimumab. No overall difference in effectiveness was observed between these subjects and younger adult subjects. The frequency of serious infection and malignancy among adalimumab treated subjects 65 years of age and older was higher than for those less than 65 years of age.

Consider the benefits and risks of YUFLYMA in patients 65 years of age and older. In patients treated with YUFLYMA, closely monitor for the development of infection or malignancy [ see Warnings and Precautions ( 5.1 , 5.2 ) ] .

🆘 Overdosage 63 words ▾

10 OVERDOSAGE Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Consider contacting the Poison Help line (1-800-222-1222) or medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta).

TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased concentrations of TNF are also found in psoriasis plaques.

In Ps, treatment with YUFLYMA may reduce the epidermal thickness and infiltration of inflammatory cells. The relationship between these pharmacodynamic activities and the mechanism(s) by which adalimumab products exert their clinical effects is unknown. Adalimumab products also modulate biological responses that are induced or regulated by TNF, including changes in the concentrations of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC 50 of 1-2 × 10 -10 M).

12.2Pharmacodynamics After treatment with adalimumab, a decrease in concentrations of acute phase reactants of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis. A decrease in CRP concentrations was also observed in patients with Crohn's disease, ulcerative colitis and hidradenitis suppurativa. Serum concentrations of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodeling responsible for cartilage destruction were also decreased after adalimumab administration.

12.3Pharmacokinetics The pharmacokinetics of adalimumab were linear over the dose range of 0.5 to 10 mg/kg following administration of a single intravenous dose (adalimumab products are not approved for intravenous use). Following 20, 40, and 80 mg every other week and every week subcutaneous administration, adalimumab mean serum trough concentrations at steady state increased approximately proportionally with dose in RA patients. The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies.

Healthy subjects and patients with RA displayed similar adalimumab pharmacokinetics. Adalimumab exposure in patients treated with 80 mg every other week is estimated to be comparable with that in patients treated with 40 mg every week. Absorption The average absolute bioavailability of adalimumab following a single 40 mg subcutaneous dose was 64%.

The mean time to reach the maximum concentration was 5.5 days (131 ± 56 hours) and the maximum serum concentration was 4.7 ± 1.6 mcg/mL in healthy subjects following a single 40 mg subcutaneous administration of adalimumab. Distribution The distribution volume (V ss ) ranged from 4.7 to

6.0L following intravenous administration of doses ranging from 0.25 to 10 mg/kg in RA patients. Elimination The single dose pharmacokinetics of adalimumab in RA patients were determined in several studies with intravenous doses ranging from 0.25 to 10 mg/kg. The systemic clearance of adalimumab is approximately 12 mL/hr.

In long-term studies with dosing more than two years, there was no evidence of changes in clearance over time in RA patients. Patient Population Rheumatoid Arthritis and Ankylosing Spondylitis: In patients receiving 40 mg adalimumab every other week, adalimumab mean steady-state trough concentrations were approximately 5 mcg/mL and 8 to 9 mcg/mL, without and with MTX concomitant treatment, respectively. Adalimumab concentrations in the synovial fluid from five rheumatoid arthritis patients ranged from 31 to 96% of those in serum.

The pharmacokinetics of adalimumab in patients with AS were similar to those in patients with RA. Pso…

🧬 Mechanism of Action 183 words ▾

12.1Mechanism of Action Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta).

TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased concentrations of TNF are also found in psoriasis plaques.

In Ps, treatment with YUFLYMA may reduce the epidermal thickness and infiltration of inflammatory cells. The relationship between these pharmacodynamic activities and the mechanism(s) by which adalimumab products exert their clinical effects is unknown. Adalimumab products also modulate biological responses that are induced or regulated by TNF, including changes in the concentrations of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC 50 of 1-2 × 10 -10 M).

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING YUFLYMA (adalimumab-aaty) is supplied as a preservative-free, sterile, clear to opalescent, and colorless to pale brown solution for subcutaneous administration. The following packaging configurations are available. YUFLYMA AI Carton - 40 mg/0.4 mL (1 Count) YUFLYMA is supplied in a carton containing two alcohol preps and one dose tray.

The dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-09. YUFLYMA AI Carton - 40 mg/0.4 mL (2 Count) YUFLYMA is supplied in a carton containing two alcohol preps and two dose trays.

Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-10. YUFLYMA AI Carton - 40 mg/0.4 mL (4 Count) YUFLYMA is supplied in a carton containing four alcohol preps and four dose trays.

Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-11. YUFLYMA AI Carton - 40 mg/0.4 mL (6 Count) YUFLYMA is supplied in a carton containing six alcohol preps and six dose trays.

Each dose tray consists of a single-dose prefilled auto-injector, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-12. Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (1 Count) YUFLYMA is supplied in a carton containing two alcohol preps and one dose tray.

The dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-05. Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (2 Count) YUFLYMA is supplied in a carton containing two alcohol preps and two dose trays.

Each dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-06. Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (4 Count) YUFLYMA is supplied in a carton containing four alcohol preps and four dose trays.

Each dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-07. Prefilled Syringe with Safety Guard Carton - 40 mg/0.4 mL (6 Count) YUFLYMA is supplied in a carton containing six alcohol preps and six dose trays.

Each dose tray consists of a single-dose prefilled syringe with safety guard, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-08. Prefilled Syringe Carton - 40 mg/0.4 mL (1 Count) YUFLYMA is supplied in a carton containing two alcohol preps and one dose tray.

The dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-01. Prefilled Syringe Carton - 40 mg/0.4 mL (2 Count) YUFLYMA is supplied in a carton containing two alcohol preps and two dose trays.

Each dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.4 mL of YUFLYMA. The NDC number is 72606-030-02. Prefilled Syringe Carton - 40 mg/0.4 mL (4 Count) YUFLYMA is supplied in a carton containing four alcohol preps and four dose trays.

Each dose tray consists of a single-dose prefilled syringe, containing a 1 mL prefilled syringe with a fixed thin wall, ½ inch needle, providing 4…

📦 Storage and Handling 126 words ▾

Storage and Stability Do not use beyond the expiration date on the container. YUFLYMA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE.

Do not use if frozen even if it has been thawed. Store in original carton until time of administration to protect from light. Do not shake.

If needed, for example when traveling, YUFLYMA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 31 days, with protection from light. YUFLYMA should be discarded if not used within the 31-day period. Record the date when YUFLYMA is first removed from the refrigerator in the spaces provided on the carton and dose pack.

Do not store YUFLYMA in extreme heat or cold.

📋 Description ~2 min read ▾

11 DESCRIPTION Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps.

It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. YUFLYMA (adalimumab-aaty) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (YUFLYMA AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe.

Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of YUFLYMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product.

Each 0.8 mL of YUFLYMA contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of YUFLYMA contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP.

Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of YUFLYMA contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product.

Each 0.1 mL of YUFLYMA contains adalimumab-aaty (10 mg), acetic acid (0.02 mg), glycine (1.88 mg), polysorbate 80 (0.1 mg), sodium acetate (0.06 mg) and Water for Injection, USP.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that YUFLYMA may lower the ability of their immune system to fight infections. Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 )] .

Malignancies Counsel patients about the risk of malignancies while receiving YUFLYMA [see Warnings and Precautions ( 5.2 )]. Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions. [see Warnings and Precautions ( 5.3 )] . Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, neurological disease, autoimmune disorders, or cytopenias.

Advise patients to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever [see Warnings and Precautions ( 5.5 , 5.6 , 5.8 , 5.9 )] . Instructions on Injection Technique Inform patients that the first injection is to be performed under the supervision of a qualified health care professional. If a patient or caregiver is to administer YUFLYMA, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of YUFLYMA [see Instructions for Use].

For patients who will use the YUFLYMA AI, tell them that they: May hear a 1 st loud "click" when they place the auto-injector straight on their skin and push the entire device down firmly. The click means the start of the injection. Must keep holding the YUFLYMA AI against their skin until all of the medicine is injected.

Will know that the injection has finished when the blue plunger rod fills the medication window and stops moving. Also they may hear a 2 nd loud "click" several seconds after starting the injection. Then, count slowly to 5 to ensure full dose has been given.

Instruct patients to dispose of their used needles and syringes or used auto-injector in a FDA-cleared sharps disposal container immediately after use. Instruct patients not to dispose of loose needles and syringes or auto-injector in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.

Instruct patients that when their sharps disposal container is almost full, they will need to follow their community guidelines for the correct way to dispose of their sharps disposal container. Instruct patients that there may be state or local laws regarding disposal of used needles and syringes. Refer patients to the FDA's website at http://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal, and for specific information about sharps disposal in the state that they live in.

Instruct patients not to dispose of their used sharps disposal container in their household trash unless their community guidelines permit this. Instruct patients not to recycle their used sharps disposal container.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE YUFLYMA ® (yoo-fly'-mah) (adalimumab-aaty) injection, for subcutaneous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2025 Read the Medication Guide that comes with YUFLYMA before you start taking it and each time you get a refill.

There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about YUFLYMA?

YUFLYMA is a medicine that affects your immune system. YUFLYMA can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products.

These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting YUFLYMA.

Your doctor should check you closely for signs and symptoms of TB during treatment with YUFLYMA. You should not start taking YUFLYMA if you have any kind of infection unless your doctor says it is okay. Before starting YUFLYMA, tell your doctor if you: think you have an infection or have symptoms of infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired weight loss are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes. have TB, or have been in close contact with someone with TB. were born in, lived in, or traveled to countries where there is more risk for getting TB.

Ask your doctor if you are not sure. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use YUFLYMA. Ask your doctor if you do not know if you have lived in an area where these infections are common. have or have had hepatitis B. use the medicine ORENCIA ® (abatacept), KINERET ® (anakinra), RITUXAN ® (rituximab), IMURAN ® (azathioprine), or PURINETHOL ® (6–mercaptopurine, 6-MP). are scheduled to have major surgery.

After starting YUFLYMA, call your doctor right away if you have an infection, or any sign of an infection. YUFLYMA can make you more likely to get infections or make any infection that you may have worse. Cancer For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including YUFLYMA, the chances of getting cancer may increase.

There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers. People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. If you use TNF blockers including YUFLYMA, your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin).

These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that does not heal. Some people receiving TNF blockers including YUFLYMA developed a rare type of cancer called hepatosplenic T-cell lymphoma.

This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN ® (azathioprine) or PURINETHOL ® (6-mercaptopurine, 6–MP).

What is YUFLYMA? YUFLYMA is a medicine called a Tumor Necrosis Factor (TNF) blocker. YUFLYMA is used: To reduce the signs and symptoms of: moderate to severe RA in adults.

YUFLYMA can be used alone, with methotrexate, or with certain other medicines. moderate to severe…

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