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ILUMYA tildrakizumab-asmn 100 mg/mL Injection, Solution, 1 mL — NDC 47335-0177-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ILUMYA tildrakizumab-asmn 100 mg/mL Injection, Solution, 1 mL — NDC 47335-177-10 (Billing 47335-0177-10)

by Sun Pharmaceutical Industries, Inc. · 1 mL in 1 CARTON

This is a package of 1 mL of ILUMYA tildrakizumab-asmn 100 mg/mL Injection, Solution from Sun Pharmaceutical Industries, Inc., marketed since Aug 2018 and currently FDA-listed.

NDC 47335-0177-10
🏷️ FDA NDC (as labeled) 47335-177-10 billing pads the product segment with a zero
This package
Contains1 mL Pack sizes4 compare ↓
Also priced by: Part D plans $18,247.38/unit — full pricing hub ↓
Product page 47335-0177-95 Also comes in: 1 ml 47335-177-01 1 ml 47335-177-95 1 ml 47335-177-96
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 47335-177-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
47335 labeler · 177 product · 10 package
Package marketed since
Aug 6, 2018
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Billing quantity
1 mL per package
Barcode (UPC-A, from the NDC)
3 4733517710 7
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 47335-177-10
Product NDC 47335-177
11-digit billing NDC 47335017710
NCPDP billing unit ML — per mL (volume)
Application # BLA761067
SPL Set ID c6a322bb-51b9-4f0e-8642-62a9682ffcde
Established class (EPC) Interleukin-23 Antagonist
Mechanism of action Interleukin-23 Antagonists
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-08-06
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance TILDRAKIZUMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 078258
GCN 44553
HICL code 044823
Ingredient (HICL) Tildrakizumab-Asmn
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L1
Therapeutic class — intermediate (HIC2) Drugs To Treat Specific Top Diseases (Systemic)
HIC3 code L1A
Therapeutic class — specific (HIC3) Antipsoriatic Agents,Systemic
AHFS code 84:06.28.00
AHFS class Immunomodulatory Agents (84:06)
FDB label name ILUMYA 100 MG/ML SYRINGE
FDB brand name Ilumya
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078258
  • GCN: 44553
  • HICL (First Databank): 044823
  • AHFS class code: 84:06.28.00
Why two NDCs? The FDA registers this code as 47335-177-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 47335-0177-10. 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.

Clinical

Label name ILUMYA 100 MG/ML SYRINGE Ingredient Tildrakizumab-Asmn
📖 What it is MedlinePlus · NLM

Tildrakizumab-asmn injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in people whose psoriasis is too severe to be treated by topical medications alone. Tildrakizumab-asmn injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain natural substances in the body that cause the symptoms of psoriasis.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats moderate-to-severe plaque psoriasis in adults. It's meant for people who are candidates for systemic therapy or phototherapy. It works by blocking IL-23, a protein involv...
  • What is tildrakizumab-asmn (Ilumya) used for?
  • It's given under the skin by a healthcare provider. You get a first dose, a second dose 4 weeks later, and then a dose every 12 weeks. Follow the schedule your prescriber sets.
  • Have the dose given as soon as you can. After that, you go back to your regular schedule. Call your provider's office to set up the visit.
📖 Read our full Tildrakizumab-asmn injection guide →
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.

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 mLPer 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 $18,247.38 $18,247.38 / 1 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
47335-0177-01 47335-177-01 1 mL in 1 SYRINGE, GLASS Sample 2018-08-06 — Active
47335-0177-10 You're viewing this 1 mL in 1 CARTON Sample 2018-08-06 — Active
47335-0177-95 47335-177-95 Main listing 1 mL in 1 CARTON 2018-08-06 — Active
47335-0177-96 47335-177-96 1 mL in 1 SYRINGE, GLASS 2018-08-06 — Active

This pack shows little to no recent Medicaid volume — the 1 ml pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 mL — 1 ml in 1 carton.
How does this package differ from NDC 47335-0177-01?
Both are ILUMYA tildrakizumab-asmn 100 mg/mL Injection, Solution — the drug itself is identical. This page's package is the 1 mL one, while NDC 47335-0177-01 is the 1 ml package.
What NDC number is used to bill for this package of ILUMYA tildrakizumab-asmn 100 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ilumya 100 mg/mLthis 47335-0177-10 Sun 1 ml — — FDA listed —
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

🏛️
2018
First FDA approval
Mar 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2030. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 20, 2018 ⏳ ~3.4 yr to latest listed protection

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
Ilumyatildrakizumab-asmn
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2018 2020 2022 2024 2026 2028 2030
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 dateMar 20, 2030
Common questions
Is there a biosimilar for ILUMYA 100 MG/ML SYRINGE?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
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.

What it looks like

Color Yellow
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.

🧪 Avoiding an ingredient? See Tildrakizumab-asmn injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.495 mg / 1 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 1.42 mg / 1 mL UNII 1D5Q932XM6
    An amino acid salt used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in liquid formulations to keep the drug stable and effective.
  • 0.5 mL / 1 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 70 mg / 1 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 1 mL / 1 mL UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 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.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
FDA applicationBLA761067 (BLA)
Labeler code47335
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio891 products on file

More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 47335

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 51 words ▾

1 INDICATIONS AND USAGE ILUMYA ® is indicated for the treatment of moderate-to-severe plaque psoriasis in aduts who are candidates for systemic therapy or phototherapy. ILUMYA is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION See the full prescribing information for recommended evaluations and immunizations prior to treatment. ( 2.1 ) Administer by subcutaneous injection. ( 2.2 ) Recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. ( 2.2 )

2.1Recommended Evaluation and Immunization Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA [see Warnings and Precautions ( 5.3 )] . Consider completion of all age appropriate immunizations according to current immunization guidelines. [see Warnings and Precautions ( 5.4 )]

2.2Dosage ILUMYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.

2.3Important Administration Instructions ILUMYA should only be administered by a healthcare provider. Administer ILUMYA subcutaneously. Each prefilled syringe is for single-dose only. Inject the full amount (1 mL), which provides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

2.4Preparation and Administration of ILUMYA Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes. Follow the instructions on the ILUMYA carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.

Inspect ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged.

Air bubbles may be present; there is no need to remove them. Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.

Also, do not inject into scars, stretch marks, or blood vessels. While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard. Inject ILUMYA subcutaneously as recommended [see Dosage and Administration (2.3) ] .

Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given. Remove the needle from the skin entirely before letting go of the blue plunger.

After the blue plunger is released, the safety lock will draw the needle inside the needle guard. Discard any unused portion. Dispose of used syringe. image-1 image-2 image-3

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 mg/mL solution in a single-dose prefilled syringe. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution. Injection: 100 mg/mL solution in a single-dose prefilled syringe. ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients [see Warnings and Precautions (5.1) ]. Serious hypersensitivity reaction to tildrakizumab or to any of the excipients. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity: If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. ( 5.1 ) Infections : ILUMYA may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.

If a serious infection develops, consider discontinuing ILUMYA until the infection resolves. ( 5.2 ) Pretreatment Evaluation for Tuberculosis (TB): Evaluate for TB prior to initiating treatment. ( 5.3 ) Immunizations : Avoid use of live vaccines.

( 5.4 )

5.1Hypersensitivity Cases of angioedema and urticaria occurred in ILUMYA treated subjects in clinical trials. If a serious hypersensitivity reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy [see Adverse Reactions (6.1) ].

5.2Infections ILUMYA may increase the risk of infection. Although infections were more common in the ILUMYA group (23%), the difference in frequency of infections between the ILUMYA group and the placebo group (22%) was less than 1% during the placebo-controlled period. However, subjects with active infections or a history of recurrent infections were not included in clinical trials.

Upper respiratory infections occurred more frequently in the ILUMYA group than in the placebo group [see Adverse Reactions (6.1) ] . The rates of serious infections for the ILUMYA group and the placebo group were ≤0.3%. Treatment with ILUMYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ILUMYA. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and consider discontinuation of ILUMYA until the infection resolves [see Adverse Reactions (6.1) ] .

5.3Pretreatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Initiate treatment of latent TB prior to administering ILUMYA. In clinical trials, of 55 subjects with latent TB who were concurrently treated with ILUMYA and appropriate TB prophylaxis, no subjects developed active TB (during the mean follow-up of 56.5 weeks).

One other subject developed TB while receiving ILUMYA. Monitor patients for signs and symptoms of active TB during and after ILUMYA treatment. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Do not administer ILUMYA to patients with active TB infection.

5.4Immunizations Prior to initiating therapy with ILUMYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with ILUMYA. No data are available on the response to live or inactive vaccines.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Most common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis In clinical trials, a total of 1994 subjects with plaque psoriasis were treated with ILUMYA, of which 1083 subjects were treated with ILUMYA 100 mg. Of these, 672 subjects were exposed for at least 12 months, 587 for 18 months, and 469 for 24 months.

Data from three placebo-controlled trials (Trials 1, 2, and 3) in 705 subjects (mean age 46 years, 71% males, 81% white) were pooled to evaluate the safety of ILUMYA (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 12 weeks [Q12W]) [see Clinical Studies (14) ] . Placebo-Controlled Period (Weeks 0-16 of Trial 1 and Weeks 0-12 of Trials 2 and 3) Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the ILUMYA group than in the placebo group. Table 1: Adverse Reactions Occurring in ≥1% of Subjects in the ILUMYA Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Trials 1, 2, and 3 * Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, and pharyngitis. † Injection site reactions include injection site urticaria, pruritus, pain, reaction, erythema, inflammation, edema, swelling, bruising, hematoma, and hemorrhage.

Adverse Reaction ILUMYA Placebo 100 mg (N=705) (N=355) N (%) N (%) Upper respiratory infections* 98 (14) 41 (12) Injection site reactions † 24 (3) 7 (2) Diarrhea 13 (2) 5 (1) During the placebo-controlled period of Trials 1, 2, and 3, adverse reactions that occurred at rates less than 1% but greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity. Cases of angioedema and urticaria were reported in ILUMYA-treated subjects in clinical trials . Safety through Week 260 The safety profile of ILUMYA through Week 260 of the open-label extension periods of Trial 2 and Trial 3 was consistent with the safety profile observed during the double-blind periods .

Psoriasis of the Scalp The safety of ILUMYA was assessed in a multicenter, randomized, double-blind, placebo-controlled trial (Trial 4) in 231 subjects with psoriasis of the scalp [ see Clinical Studies (14) ]. No new safety signals were identified through follow-up to Week 72. Psoriasis of the Nail The safety of ILUMYA was assessed in a multicenter, randomized, double-blind, placebo-controlled trial (Trial 5) in 99 subjects with psoriasis of the nail [ see Clinical Studies (14) ].

No new safety signals were identified through Week 28.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while being treated with ILUMYA during pregnancy. These patients can enroll in this registry by calling MotherToBaby a service of the Organization of Teratology Information Specialists (OTIS) at 1-866-626-6847 or by visiting the website https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn. Risk Summary Available data from clinical trials, published literature, and pharmacovigilance with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations). An embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (MRHD). When dosing was continued until parturition, an increase in neonatal death was observed at 59 times the MRHD (see Data).

The clinical significance of this nonclinical finding is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.

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 Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ILUMYA may be present in infants exposed in utero .

The potential clinical impact of tildrakizumab exposure in infants exposed in utero should be considered. Data Animal Data In an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestation day 118 (22 days from parturition). No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison).

Tildrakizumab crossed the placenta in monkeys. In a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks from gestation day 50 to parturition. Neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kg dose (6 times the MRHD based on AUC comparison), and four monkeys at 100 mg/kg dose (59 times the MRHD based on AUC comparison).

The clinical significance of these nonclinical findings is unknown. No tildrakizumab-related adverse effects were noted in the remaining infants from birth through 6 months of age.

8.2Lactation Risk Summary There are no data on the presence of tildrakizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. Tildrakizumab was detected in the milk of monkeys [ see Data ] .

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ILUMYA and any potential adverse effects on the breastfed child from ILUMYA or from the underlying maternal condition. Data Animal Data Tildrakizumab was detected in breast milk of monkeys in the pre- and postnatal developmental study described in 8.1. The mean tildrakizumab concentrations in milk were approximately 0.09 – 0.2% of that in serum on postpartum days 28 and 91.

8.4Pediatric Use Safety and effectiveness of ILUMYA in pediatric patients (<18 years of age) have not been established.

8.5Geriatric Use A to… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while being treated with ILUMYA during pregnancy. These patients can enroll in this registry by calling MotherToBaby a service of the Organization of Teratology Information Specialists (OTIS) at 1-866-626-6847 or by visiting the website https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn. Risk Summary Available data from clinical trials, published literature, and pharmacovigilance with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations). An embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (MRHD). When dosing was continued until parturition, an increase in neonatal death was observed at 59 times the MRHD (see Data).

The clinical significance of this nonclinical finding is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown.

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 Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ILUMYA may be present in infants exposed in utero .

The potential clinical impact of tildrakizumab exposure in infants exposed in utero should be considered. Data Animal Data In an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestation day 118 (22 days from parturition). No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison).

Tildrakizumab crossed the placenta in monkeys. In a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks from gestation day 50 to parturition. Neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kg dose (6 times the MRHD based on AUC comparison), and four monkeys at 100 mg/kg dose (59 times the MRHD based on AUC comparison).

The clinical significance of these nonclinical findings is unknown. No tildrakizumab-related adverse effects were noted in the remaining infants from birth through 6 months of age.

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use Safety and effectiveness of ILUMYA in pediatric patients (<18 years of age) have not been established.

🧓 Geriatric Use 78 words ▾

8.5Geriatric Use A total of 1083 subjects were exposed to ILUMYA 100 mg during Phase 2 and 3 trials. A total of 92 subjects were 65 years or older, and 17 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they responded differently from younger subjects [see Clinical Pharmacology (12.3) ] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

12.2Pharmacodynamics No formal pharmacodynamics studies have been conducted with ILUMYA.

12.3Pharmacokinetics Tildrakizumab pharmacokinetics increases proportionally over a dose range from 50 mg to 200 mg (0.5 to 2 times the approved recommended dosage) following subcutaneous administration in subjects with plaque psoriasis. Steady-state concentrations were achieved by Week 16 following subcutaneous administration of tildrakizumab at Weeks 0, 4, and every 12 weeks thereafter. At the 100 mg dose at Week 16, the mean (± SD) steady-state trough concentrations ranged from 1.22 ± 0.94 mcg/mL to 1.47 ± 1.12 mcg/mL.

The geometric mean (CV%) steady-state C max was 8.1 mcg/mL (34%). Absorption The absolute bioavailability of tildrakizumab was estimated to be 73-80% following subcutaneous injection. The peak concentration (C max ) was reached by approximately 6 days.

Distribution The geometric mean (CV%) volume of distribution is

10.8L (24%). Elimination The geometric mean (CV%) systemic clearance was

0.32L/day (38%) and the half-life was approximately 23 days (23%). Metabolism The metabolic pathway of tildrakizumab has not been characterized. As a humanized IgG1/k monoclonal antibody, tildrakizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.

Specific Populations No clinically significant differences in the pharmacokinetics of tildrakizumab were observed based on age (≥18 years). No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of tildrakizumab. Body Weight Tildrakizumab concentrations were lower in subjects with higher body weight.

Drug Interaction Studies Cytochrome P450 Substrates The AUC inf of dextromethorphan (CYP2D6 substrate) increased by 20% when used concomitantly with tildrakizumab 200 mg (two times the approved recommended dose) administered subcutaneously at Weeks 0 and 4 in subjects with plaque psoriasis. No clinically significant changes in AUC inf of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate) were observed.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of ILUMYA or of other tildrakizumab products. In pooled Phase 2b and Phase 3 analyses, 6.5% (26/400) of subjects treated with tildrakizumab 100 mg up to week 64 developed antibodies to tildrakizumab.

Of the subjects who developed antibodies to tildrakizumab, 38.4% (10/26 subjects) had neutralizing antibodies. This represents 2.5% (10/400) of all subjects receiving tildrakizumab. In pooled Phase 3 analyses, 8.3% (51/615) of subjects treated with tildrakizumab 100 mg dose up to 420 weeks developed antibodies to tildrakizumab.

Of the tildrakizumab-treated subjects who developed antibodies to tildrakizumab, 37.3% (19/51 subjects) had antibodies that were classified as neutralizing, which represents 3.0% (19/615) of all tildrakizumab-treated subjects. Development of neutralizing antibodies to tildrakizumab was associated with lower serum tildrakizumab concentrations. Subjects with neutralizing antibodies had numerically lower efficacy; however, the full impact of neutralizing antibodies on efficacy could not be adequately assessed.

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

📦 How Supplied / Storage and Handling 139 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ILUMYA (tildrakizumab-asmn) Injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA is supplied as one single-dose prefilled syringe per carton that delivers 1 mL of a 100 mg/mL solution. NDC 47335-177-95 Each prefilled syringe is equipped with a passive needle guard and a needle cover.

Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

ILUMYA can be kept at room temperature at 25°C (77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. If not used within 30 days, discard ILUMYA.

Do not store ILUMYA above 25°C (77°F).

📋 Description 125 words ▾

11 DESCRIPTION Tildrakizumab-asmn is a humanized IgG1/k antibody that specifically binds to the p19 subunit of interleukin-23 (IL-23). Tildrakizumab-asmn is produced in a recombinant Chinese hamster ovary (CHO) cell line and has an approximate molecular mass of 147 kilodaltons. ILUMYA (tildrakizumab-asmn) injection, for subcutaneous use, is a sterile, clear to slightly opalescent, colorless to slightly yellow solution.

ILUMYA is supplied in a single-dose prefilled syringe with a glass barrel and 29-gauge fixed, 1/2-inch needle. The syringe is fitted with a passive needle guard and a needle cover. Each 1 mL single-dose prefilled syringe contains 100 mg of tildrakizumab-asmn formulated in: L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and Water for Injection, USP with a pH of 5.7-6.3.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instruct patients and/or caregivers to read the Medication Guide before starting ILUMYA therapy and to reread the Medication Guide each time the prescription is renewed. Advise patients of the potential benefits and risks of ILUMYA.

Hypersensitivity Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.1) ]. Infections Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection [see Warnings and Precautions (5.2) ]. Immunizations Instruct patients to inform the healthcare practitioner that they are taking ILUMYA prior to a potential vaccination since the use of live vaccine is not recommended [see Warnings and Precautions (5.4) ].

Pregnancy Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ILUMYA during pregnancy [ see Use in Specific Populations, Pregnancy (8.1) ]. Manufactured by: Sun Pharmaceutical Industries Limited Mumbai, Maharashtra India 400 063 U.S. License No.

2092 U.S. Patent No. 8,404,813; 8,293,883 and 9,809,648 Tildrakizumab-asmn (active ingred.) Product of South Korea.

Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 ILUMYA is a registered trademark of Sun Pharmaceutical Industries Limited ©2026 Sun Pharmaceutical Industries Limited All rights reserved Rev. 07 2026 10009296-09

💬 Medication Guide ~3 min read ▾

Medication Guide ILUMYA ® (E-LOOM-ME-A) (tildrakizumab-asmn) injection, for subcutaneous use What is the most important information I should know about ILUMYA? ILUMYA may cause serious side effects, including: Serious allergic reactions. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: feel faint swelling of your face, eyelids, lips, mouth, tongue or throat skin rash trouble breathing or throat tightness chest tightness Infections.

ILUMYA is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with ILUMYA and may treat you for TB before you begin treatment with ILUMYA if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ILUMYA.

Tell your healthcare provider right away if you have an infection or develop symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your phlegm (mucus) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal See “What are the possible side effects of ILUMYA?” for more information about side effects. What is ILUMYA? ILUMYA is a prescription medicine used to treat moderate to severe plaque psoriasis in adults who may benefit from taking injections, pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

It is not known if ILUMYA is safe and effective in children under 18 years of age. Do not use ILUMYA if you have had a severe allergic reaction to tildrakizumab or any of the other ingredients in ILUMYA. See the end of this Medication Guide for a complete list of ingredients in ILUMYA.

Before receiving ILUMYA, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section “What is the most important information I should know about ILUMYA?” have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB recently received or are scheduled to receive a vaccine (immunization). You should avoid receiving live vaccines during treatment with ILUMYA. are pregnant or plan to become pregnant.

It is not known if ILUMYA can harm your unborn baby. There is a pregnancy exposure registry for women who become pregnant during treatment with or exposed to ILUMYA during pregnancy. If you become pregnant during treatment with ILUMYA, you can enroll in the pregnancy registry.

The purpose of this registry is to collect information about the health of women exposed to ILUMYA and their baby. Talk with your healthcare provider or call 1-866-626-6847 to enroll in this registry or visit https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn. are breastfeeding or plan to breastfeed. It is not known if ILUMYA passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive ILUMYA? ILUMYA should only be given to you by a healthcare provider.

ILUMYA is given as an injection under your skin (subcutaneous injection) in areas of your body such as your thighs, stomach area (abdomen), or upper arm. If you miss a follow-up appointment and do not receive your dose of ILUMYA, schedule another appointment as soon as possible. What are the possible side effects of ILUMYA?

ILUMYA may cause serious side effects. See “What is the most important information I should know about ILUMYA?” The most common side effects of ILUMYA include: upper respiratory infections injection site reactions diarrhea These are not all of the possible s… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Tildrakizumab pharmacokinetics increases proportionally over a dose range from 50 mg to 200 mg (0.5 to 2 times the approved recommended dosage) following subcutaneous administration in subjects with plaque psoriasis. Steady-state concentrations were achieved by Week 16 following subcutaneous administration of tildrakizumab at Weeks 0, 4, and every 12 weeks thereafter. At the 100 mg dose at Week 16, the mean (± SD) steady-state trough concentrations ranged from 1.22 ± 0.94 mcg/mL to 1.47 ± 1.12 mcg/mL.

The geometric mean (CV%) steady-state C max was 8.1 mcg/mL (34%). Absorption The absolute bioavailability of tildrakizumab was estimated to be 73-80% following subcutaneous injection. The peak concentration (C max ) was reached by approximately 6 days.

Distribution The geometric mean (CV%) volume of distribution is

10.8L (24%). Elimination The geometric mean (CV%) systemic clearance was

0.32L/day (38%) and the half-life was approximately 23 days (23%). Metabolism The metabolic pathway of tildrakizumab has not been characterized. As a humanized IgG1/k monoclonal antibody, tildrakizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.

Specific Populations No clinically significant differences in the pharmacokinetics of tildrakizumab were observed based on age (≥18 years). No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of tildrakizumab. Body Weight Tildrakizumab concentrations were lower in subjects with higher body weight.

Drug Interaction Studies Cytochrome P450 Substrates The AUC inf of dextromethorphan (CYP2D6 substrate) increased by 20% when used concomitantly with tildrakizumab 200 mg (two times the approved recommended dose) administered subcutaneously at Weeks 0 and 4 in subjects with plaque psoriasis. No clinically significant changes in AUC inf of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate) were observed.

🧬 Pharmacodynamics 11 words ▾

12.2Pharmacodynamics No formal pharmacodynamics studies have been conducted with ILUMYA.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Plaque Psoriasis In two multicenter, randomized, double-blind, placebo-controlled trials (Trial 2 [NCT01722331] and Trial 3 [NCT01729754]), 926 subjects received ILUMYA 100 mg (N=616) or placebo (N=310). Subjects had a Physician Global Assessment (PGA) score of ≥3 (moderate) on a 5-point scale of overall disease severity, Psoriasis Area and Severity Index (PASI) score ≥12, and a minimum body surface area (BSA) involvement of 10%. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded.

In both trials, subjects were randomized to either placebo or ILUMYA (100 mg at Week 0, Week 4, and every twelve weeks thereafter [Q12W]) up to 64 weeks. Trials 2 and 3 assessed the changes from baseline to Week 12 in the two co-primary endpoints: PASI 75, the proportion of subjects who achieved at least a 75% reduction in the PASI composite score. PGA of 0 (“cleared”) or 1 (“minimal”), the proportion of subjects with a PGA of 0 or 1 and at least a 2-point improvement.

Other evaluated outcomes in Trials 2 and 3 included the proportion of subjects who achieved a reduction from baseline in PASI score of at least 90% (PASI 90) and a reduction of 100% in PASI score (PASI 100) at Week 12 and maintenance of efficacy up to Week 64. In both trials, subjects in the ILUMYA 100 mg and placebo groups were predominantly men (69%) and White (80%), with a mean age of 46 years. At baseline, these subjects had a median affected BSA of 27%, a median PASI score of 17.8, and approximately 33% had a PGA score of 4 (“marked”) or 5 (“severe”).

Approximately 34% had received prior phototherapy, 39% had received prior conventional systemic therapy, and 18% had received prior biologic therapy for the treatment of psoriasis. Approximately 16% of subjects had a history of psoriatic arthritis. Clinical Response at Week 12 The results of Trials 2 and 3 are presented in Table 2.

Table 2 : Efficacy Results at Week 12 in Adults with Moderate-to-Severe Plaque Psoriasis in Trials 2 and 3 (NRI*) * NRI = Non-Responder Imputation † Co-Primary Endpoints ‡ PGA score of 0 (“cleared”) or 1 (“minimal”) Trial 2 ( NCT01722331) Trial 3 ( NCT01729754) ILUMYA 100 mg (N=309) n (%) Placebo (N=154) n (%) ILUMYA 100 mg (N=307) n (%) Placebo (N=156) n (%) PGA of 0 or 1 †,‡ 179 (58) 11 (7) 168 (55) 7 (4) PASI 75 † 197 (64) 9 (6) 188 (61) 9 (6) PASI 90 107 (35) 4 (3) 119 (39) 2 (1) PASI 100 43 (14) 2 (1) 38 (12) 0 (0) Examination of age, gender, race, and previous treatment with a biologic did not identify differences in response to ILUMYA among these subgroups at Week 12.

Maintenance of Response and Durability of Response In Trial 2, subjects originally randomized to ILUMYA and who were responders at Week 28 (i.e., PASI 75) were re-randomized to an additional 36 weeks of either maintaining the same dose of ILUMYA Q12W (every twelve weeks) or placebo. At Week 28, 229 (74%) subjects treated with ILUMYA 100 mg were PASI 75 responders. At Week 64, 84% of subjects who continued on ILUMYA 100 mg Q12W maintained PASI 75 compared to 22% of subjects who were re-randomized to placebo.

In addition, for subjects who were re-randomized and also had a PGA score of 0 or 1 at Week 28, 69% of subjects who continued on ILUMYA 100 mg Q12W maintained this response (PGA 0 or 1) at Week 64 compared to 14% of subjects who were re-randomized to placebo. For PASI 75 responders at Week 28 who were re-randomized to treatment withdrawal (i.e., placebo), the median time to loss of PASI 75 was approximately 20 weeks. In addition, for subjects who were re-randomized to placebo and also had a PGA score of 0 or 1 at Week 28, the median time to loss of PGA score of 0 or 1 was approximately 16 weeks.

Psoriasis of the Scalp In a multicenter, randomized, double-blind, placebo-controlled trial (Trial 4 [NCT03897088]) 231 subjects with moderate-to-severe psoriasis of the scalp (IGA Scalp score of 3 or 4) were treated subcutaneously with ILUMYA 100 mg (n=117) or placebo (n=114) at Weeks 0 and 4. Of t… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 76 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of ILUMYA. No effects on fertility parameters were observed in male or female cynomolgus monkeys that were administered tildrakizumab at subcutaneous or intravenous doses up to 140 mg/kg once every two weeks for 3 months (133 or 155 times the MRHD, respectively, based on AUC comparison). The monkeys were not mated to evaluate fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 73 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of ILUMYA. No effects on fertility parameters were observed in male or female cynomolgus monkeys that were administered tildrakizumab at subcutaneous or intravenous doses up to 140 mg/kg once every two weeks for 3 months (133 or 155 times the MRHD, respectively, based on AUC comparison). The monkeys were not mated to evaluate fertility.

📄 Package Label / Principal Display Panel 42 words ▾

Package/Label Display Panel NDC 47335-177-95 Rx only ILUMYA ® tildrakizumab-asmn injection 100 mg/mL For Subcutaneous Use Only Dispense the enclosed Medication Guide to each patient. Single-dose prefilled syringe. Discard unused portion. Sterile Solution - Contains No Preservative Sun Pharmaceutical Industries, Inc. image-4

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 ml47335-0177-95 1,692 Rx · $23,686,933
1 ml47335-0177-01 No Medicaid data
1 ml this page47335-0177-10 No Medicaid data
1 ml47335-0177-96 No Medicaid data
Drug total (last 4 qtrs): 1,692 Rx · 1,654 units · $23,686,933 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Ilumya — 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 Ilumya. 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
$14M
Claims incl. refills
784
Beneficiaries
691
Spend / beneficiary
$20,264.04
Spend / claim
$17,860.27
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 ml (47335-0177-01), 1 ml (47335-0177-95), 1 ml (47335-0177-96). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 47335-0171-49 · Sun 47335-0179-23 · Sun →
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.