Tildrakizumab-asmn injection
Tildrakizumab-asmn is a targeted biologic injection used to treat moderate-to-severe plaque psoriasis in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Ilumya (tildrakizumab-asmn) is a biologic injection for adults with moderate-to-severe plaque psoriasis that blocks IL-23, an immune protein that drives the inflammation behind plaques. It is one of several biologics used when creams are not enough, has been on the U.S. market since about 2018 and is not available generically. Most people tolerate it well, and what they notice is usually a cold or sore throat, or mild redness and soreness where the shot goes in. The one thing to watch for is infection, so expect a TB (tuberculosis) test before starting and report fever, chills, a lingering cough or sores that will not heal.
Clinical pearls
- A healthcare provider gives every dose, so if an appointment slips, get the dose soon, then return to the regular schedule.
- Avoid live vaccines during treatment, and catch up on any recommended vaccines before the first injection.
- Mention any significant infection before your appointment, because the dose may be postponed until it clears.
- Night sweats, a persistent cough or unexplained weight loss during treatment can signal TB and need prompt attention.
Patient information guide A plain-language walkthrough of Tildrakizumab-asmn injection, written from its FDA label.
What Tildrakizumab-asmn injection is used for
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Tildrakizumab-asmn is a biologic injection approved for the following use:
- Ilumya is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy (whole-body drug treatment) or phototherapy (UV light treatment)
How Tildrakizumab-asmn injection works
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Tildrakizumab-asmn is a humanized monoclonal antibody — an engineered protein designed to act on one very specific target in the immune system. It binds to the p19 subunit of a protein called IL-23, blocking IL-23 from connecting to its receptor on immune cells. IL-23 is a naturally occurring signaling protein (cytokine) that promotes inflammation. By cutting off that signal, tildrakizumab-asmn reduces the release of other inflammation-driving proteins (proinflammatory cytokines and chemokines), which helps calm the abnormal immune activity that causes psoriasis plaques to form.
Tildrakizumab-asmn injection dosage
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Ilumya is given by subcutaneous injection (under the skin) and must be administered by a healthcare provider — it is not a self-injection. The general dosing schedule is an initial injection, a second injection four weeks later, and then one injection every 12 weeks after that. There are no food or drink restrictions. If a scheduled dose is missed, it should be given as soon as possible, and the regular every-12-week schedule then resumes from that point.
Dosing details from the FDA-approved label
From the Tildrakizumab-asmn injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Dosage (indication not named in the provided text)
- 100 mg by subcutaneous injection at Weeks 0, 4, and every 12 weeks thereafter
- If a dose is missed, administer as soon as possible, then resume the regularly scheduled interval
Read the label’s full dosing text
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 ) 2.1 Recommended 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 )] 2.2 Dosage 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. 2.3 Important 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. 2.4 Preparation 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.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Tildrakizumab-asmn injection side effects
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The most commonly reported side effects with Ilumya include:
Common side effects
- Upper respiratory infections (such as a common cold, sore throat, or stuffy nose)
- Injection site reactions (redness, pain, itching, or swelling at the shot site)
- Diarrhea
- Dizziness
- Pain in the extremities (arms or legs)
- Injection site reactions — redness, itching, pain, swelling, or bruising at the injection spot
When to get medical help
- Get emergency help if you have signs of a serious allergic reaction: swelling of the face, lips, or throat (angioedema), hives, or trouble breathing
- Call your doctor if you develop signs of infection: fever, chills, cough, shortness of breath, painful urination, or skin sores that won't heal
- Tell your doctor right away if you have symptoms of tuberculosis (TB): persistent cough, night sweats, or unexplained weight loss
Tildrakizumab-asmn injection warnings and precautions
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- Serious allergic reactions: Cases of angioedema (severe swelling under the skin) and urticaria (hives) have been reported. If a serious allergic reaction occurs, Ilumya must be stopped immediately and treated as a medical emergency.
- Infection risk: Ilumya may increase the risk of infections. Do not start Ilumya if you have a clinically significant active infection. People with chronic or recurrent infections should discuss the risks with their doctor before starting. If a serious infection develops during treatment, Ilumya may need to be paused.
- Tuberculosis (TB) screening: All patients must be tested for TB before starting Ilumya. Latent (inactive) TB must be treated before the first injection. Patients should be monitored for TB symptoms throughout treatment.
- Live vaccines: Live vaccines should not be given while on Ilumya. All recommended vaccines should be completed before starting treatment.
Tildrakizumab-asmn injection interactions
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Based on available evidence, Ilumya has a limited interaction profile, but one key concern stands out:
- Live vaccines: Avoid any live vaccine (such as live flu, yellow fever, or shingles vaccines) while on Ilumya — combining them may pose an infection risk or reduce vaccine effectiveness
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Tildrakizumab-asmn injection
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- Active infection: Do not start Ilumya until any significant active infection has been resolved or adequately treated
- TB history or latent TB: Must be screened and, if needed, treated for TB before starting Ilumya
- Chronic or recurrent infections: Discuss risks with your doctor before starting treatment
- Pregnancy: There is not enough data to confirm safety during pregnancy. Ilumya can cross the placenta; potential effects on the infant should be considered. A pregnancy registry is available for pregnant patients exposed to Ilumya.
- Breastfeeding: It is unknown whether Ilumya appears in human breast milk. Weigh the benefits of breastfeeding against the potential risks with your doctor.
- Children: Safety and effectiveness in patients under 18 have not been established; Ilumya is not approved for pediatric use
- Kidney or liver impairment: No formal studies have been conducted; tell your doctor if you have kidney or liver conditions
- Higher body weight: Drug levels in the body may be lower in people with higher body weight; your doctor is aware of this when prescribing
- Previous allergic reaction to tildrakizumab: Ilumya is contraindicated if you have had a serious hypersensitivity reaction to it or any of its ingredients
How your body processes Tildrakizumab-asmn injection
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After a subcutaneous (under-the-skin) injection, tildrakizumab-asmn is absorbed gradually, with peak blood levels reached in about 6 days. The drug reaches stable, steady-state concentrations in the body by around Week 16 of treatment. Its half-life — the time it takes the body to clear half the drug — is approximately 23 days, which is why injections are spaced 12 weeks apart once the initial doses are given. Like other monoclonal antibodies, it is broken down by the body into small peptides and amino acids in a process similar to how the body handles its own natural antibodies, rather than being processed by the liver's standard drug-metabolizing enzymes.
How to store Tildrakizumab-asmn injection
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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. protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Tildrakizumab-asmn injection
53 supplements and herbal products have documented interactions with Tildrakizumab-asmn injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Tildrakizumab-asmn injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Tildrakizumab-asmn injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Ilumya and what does it treat?
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How is Ilumya given, and do I inject it myself?
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What side effects should I expect, and which ones should I call about right away?
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Why do I need a TB test before starting Ilumya?
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Can I get vaccinated while I'm on Ilumya?
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Is Ilumya safe to use during pregnancy or while breastfeeding?
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Is Tildrakizumab-asmn injection available over the counter?
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When was Tildrakizumab-asmn injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Tildrakizumab-asmn injection on HelloPharmacist
Tildrakizumab-asmn injection forms and strengths (how it comes)
Tildrakizumab-asmn injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Ilumya is used to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
- Ilumya must be administered by a healthcare provider as a subcutaneous (under-the-skin) injection
- Ilumya is given at Week 0, again at Week 4, and then once every 12 weeks thereafter
- Ilumya prefilled syringes should be removed from the refrigerator and allowed to sit at room temperature for 30 minutes before injection
- Each Ilumya prefilled syringe is for single use only; inject the full 1 mL and discard any unused portion
Tildrakizumab-asmn injection on the U.S. market: products, makers and brands
How Tildrakizumab-asmn injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Tildrakizumab-asmn injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2018. Brand names on the directory include Ilumya; the rest are generics.
How widely Tildrakizumab-asmn injection is used (Medicaid data)
A general measure of how commonly Tildrakizumab-asmn injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tildrakizumab-asmn injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tildrakizumab-asmn injection prescribed? Of the 1,601 medications we measure, Tildrakizumab-asmn injection ranks #1,215 by Medicaid prescriptions — more than 24% of them.
Utilization by Tildrakizumab-asmn injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML tildrakizumab-asmn 100 MG/ML Prefilled Syringe
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2053453
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tildrakizumab-asmn injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Tildrakizumab-asmn injection NDCs with Medicaid activity.
Compare Tildrakizumab-asmn injection products
A representative set of FDA-listed product records for Tildrakizumab-asmn injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 100 mg/mL | Subcutaneous | Sun Pharmaceutical Industries, Inc. | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Tildrakizumab-asmn injection NDCs →
Tildrakizumab-asmn injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tildrakizumab-asmn injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tildrakizumab-asmn injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Tildrakizumab-asmn injection FDA approval history
How Tildrakizumab-asmn injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Tildrakizumab-asmn injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Tildrakizumab-asmn recalls since July 2021.
✅No Tildrakizumab-asmn recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2053436 1 dose form · 1 strength
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Dose form (SCDF) Prefilled Syringe RxCUI 2053452No current FDA listingClinical drug / strength (SCD) 1 ML tildrakizumab-asmn 100 MG/MLRxCUI 2053453
Look up RxCUI 2053436 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Tildrakizumab-asmn injection supply and shortage status
Whether Tildrakizumab-asmn injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Tildrakizumab-asmn injection brand names
Tildrakizumab-asmn injection is sold under one brand name in the FDA directory — Ilumya. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Tildrakizumab-asmn injection: manufacturers and labelers
One company lists Tildrakizumab-asmn injection products with the FDA. By number of product records, the largest are Sun Pharmaceutical Industries, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Tildrakizumab-asmn injection drug class (RxNorm)
Tildrakizumab-asmn injection belongs to the Interleukin-23 Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Tildrakizumab-asmn injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →