ICOTYDE icotrokinra 200 mg Tablet, Film Coated, 7-count
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Icotrokinra is used to treat certain types of plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body). Icotrokinra is in a class of medications called interleukin antagonists. It works by blocking the activity of interleukin, a substance in the body that causes inflammation.
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🧪 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.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII G7515SW10N
A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 23ZQ42JZZH
A synthetic polymer made by chemically linking polyvinyl alcohol to polyethylene glycol. It acts as a binder and film-former to hold tablet ingredients together and create smooth coatings on capsules or tablets.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII GRV5BG8C5N
A plant-based filler and binder made from cellulose combined with silica. It helps hold tablet ingredients together, improves flowability during manufacturing, and ensures consistent tablet density and shape.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Icotyde 200 mgthis 57894-0201-07 | Janssen | 7 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11939361 ↗ | Method of use | U-4447 | Nov 19, 2041 |
| US 11845808 ↗ | Drug substance | U-4447 | Jan 14, 2041 |
| US 12552836 ↗ | Drug substance | — | Jul 12, 2039 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Mar 17, 2031 |
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🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 57894-0201-07 You're viewing this | 1 BLISTER PACK in 1 CARTON (57894-201-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK (57894-201-01) | 2026-03-17 | Active |
| 57894-0201-30 | 1 BOTTLE in 1 CARTON (57894-201-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 2026-03-17 | Active |
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🧭 About this NDC listing & data coverage
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| 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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION See the full prescribing information for recommended evaluation and immunizations prior to treatment. ( 2.1 ) Recommended dosage is 200 mg orally once daily. ( 2.2 ) Administer ICOTYDE on an empty stomach with water upon waking. ( 2.2 ) Wait at least 30 minutes after taking ICOTYDE before eating food. ( 2.2 ) For patients who have difficulty swallowing tablets, ICOTYDE can be dispersed in water. ( 2.3 )
2.1Recommended Evaluation and Immunizations Prior to Treatment Initiation Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment [see Warnings and Precautions (5.2) ] . Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.3) ] .
2.2Recommended Dosage and Administration Instructions The recommended dosage of ICOTYDE is 200 mg administered orally once daily. Administer ICOTYDE upon waking on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.
Swallow ICOTYDE whole. Do not crush, split, or chew tablets [see Clinical Pharmacology (12.3) ] . If a patient misses a dose, instruct patients to take the missed dose as soon as possible with a return to normal dosing schedule the following day.
2.3Alternative Preparation and Administration Instructions for Patients Who Have Difficulty Swallowing Tablets ICOTYDE 200 mg tablet can also be dispersed in water using the following instructions: Place one ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water. It may take a few minutes for the tablet to disperse. The tablet may not completely disperse.
The mixture may look yellow, milky, or cloudy, and small pieces may be seen in the water which are safe to swallow. Gently swirl the cup before drinking and swallowing the full mixture. Add at least 120 mL (4 ounces) of additional water to the cup and completely swallow the contents to make sure the whole dose is taken.
Complete administration of ICOTYDE within 15 minutes of dispersion in water.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 200 mg of icotrokinra, yellowish orange to yellowish brown, oval, film-coated tablets debossed with '200' on one side and 'JNJ' on the other side. Tablets: 200 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections : Avoid treatment with ICOTYDE in patients with any clinically important active infection until the infection resolves or is adequately treated. If such an infection develops, discontinue ICOTYDE until the infection resolves. ( 5.1 ) Tuberculosis (TB) : Consider evaluating for TB prior to initiating treatment with ICOTYDE based on clinical judgment.
Monitor patients for signs and symptoms of active TB during and after treatment with ICOTYDE. ( 5.2 ) Immunizations : Avoid use of live vaccines during treatment with ICOTYDE. ( 5.3 )
5.1Infections Medicines that interact with the immune system may increase the risk of infection. In the 16-week placebo-controlled trials in subjects with moderate-to-severe plaque psoriasis, the rate of serious infections for ICOTYDE-treated subjects was 0.2% compared to 0.4% of subjects who received placebo. Avoid treatment with ICOTYDE 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 ICOTYDE. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection and/or is not responding to standard therapy, monitor the patient closely and discontinue ICOTYDE until the infection resolves.
5.2Tuberculosis Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment. Consider anti-TB therapy prior to initiating ICOTYDE in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after ICOTYDE treatment.
Avoid administering ICOTYDE to patients with active TB.
5.3Immunizations Avoid use of live vaccines in patients during treatment with ICOTYDE. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ICOTYDE, complete immunizations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (≥1%) are headache, nausea, cough, fungal infection, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ICOTYDE was evaluated in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4) and two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) [see Clinical Studies (14) ] . A total of 2367 adults and pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis received ICOTYDE 200 mg orally once daily.
Of these, 648 subjects were treated with ICOTYDE for at least one year. Data from these four trials were pooled to evaluate the safety of ICOTYDE compared to placebo for 16 weeks. Adverse Reactions Weeks 0 to 16 Table 1: Adverse Reactions that Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently than in the Placebo Group in Trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16 percentages based on Cochran-Mantel-Haenszel (CMH) adjusted proportions.
Adverse Reactions ICOTYDE N=1296 n (%) Placebo N=568 n (%) Headache 51 (4.1) 19 (3.3) Nausea 15 (1.2) 3 (0.5) Cough 15 (1.2) 1 (0.2) Fungal Infection Fungal infection includes tinea pedis (n=4), tinea versicolor (n=2), oral candidiasis (n=2), onychomycosis (n=1), skin candida (n=1), urinary tract candidiasis (n=1), vulvovaginal candidiasis (n=1), fungal skin infection (n=1), genital infection fungal (n=1), ear infection fungal (n=1), laryngitis fungal (n=1). Two subjects experienced more than 1 event. 14 (1.1) 0 (0) Fatigue 15 (1.0) 3 (0.5) Adverse reactions that occurred in < 1% of subjects in the ICOTYDE group and at a higher rate than in the placebo group through Week 16 in Trials PSO-1, PSO-2, PSO-3, and PSO-4 were: gastritis, abdominal discomfort, and one fatal case involving upper gastrointestinal bleeding in a subject with underlying risk factors.
A relationship of this event to ICOTYDE is not established. Adverse Reactions in Pediatric Subjects 12 Years of Age and Older The safety of ICOTYDE was evaluated in pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4). A total of 72 pediatric subjects were treated with ICOTYDE 200 mg orally once daily.
Of these, 45 subjects were treated with ICOTYDE for at least one year. The adverse reactions observed in pediatric subjects were consistent with the most common adverse reactions (≥ 1%) observed in the overall population.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Moderate or Severe Renal Impairment: Monitor for potential adverse reactions when ICOTYDE is used in patients with eGFR <60 mL/min. ( 8.6 )
8.1Pregnancy Risk Summary The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal reproduction study in rabbits, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs (see Data ) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and 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% to 4% and 15% to 20%, respectively.
There is a pregnancy safety study for ICOTYDE. If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com. Data Animal Data In an embryo-fetal development study, icotrokinra was administered to pregnant rats during the period of organogenesis at oral doses of 70, 200, and 1000 mg/kg/day.
No maternal or embryo-fetal toxicity was observed at doses up to 1000 mg/kg/day (297 times the MRHD based on AUC comparison). In another embryo-fetal development study, icotrokinra was administered to pregnant rabbits during the period of organogenesis at oral doses of 50, 200, and 500 mg/kg/day. Maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs were observed at 500 mg/kg/day (157 times the MRHD based on AUC comparison).
No maternal or embryo-fetal toxicity was noted at doses up to 200 mg/kg/day in rabbits (27 times the MRHD based on AUC comparison). In a pre- and post-natal development study in rats, icotrokinra was administered to pregnant rats during pregnancy and lactation periods at oral doses of 20, 70, and 200 mg/kg/day. No maternal or developmental toxicity was noted in doses up to 200 mg/kg/day (127 times the MRHD based on AUC comparison).
8.2Lactation Risk Summary There are no data on the presence of icotrokinra in human milk, the effects on the breastfed infant, or the effects on milk production. When administered to lactating rats, icotrokinra was detected in the plasma of nursing pups (see Data ) . When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ICOTYDE and any potential adverse effects on the breastfed infant from ICOTYDE or from the underlying maternal condition. Data In a pre- and post-natal development study in rats, icotrokinra was administered orally to pregnant rats during pregnancy and lactation periods at doses up to 200 mg/kg/day (127 times the MRHD based on AUC comparison). Although not directly measured in rat milk, icotrokinra was detected in the plasma of nursing rat pups.
No adverse developmental effects were observed in the nursing pups.
8.4Pediatric Use The safety and effectiveness of ICOTYDE have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Use of ICOTYDE for this indication is supported by evidence from two multi-center, randomized 52-week trials (Trial PSO-3 and Trial PSO-4) conducted in adults and pediatric subjects, including 72 pediatric subjects 12 years of age and older treated with ICOTYDE [see Adverse Reactions (6.1) and Clinical…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal reproduction study in rabbits, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs (see Data ) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and 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% to 4% and 15% to 20%, respectively.
There is a pregnancy safety study for ICOTYDE. If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com. Data Animal Data In an embryo-fetal development study, icotrokinra was administered to pregnant rats during the period of organogenesis at oral doses of 70, 200, and 1000 mg/kg/day.
No maternal or embryo-fetal toxicity was observed at doses up to 1000 mg/kg/day (297 times the MRHD based on AUC comparison). In another embryo-fetal development study, icotrokinra was administered to pregnant rabbits during the period of organogenesis at oral doses of 50, 200, and 500 mg/kg/day. Maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs were observed at 500 mg/kg/day (157 times the MRHD based on AUC comparison).
No maternal or embryo-fetal toxicity was noted at doses up to 200 mg/kg/day in rabbits (27 times the MRHD based on AUC comparison). In a pre- and post-natal development study in rats, icotrokinra was administered to pregnant rats during pregnancy and lactation periods at oral doses of 20, 70, and 200 mg/kg/day. No maternal or developmental toxicity was noted in doses up to 200 mg/kg/day (127 times the MRHD based on AUC comparison).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ICOTYDE have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Use of ICOTYDE for this indication is supported by evidence from two multi-center, randomized 52-week trials (Trial PSO-3 and Trial PSO-4) conducted in adults and pediatric subjects, including 72 pediatric subjects 12 years of age and older treated with ICOTYDE [see Adverse Reactions (6.1) and Clinical Studies (14) ].
The safety and effectiveness of ICOTYDE in pediatric patients younger than 12 years of age or who weigh less than 40 kg have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 2367 subjects exposed to ICOTYDE in clinical trials for moderate-to-severe plaque psoriasis, 240 (10.1%) were 65 years of age and older, and 36 (1.5%) were 75 years of age and older. No overall differences in safety and effectiveness of ICOTYDE have been observed between subjects 65 years of age and older and younger adult subjects [see Clinical Studies (14) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Icotrokinra is a peptide that selectively binds to the IL-23 receptor (IL-23R) with a dissociation constant of 7 pM and antagonizes the binding of IL-23. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Icotrokinra inhibits the IL-23/IL-23R-dependent release of proinflammatory cytokines.
12.2Pharmacodynamics Icotrokinra reduced serum levels of proinflammatory cytokines, IL-17A, IL-17F, IL-19, IL-22 and β-defensin-2, relative to pretreatment levels in evaluated subjects with moderate-to-severe plaque psoriasis based on exploratory analysis of the pharmacodynamic markers. A decrease from baseline was observed in the expression of mRNA related to IL-23/Th17 pathway and psoriasis, including molecular targets IL17A , IL17F , IL19 , IL22 , IL23A , and DEFB4A , in lesional skin biopsies up to 24 weeks post treatment in an exploratory analysis of subjects with moderate-to-severe plaque psoriasis.
The relationship between these pharmacodynamic markers and the mechanism(s) by which icotrokinra exerts its clinical effects is not fully understood. Cardiac Electrophysiology At 5 times the maximum recommended dose of ICOTYDE, clinically significant QTc interval prolongation was not observed.
12.3Pharmacokinetics Following the administration of icotrokinra 200 mg, the mean (standard deviation) maximum concentration (C max ) is 3.62 (1.48) ng/mL and total systemic exposure (AUC inf ) is 44.8 (11.4) ng*h/mL. Icotrokinra C max and AUC increase in a dose-proportional manner between 0.05 to 5 times the recommended dosage in healthy subjects. Following multiple dose administration accumulation for C max was up to 1.6-fold and for AUC was up to 1.5-fold.
Icotrokinra steady state is reached in approximately 3 days. No clinically relevant differences in icotrokinra pharmacokinetics were observed between healthy subjects and patients with moderate-to-severe plaque psoriasis. Absorption Icotrokinra median (min, max) time to maximum plasma concentration (T max ) is 2 (0.25, 8) hours.
Effect of Food Icotrokinra AUC decreased by 43% and C max decreased by 59% following administration with a high-fat meal (1000 calories, 50% fat) [see Dosage and Administration (2.2) ]. No clinically significant differences in icotrokinra pharmacokinetics were observed following administration of caffeine. Distribution Icotrokinra is 52% bound to plasma protein.
Blood to plasma partition ratio is 0.53. Icotrokinra steady state apparent (oral) volume of distribution is 92800 L. Elimination Icotrokinra median elimination half-life is 12 hours with an apparent (oral) clearance of 6550 L/h.
Metabolism Icotrokinra is a peptide and it is metabolized by peptide catabolism into smaller peptides. Excretion Following oral administration of icotrokinra to healthy subjects, approximately 37% to 81% of the dose was recovered in feces within 24 hours as unchanged icotrokinra, and 0.001% of the dose was recovered in urine as unchanged icotrokinra. Specific Populations No clinically significant differences in the pharmacokinetics of icotrokinra were observed based on age (range: 12 to 87 years), body weight (range: 39 to 211 kg), sex, race (76% White, 20.1% Asian, 1.7% Black), ethnicity, immunogenicity, mild (eGFR ≥60 to <90 mL/min, [calculated according to Chronic Kidney Disease Epidemiology Collaboration]) renal impairment.
The effect of mild (Child-Pugh Class A) to severe (Child-Pugh Class C) hepatic impairment on icotrokinra pharmacokinetics is unknown. Hepatic impairment is unlikely to affect icotrokinra elimination since the drug is not metabolized hepatically. However, patients with severe hepatic impairment were not studied in clinical trials.
Pediatric Patients No clinically relevant differences in icotrokinra pharmacokinetics were observed in pediatric patients with moderate-to-severe plaque psoriasis 12 years of age and older who weigh at least 40 kg compared to adults. Patients wit…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Icotrokinra is a peptide that selectively binds to the IL-23 receptor (IL-23R) with a dissociation constant of 7 pM and antagonizes the binding of IL-23. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Icotrokinra inhibits the IL-23/IL-23R-dependent release of proinflammatory cytokines.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ICOTYDE™ (icotrokinra) tablets: 200 mg, yellowish orange to yellowish brown, oval, film-coated tablets debossed with '200' on one side and 'JNJ' on the other side. ICOTYDE is supplied in bottles of 30 tablets (NDC Number: 57894-201-30), with a silica gel desiccant and a child-resistant closure. Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].
Store in original package to protect from moisture. Do not discard desiccant.
📦 Storage and Handling ▾
Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. Store in original package to protect from moisture. Do not discard desiccant.
📋 Description ▾
11 DESCRIPTION Icotrokinra is an IL-23 receptor antagonist, in the form of a hydrochloride salt. Icotrokinra is a 13-amino acid peptide. The molecular formula for icotrokinra is C 90 H 120 N 20 O 22 S 2 and its molecular weight is 1898.17.
The chemical name for icotrokinra is (4S)-4-[([4-[(2S)-2-[(2S)-2-[([(4R,7S,10S,13S,16S,19R)-19-acetamido-7-(4-acetamidobutyl)-16-(2-amino-2-oxoethyl)-13-[(1R)-1-hydroxyethyl]-3,3,20,20-tetramethyl-10-[(7-methyl-1H-indol-3-yl)methyl]6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl)amino]-3-[4-(2-aminoethoxy)phenyl]propanamido]-3-(2-naphthyl)propanamido]tetrahydro-2H-pyran-4-yl]carbonyl)amino]-5-[[(2S)-4-amino-1-[[(2S)-1-[(2-amino-2-oxoethyl)(methyl)amino]-1-oxo-3-(pyridin-3-yl)propan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-5-oxopentanoic acid.
The structural formula for icotrokinra hydrochloride is: Icotrokinra hydrochloride is a white to almost white powder. It is freely soluble below pH 2, very slightly soluble at pH 5, practically insoluble at pH 9, and freely soluble above pH 11. The isoelectric point (pI) of the compound is 7.15.
ICOTYDE™ (icotrokinra) tablets are supplied as 200 mg film-coated tablets for oral administration. Each tablet of ICOTYDE contains 200 mg icotrokinra (equivalent to 201.6–202.8 mg of icotrokinra hydrochloride) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and silicified microcrystalline cellulose. The film coating contains the following inactive ingredients: glyceryl monocaprylocaprate, iron oxide yellow, macrogol polyvinyl alcohol graft polymer, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infections Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions (5.1) ] . Tuberculosis Advise patients to contact their healthcare provider if they experience symptoms suggestive of TB (e.g., unexplained fever, cough, or difficulty breathing) [see Warnings and Precautions (5.2) ] .
Immunizations Instruct patients to inform their healthcare provider that they are taking ICOTYDE prior to a potential vaccination [see Warnings and Precautions (5.3) ] . Dosage and Administration Instruct patients to take ICOTYDE once daily upon waking on an empty stomach with water. Instruct patients to wait at least 30 minutes after taking ICOTYDE before eating food [see Dosage and Administration (2.2) ] .
Instruct patients who have trouble swallowing tablets to disperse the tablet in water [see Dosage and Administration (2.3) ] . Pregnancy Advise pregnant women that there is a pregnancy safety study that monitors pregnancy outcomes in women exposed to ICOTYDE during pregnancy, and they can be enrolled by calling 1-800-526-7736 or www.ICOTYDE.com [see Use in Specific Populations (8.1) ].
💬 Medication Guide ▾
MEDICATION GUIDE ICOTYDE™ (ai-koh-tide) (icotrokinra) tablets, for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 3/2026 What is the most important information I should know about ICOTYDE?
Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE 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 ICOTYDE. Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including: fever, sweat, or chills cough shortness of breath blood in your mucus (phlegm) 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 ICOTYDE?" for more information about side effects.
What is ICOTYDE? ICOTYDE is a prescription medicine used to treat moderate-to-severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). It is not known if ICOTYDE is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40 kg).
Before taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you: have an infection that does not go away or that keeps coming back. have tuberculosis (TB) or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE. have kidney problems. are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.
Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby.
If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com. are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take ICOTYDE? Take ICOTYDE exactly as your healthcare provider tells you to take it.
Take ICOTYDE 1 time a day. Take ICOTYDE when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.
Swallow ICOTYDE tablets whole. Do not crush, split, or chew ICOTYDE tablets. If you cannot swallow ICOTYDE tablets whole: Place 1 ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water.
Wait a few minutes for the tablet to break up (disperse) in the water. The tablet may not completely disperse. The mixture may look yellow, milky, or cloudy.
Small pieces may be seen in the water, which are safe to swallow. Gently swirl the cup before swallowing the mixture. Add at least 120 mL (4 ounces) of additional water to the cup and completely swallow all of the mixture to make sure that you take your full dose of ICOTYDE.
Take the ICOTYDE and water mixture within 15 minutes of preparation. If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day. What are the possible side effects of ICOTYDE?
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