Icotyde (icotrokinra) is filed as IL-23 receptor antagonist. The sections below restate public label fields stored for this profile.
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 )
12.1 Mechanism 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.
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 ) 5.1 Infections 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. 5.2 Tuberculosis 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. 5.3 Immunizations 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.
4 CONTRAINDICATIONS None. None. ( 4 )
Headache (≥1%); Nausea (≥1%); Cough (≥1%); Fungal infection (≥1%); Fatigue (≥1%)
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 . 6.1 Clinical 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.
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 ) 2.1 Recommended 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) ] . 2.2 Recommended 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. 2.3 Alternative 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.
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) ].
According to its FDA label, Icotyde (icotrokinra) is approved for: 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)… For medical advice, please talk to your prescriber or pharmacist.
Icotyde (icotrokinra) belongs to the IL-23 receptor antagonist class of medications.
The FDA label lists Icotyde (icotrokinra) as: 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 ); oral route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Icotyde. Availability changes as patents expire.
Our ingest of the FDA label for Icotyde (icotrokinra) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Icotyde (icotrokinra) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Icotyde (icotrokinra) as 2026-03-17.
The FDA label lists Janssen Biotech, Inc. as a labeler/manufacturer of Icotyde (icotrokinra). Multiple firms may market generics of the same molecule.
The FDA label states: "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 no…" Follow the packaging insert for the authoritative guidance.
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