{ "query": "deucravacitinib", "ingredient": "deucravacitinib", "slug": "deucravacitinib", "rxcui": "2612087", "brands": [ "Sotyktu" ], "names": [ "deucravacitinib" ], "classes": [ { "id": "L04AF", "name": "Janus-associated kinase (JAK) inhibitors" } ], "alternatives": [ "baricitinib", "deuruxolitinib", "ritlecitinib", "tofacitinib", "upadacitinib" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 1 }, "boxed_warning": "", "indications_and_usage": "is a tyrosine kinase 2 (TYK2) inhibitor indicated for: \u2022 the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants. \u2022 the treatment of active psoriatic arthritis in adults. ( 1.2 ) 1.1 Plaque Psoriasis SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use : SOTYKTU is not recommended for use in combination with other potent immunosuppressants. 1.2 Psoriatic Arthritis SOTYKTU is indicated for the treatment of active psoriatic arthritis in adults.", "contraindications": "is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU [see Warnings and Precautions (5.1) ] . History of hypersensitivity reaction to deucravacitinib or any of the excipients in SOTYKTU. ( 4 , 5.1 )", "warnings_and_cautions": "\u2022 Hypersensitivity Reactions: Hypersensitivity reactions, such as angioedema, have been reported. Discontinue if a clinically significant hypersensitivity reaction occurs. (5.1) \u2022 Infections: SOTYKTU may increase the risk of infection. Avoid use in patients with active or serious infection. If a serious infection develops, discontinue SOTYKTU until the infection resolves. (5.2) \u2022 Tuberculosis: Evaluate for latent or active TB prior to initiating treatment with SOTYKTU. (5.3) \u2022 Malignancy: Malignancies including lymphomas were observed in clinical trials with SOTYKTU. Consider the benefits and risks prior to initiating or continuing SOTYKTU in patients with a malignancy. (5.4) \u2022 Rhabdomyolysis and Elevated CPK: Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected . (5.5) \u2022 Laboratory Abnormalities: Periodically evaluate serum triglycerides. Evaluate liver enzymes at baseline and during SOTYKTU treatment in patients with known or suspected liver disease. (5.6) \u2022 Immunizations: Avoid use of SOTYKTU with live vaccines. (5.7) \u2022 Potential Risks Related to JAK Inhibition: It is not known whether TYK2 inhibition may be associated with the observed...", "warnings": "", "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of labeling: \u2022 Infections [see Warnings and Precautions (5.2) ] \u2022 Malignancy including Lymphomas [see Warnings and Precautions (5.4) ] \u2022 Elevated CPK [see Warnings and Precautions (5.5) ] \u2022 Laboratory Abnormalities [see Warnings and Precautions (5.6) ] Most common adverse reactions (\u2265 1%) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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. Plaque Psoriasis Clinical Trials The safety of SOTYKTU was evaluated in two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) and an open-label extension trial in which subjects who completed Trial PSO-1 or Trial PSO-2 could enroll [see Clinica...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Warnings and Precautions ( 5.8 ) 06/2026", "information_for_patients": "Advise patients to read the FDA-approved patient labeling (Medication Guide) before starting SOTYKTU therapy and each time the prescription is renewed, as there may be new information they need to know. Hypersensitivity Reactions Advise patients to discontinue SOTYKTU and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.1) ]. Infections Inform patients that SOTYKTU may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see Warnings and Precautions (5.2) ] . Inform patients that herpes infections, including serious infections, may occur with use of SOTYKTU [see Warnings and Precautions (5.2) ] . Malignancies including Lymphomas Inform patients that SOTYKTU may increase their risk of developing malignancies including lymphomas. Instruct patients to inform their healthcare provider if they have ever had any type of cancer [see Warnings and Precautions (5.4) ] . Rhabdomyolysis Inform patients that SOTYKTU may increase their risk of developing rhabdomyolysis. Instruct patients to immediat...", "spl_medguide": "MEDICATION GUIDE SOTYKTU\u2122 (soh-tik-too) (deucravacitinib) tablets What is the most important information I should know about SOTYKTU? SOTYKTU may cause serious side effects, including: \u2022 Serious allergic reactions. Stop taking SOTYKTU and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: o feel faint o swelling of your face, eyelids, lips, mouth, tongue, or throat o trouble breathing or throat tightness o chest tightness o skin rash, hives \u2022 Infections. SOTYKTU is a medicine that affects your immune system. SOTYKTU can lower the ability of your immune system to fight infections and can increase your risk of infections. Some people have had serious infections while taking SOTYKTU, such as infections of the lungs, including pneumonia and tuberculosis (TB), and COVID-19. o Your healthcare provider should check you for infections and TB before starting treatment with SOTYKTU. o Your healthcare provider may treat you for TB before you begin treatment with SOTYKTU if you have a history of TB or have active TB. o Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with SOTYKTU. o I...", "clinical_studies": "14.1 Plaque Psoriasis The efficacy and safety of SOTYKTU were assessed in two multicenter, randomized, double-blind, placebo- and active-controlled clinical trials, Trial PSO-1 (NCT03624127) and Trial PSO-2 (NCT03611751) which enrolled subjects 18 years of age and older with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Subjects had a body surface area (BSA) involvement of \u2265 10%, a Psoriasis Area and Severity Index (PASI) score \u2265 12, and a static Physician\u2019s Global Assessment (sPGA) \u2265 3 (moderate or severe). In Trials PSO-1 and PSO-2, efficacy was assessed in 1,684 subjects randomized to either SOTYKTU (6 mg orally once daily), placebo, or apremilast (30 mg orally twice daily). Endpoints Both trials assessed responses at Week 16 compared to placebo for two co-primary endpoints: \u2022 proportion of subjects who achieved a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; \u2022 the proportion of subjects who achieved at least a 75% improvement in PASI scores from baseline (PASI 75). Other comparisons between SOTYKTU and placebo that were secondary endpoints at Week 16: \u2022 the proportion of subjects who ...", "brand_name": "SOTYKTU", "manufacturer": "E.R. Squibb & Sons, L.L.C.", "application_number": "NDA214958", "pharm_class_epc": [ "Tyrosine Kinase 2 Inhibitor [EPC]" ], "route": [ "ORAL" ], "effective_time": "20260630", "set_id": "ff4d7258-5068-4cdf-9692-8cae04c3198e", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 2800, "serious": 572, "death": 43, "hospitalization": 153, "primary_suspect": 2796, "top_reactions": [ [ "Drug Ineffective", 275 ], [ "Acne", 243 ], [ "Pruritus", 226 ], [ "Rash", 195 ], [ "Psoriasis", 174 ], [ "Erythema", 153 ], [ "Off Label Use", 113 ], [ "Adverse Event", 81 ], [ "Headache", 81 ], [ "Product Dose Omission Issue", 79 ], [ "Skin Burning Sensation", 78 ], [ "Mouth Ulceration", 74 ], [ "Pain", 71 ], [ "Folliculitis", 66 ], [ "Diarrhoea", 58 ] ], "by_year": { "2020": 1, "2021": 1, "2022": 140, "2023": 1052, "2024": 850, "2025": 579, "2026": 177 }, "by_year_primary": { "2020": 1, "2021": 1, "2022": 140, "2023": 1050, "2024": 849, "2025": 578, "2026": 177 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 1, "nda": 1, "anda": 0, "first_approval": "20220909", "rems": false, "rems_last": "", "labeling_supplements": 1, "labeling_recent": 1, "sponsors": [ "BRISTOL" ], "unapproved": false, "first_approval_fmt": "09/09/2022" }, "trials": { "total": 102, "completed": 50, "terminated": 13, "with_results": 26, "industry": 85, "phase3": 21, "results_share": 0.52, "terminated_share": 0.12745098039215685 }, "pubmed": { "rct": 28, "meta": 7, "recent_rct": 28, "cochrane": [] }, "payments": { "year": "2024", "usd": 6405237.71, "records": 87375, "by_name": [ [ "Sotyktu", 6405237.71 ] ], "names_checked": [ "deucravacitinib", "Sotyktu" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 8580, "beneficiaries": 1803, "spend": 62226383.8, "by_brand": [ { "brand": "Sotyktu", "claims": 8580, "per_claim": 7252.4922844, "is_generic": false } ], "per_claim": 7252.492284382284 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "Death share in reports is near or below the FAERS average (0.2x)" ], "weight": 0.35 }, "evidence": { "score": 39, "letter": "F", "why": [ "28 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 85, "letter": "B", "why": [ "No recalls on record since 2016", "Label lists recent major changes to warnings or indications (-5)", "Approved within the last 5 years: long-term safety is not yet known (-10)" ], "weight": 0.15 }, "conflict": { "score": 70, "letter": "C", "why": [ "Pharma paid doctors $6,405,238 tied to this drug last year (-30)", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "No generic version approved: brand-only pricing (-30)", "5 same-class alternatives exist" ], "weight": 0.1 } }, "total": 75, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are acne, pruritus, rash. How would we recognize and handle those?", "Why this one over baricitinib, deuruxolitinib, ritlecitinib? What would make you pick one of those instead?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }