{ "query": "bimekizumab", "ingredient": "bimekizumab", "slug": "bimekizumab", "rxcui": "2668041", "brands": [], "names": [ "bimekizumab" ], "classes": [ { "id": "L04AC", "name": "Interleukin inhibitors" } ], "alternatives": [ "anakinra", "basiliximab", "brodalumab", "canakinumab", "daclizumab", "guselkumab", "ixekizumab", "mirikizumab", "rilonacept", "risankizumab", "sarilumab", "satralizumab", "secukinumab", "siltuximab", "spesolimab", "tildrakizumab", "tocilizumab", "ustekinumab" ], "label": { "route_mode": "SUBCUTANEOUS", "route_counts": { "SUBCUTANEOUS": 1 }, "boxed_warning": "", "indications_and_usage": "is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Adults with active psoriatic arthritis (PsA) . ( 1.2 ) Adults with active non-radiographic axial spondyloarthritis ( nr-axSpA ) with objective signs of inflammation. ( 1.3 ) Adults with active ankylosing spondylitis ( AS ). ( 1.4 ) Adults with moderate to severe hidradenitis suppurativa (HS) . ( 1.5 ) 1.1 Plaque Psoriasis BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis BIMZELX is indicated for the treatment of adults with active psoriatic arthritis. 1.3 Non-Radiographic Axial Spondyloarthritis BIMZELX is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. 1.4 Ankylosing Spondylitis BIMZELX is indicated for the treatment of adults with active ankylosing spondylitis. 1.5 Hidradenitis Suppurativa BIMZELX is indicated for the treatment of adults with moderate to severe hidradenitis suppurativa.", "contraindications": "None. None. ( 4 )", "warnings_and_cautions": "Suicidal Ideation and Behavior (SI/B) : May increase risk of SI/B. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior. ( 5.1 ) Infections : May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer BIMZELX until the infection resolves. ( 5.2 ) Tuberculosis (TB) : Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment. ( 5.3 ) Liver Biochemical Abnormalities : Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally - associated combined elevations of transaminases and ...", "warnings": "", "adverse_reactions": "The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling: Suicidal Ideation and Behavior [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Liver Biochemical Abnormalities [see Warnings and Precautions (5.4) ] Inflammatory Bowel Disease [see Warnings and Precautions (5.5) ] Most common adverse reactions are: Psoriasis and Hidradenitis Suppurativa (incidence \u2265 1%): upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. ( 6.1 ) Psoriatic Arthritis (incidence \u2265 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection. ( 6.1 ) Non-Radiographic Axial Spondyloarthritis (incidence \u2265 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsilitis, transaminase increase, and urinary tract infection. ( 6.1 ) Ankylosing Spondylitis (incidence \u2265 2%): upper respiratory tract infections, oral candidiasis, heada...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Indications and Usage ( 1.2 , 1.3 , 1.4 , 1.5 ) 11/2024 Dosage and Administration ( 2.3 , 2.4 , 2.5 , 2.6 , 2.7 ) 11/2024 Warnings and Precautions ( 5.1 , 5.2 ) 11/2024", "information_for_patients": "Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration Instructions Instruct patients or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique [see Dosage and Administration (2.9) , Instructions for Use]. If two separate 160 mg injections are used to achieve the recommended dose, instruct patients or caregivers to administer each injection subcutaneously at a different anatomic location [see Dosage and Administration (2.9) ] . Instruct patients or caregivers in the technique of needle and syringe disposal [see Instructions for Use] . Advise patients if they forget to take their dose of BIMZELX to inject their dose as soon as they remember. Instruct patients to then take their next dose at the appropriate scheduled time [see Dosage and Administration (2.7 )] . Suicidal Ideation and Behavior Instruct patients and their caregivers to monitor for the emergence of suicidal ideation and behavior and promptly seek medical attention if the patient experiences suicidal ideation or behavio...", "spl_medguide": "MEDICATION GUIDE BIMZELX \u00ae (bim zel'ex) (bimekizumab-bkzx) injection, for subcutaneous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: November 2024 What is the most important information I should know about BIMZELX? BIMZELX is a medicine that affects your immune system. BIMZELX may increase your risk of having serious side effects, including: Suicidal thoughts and behavior. New or worsening suicidal thoughts and behavior have happened in some people treated with BIMZELX. Get medical help right away or call the National Suicide and Crisis Lifeline at 988 if you, your caregiver or your family member notice in you any of the following symptoms: new or worsening depression or anxiety thoughts of suicide, dying, or hurting yourself changes in behavior or mood acting on dangerous impulses attempt to commit suicide Infections . BIMZELX is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections, including serious infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with BIMZELX. If your healthcare provider feels you...", "clinical_studies": "14.1 Plaque Psoriasis Three multicenter, randomized, double-blind trials [Trial Ps-1 (NCT03370133), Trial Ps-2 (NCT03410992), and Trial Ps-3 (NCT03412747)] enrolled a total of 1,480 subjects 18 years of age and older with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of \u226510%, an Investigator's Global Assessment (IGA) score of \u22653 (\"moderate\") in the overall assessment of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score \u226512. In Trial Ps-1, 567 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks, ustekinumab (for subjects weighing \u2264100kg, 45 mg initially and 4 weeks later, then every 12 weeks; for subjects weighing >100kg, 90 mg initially and 4 weeks later, then every 12 weeks), or placebo through Week 52. At Week 16, subjects originally randomized to placebo received BIMZELX 320 mg every 4 weeks through Week 52. In Trial Ps-2, 435 subjects were randomized to either BIMZELX 320 mg by subcutaneous injection every 4 weeks or placebo. At Week 16, subjects who achieved a PASI 90 response continued into a 40-week randomized withdrawal period. Subjects originally ra...", "brand_name": "Bimzelx", "manufacturer": "UCB, Inc.", "application_number": "BLA761151", "pharm_class_epc": [], "route": [ "SUBCUTANEOUS" ], "effective_time": "20250616", "set_id": "26b88358-871f-4c80-9d80-b2fb16477f81", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 4038, "serious": 3856, "death": 57, "hospitalization": 1014, "primary_suspect": 4033, "top_reactions": [ [ "Psoriatic Arthropathy", 970 ], [ "Psoriasis", 617 ], [ "Drug Ineffective", 483 ], [ "Injection Site Pain", 397 ], [ "Inappropriate Schedule Of Product Administration", 361 ], [ "Off Label Use", 287 ], [ "Product Dose Omission Issue", 285 ], [ "Therapy Interrupted", 282 ], [ "Hidradenitis", 245 ], [ "Fatigue", 221 ], [ "Oral Candidiasis", 218 ], [ "Condition Aggravated", 208 ], [ "Pneumonia", 198 ], [ "Incorrect Dose Administered", 188 ], [ "Therapeutic Response Shortened", 175 ] ], "by_year": { "2019": 1, "2020": 2, "2021": 2, "2022": 9, "2023": 89, "2024": 877, "2025": 2107, "2026": 947 }, "by_year_primary": { "2019": 1, "2020": 2, "2021": 2, "2022": 9, "2023": 88, "2024": 876, "2025": 2104, "2026": 947 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 0, "nda": 0, "anda": 0, "first_approval": "", "rems": false, "rems_last": "", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [], "unapproved": false, "first_approval_fmt": "" }, "trials": { "total": 62, "completed": 39, "terminated": 2, "with_results": 28, "industry": 50, "phase3": 25, "results_share": 0.717948717948718, "terminated_share": 0.03225806451612903 }, "pubmed": { "rct": 48, "meta": 12, "recent_rct": 41, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "bimekizumab" ], "source": "bulk-index" }, "partd": null, "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": 51, "letter": "D", "why": [ "48 randomized trials and 12 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 95, "letter": "A", "why": [ "No recalls on record since 2016", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "No generic version approved: brand-only pricing (-30)", "18 same-class alternatives exist" ], "weight": 0.1 } }, "total": 84, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are psoriatic arthropathy, psoriasis, injection site pain. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over anakinra, basiliximab, brodalumab? 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?", "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.)" ] }