DailyMed
Cure8 regulatory brief
Why This Matters
The updated official label affects dosing options, monitoring, and safety information for guselkumab in people with Crohn’s disease and ulcerative colitis, which can influence treatment decisions and routine testing.
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis, patients considering or on biologic therapy, gastroenterologists and IBD clinicians, and clinicians managing immunosuppression and vaccine planning.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Source depthMetadata only
What To Know
The label lists guselkumab (an IL‑23 antagonist) as approved for adults with moderately to severely active Crohn’s disease and ulcerative colitis and provides induction and maintenance dosing options (IV and subcutaneous regimens) specific to IBD.
The label highlights safety monitoring for liver tests (baseline and periodic monitoring for IBD indications), tuberculosis evaluation before starting treatment, infection risk, avoidance of live vaccines, and reported adverse reactions for the approved indications.
Clinicians and patients should follow the full prescribing information for details on dosing, contraindications, and management of adverse events; this DailyMed page is the official FDA‑linked label update.
Keep In Mind
This is an official DailyMed drug‑label update (regulatory record). It summarizes approved indications, dosing regimens, and required monitoring; it is not a clinical trial report and does not present new efficacy data. Consult the full prescribing information and your clinician for individualized medical decisions.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationDailyMed
Study typeDrug Label Update
Indexed viaDailyMed
Source typeDrug label record
PublishedOct 23, 2026, 12:00 AM
Content availableMetadata only
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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