DailyMed
Cure8 regulatory brief
DailyMed label update for STELARA
Medications
Ustekinumab
IL-12/23 inhibitor
Regulatory Update
Adult patients
Pediatric Patients
Clinicians
Crohn's disease
Why This Matters
This label update affects people with Crohn’s disease or ulcerative colitis because it spells out approved uses, age ranges, and the official dosing schedules and safety warnings for ustekinumab (STELARA). Changes in the label can affect how the drug is prescribed and monitored.
Who Should Pay Attention
Adult and pediatric patients with Crohn’s disease or ulcerative colitis, caregivers, and clinicians who prescribe or manage biologic therapy.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Source depthMetadata only
What To Know
This is a DailyMed drug label update for STELARA (ustekinumab) with revised indications, dosing, and warnings.
The label lists approved uses including moderately to severely active Crohn’s disease (adults and pediatric patients 2 years and older) and ulcerative colitis (adult patients), detailed weight‑based IV induction and subcutaneous maintenance dosing schedules for Crohn’s disease and ulcerative colitis, and updated warnings and precautions (infections, TB evaluation, malignancy risk, and hypersensitivity).
The update is a regulatory drug‑label record (DailyMed) and appears to reflect official prescribing information and recent major changes noted in the highlights. It is focused on dosing across indications and age groups, contraindications, and safety warnings rather than new clinical trial results.
Patients should consult their prescribing clinician or the patient version of the label for specific guidance on dosing, administration, and safety monitoring; this curation does not replace medical advice.
Keep In Mind
This is an official DailyMed/drug‑label update (regulatory record). It summarizes prescribing information and safety language rather than reporting new trial results. For practical questions about eligibility, dosing, monitoring, or insurance coverage, contact your clinician or pharmacist.
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
PublishedJul 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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