openFDA
Cure8 regulatory brief
Why This Matters
An FDA label update names risankizumab (SKYRIZI) as a treatment option for adults with moderately to severely active Crohn’s disease and ulcerative colitis and highlights new or emphasized safety monitoring (liver tests, TB screening, and vaccine guidance).
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis, clinicians prescribing biologic therapies for IBD, and caregivers involved in medication monitoring.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This official label change confirms risankizumab (SKYRIZI) is indicated for adults with moderately to severely active Crohn’s disease and ulcerative colitis.
The label highlights important safety steps: evaluate for tuberculosis before starting treatment, avoid live vaccines during therapy, and check liver enzymes and bilirubin at baseline and during induction (up to at least 12 weeks) because cases of drug‑induced liver injury have been reported.
The dosing and monitoring sections direct clinicians to perform baseline liver tests and to monitor during induction; vaccination status should be updated per guidelines before initiating therapy.
Discuss any safety questions or monitoring plans with your prescribing clinician; this label update is a regulatory document intended to guide clinicians and patients and does not replace individualized medical advice.
Keep In Mind
This is the official FDA/DailyMed drug label (regulatory record). The label focuses on indications and safety monitoring; it is not a clinical trial report and does not present comparative effectiveness data. Patients should consult their prescriber for how the label applies to their situation.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationopenFDA
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedJun 26, 2026, 12:00 AM
Content availableRegulatory record
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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