DailyMed
Cure8 regulatory brief
DailyMed label update for RENFLEXIS
Medications
Infliximab
Anti-TNF
Biosimilars
Regulatory Update
Adult patients
Pediatric Patients
Clinicians
Why This Matters
Label changes for RENFLEXIS affect people with Crohn's disease or ulcerative colitis who take (or may be prescribed) infliximab biosimilars — the label includes dosing, age indications, and important safety warnings that can influence treatment decisions.
Who Should Pay Attention
Adults and pediatric patients (≥6 years) with Crohn's disease or ulcerative colitis, caregivers, clinicians who prescribe biologics, and patients currently on or considering infliximab biosimilars.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Source depthMetadata only
What To Know
This is a DailyMed prescribing information (label) update for RENFLEXIS (infliximab-abda), an infliximab biosimilar.
The label lists indications, dosing (including Crohn's disease and ulcerative colitis in adults and children ≥6 years), boxed warnings about serious infections and malignancy (including HSTCL risk when combined with azathioprine/6‑mercaptopurine), and administration details for IV infusion.
The summary is grounded in the label highlights provided on DailyMed.
Keep In Mind
This record is a regulatory drug-label (DailyMed) entry summarizing approved indications, dosing, and boxed warnings. It is not a clinical study or new trial result; use the full prescribing information and discuss with your clinician for individual 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
PublishedSep 1, 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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