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Cure8 regulatory brief
ZYMFENTRA FDA label update (2026-08-18)
Medications
Infliximab
Anti-TNF
Regulatory Update
Adult patients
Clinicians
Patients On Biologics
Crohn's disease
Why This Matters
The FDA label clarifies that ZYMFENTRA (a TNF blocker) is indicated for maintenance treatment of moderate–severe Crohn’s disease and ulcerative colitis after prior infliximab, and it carries strong safety warnings (serious infections, malignancy, HBV reactivation, hepatotoxicity) that affect monitoring and decisions about use.
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis previously treated with infliximab; clinicians who prescribe or monitor biologic/TNF therapies; caregivers of patients on immunosuppressants.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is an FDA drug label update (ZYMFENTRA) for a tumor necrosis factor (TNF) blocker.
The label lists indications for maintenance treatment of moderately to severely active ulcerative colitis and Crohn’s disease following prior treatment with an infliximab product, and includes a boxed warning about increased risk of serious infections and malignancy, plus specific warnings (TB testing, HBV reactivation, hepatotoxicity, etc.).
The label emphasizes testing for latent tuberculosis before starting therapy, monitoring for infections and liver injury during treatment, and stopping ZYMFENTRA if serious infection, sepsis, or HBV reactivation occurs.
Keep In Mind
This is a regulatory drug-label document (full prescribing information) from DailyMed/ FDA; it reports approved indications and boxed warnings rather than study data. Follow-up and monitoring recommendations reflect label instructions; discuss individual risks with your clinician.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationopenFDA
PublisherU.S. Food and Drug Administration
SponsorCELLTRION USA Inc.
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedAug 18, 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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