ZYMFENTRA (infliximab-dyyb)
ZYMFENTRA (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker indicated for the maintenance treatment of adults with moderately to severely active ulcerative colitis or Crohn’s disease. The medication is specifically used in patients who have previously received treatment with an intravenous infliximab product. It serves as a therapeutic option for the ongoing management of these chronic inflammatory bowel conditions following initial intravenous therapy.
How ZYMFENTRA Works
Infliximab-dyyb functions by binding with high affinity to both the soluble and transmembrane forms of tumor necrosis factor alpha (TNFα). This binding action neutralizes the biological activity of TNFα and prevents it from interacting with its cellular receptors. By inhibiting these interactions, the drug blocks the inflammatory signaling pathways associated with TNFα.
Details
- Status
- Prescription
- First Approved
- 2023-10-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZYMFENTRA Approval History
What ZYMFENTRA Treats
2 indicationsZYMFENTRA is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
- Crohn's Disease
ZYMFENTRA Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to ohter opportunistic pathogens. (5.1) Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. (5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ZYMFENTRA. M...
WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to ohter opportunistic pathogens. (5.1) Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. (5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ZYMFENTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. (5.2 ) SERIOUS INFECTIONS Patients treated with TNF blockers, inculding ZYMFENTRA, are at increased risk for developing serious infections that may lead to hospitalization or death [ see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patientsfor latent tuberculosis before ZYMFENTRA use and during therapy. Initiate treatment for latent infection prior to ZYMFENTRA u
ZYMFENTRA Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
ZYMFENTRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZYMFENTRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZYMFENTRA treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYMFENTRA FDA Label Details
Indications & Usage
FDA Label (PDF)ZYMFENTRA is indicated for the treatment of Ulcerative Colitis; Crohn's Disease.
WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to oht...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.