INFLECTRA (infliximab-dyyb)
INFLECTRA is indicated for the treatment of Crohn's Disease; Fistulizing Disease; Ulcerative Colitis; Rheumatoid Arthritis.
How INFLECTRA Works
INFLECTRA functions by binding with high affinity to both the soluble and transmembrane forms of tumor necrosis factor alpha (TNFα), a cytokine that plays a key role in inflammatory responses. By binding to TNFα, the drug prevents the cytokine from interacting with its receptors, thereby neutralizing its biological activity. This inhibition leads to a reduction in proinflammatory cytokines, decreased leukocyte migration, and lower levels of tissue-degrading enzymes. Additionally, the drug can cause the lysis of cells that express transmembrane TNFα on their surface.
Details
- Status
- Prescription
- First Approved
- 2016-04-05
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
INFLECTRA Approval History
What INFLECTRA Treats
4 indicationsINFLECTRA is approved for 4 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Crohn's Disease
- Fistulizing Disease
- Ulcerative Colitis
- Rheumatoid Arthritis
INFLECTRA Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY 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 histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) • Discontinue INFLECTRA if a patient develops a serious infection. • Perform test for latent TB; if positive, start treatment f...
WARNING: SERIOUS INFECTIONS and MALIGNANCY 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 histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) • Discontinue INFLECTRA if a patient develops a serious infection. • Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. 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 infliximab products 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. INFLECTRA should be discontinued 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. Patients should be tested for latent tuberculosis before INFLECTRA use and during therapy. Treatme
INFLECTRA 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.
INFLECTRA is a lower-cost alternative to Remicade with no clinically meaningful differences. Requires prescriber approval to substitute.
INFLECTRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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 INFLECTRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INFLECTRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to INFLECTRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
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.
INFLECTRA FDA Label Details
Indications & Usage
FDA Label (PDF)INFLECTRA is indicated for the treatment of Crohn's Disease; Fistulizing Disease; Ulcerative Colitis; Rheumatoid Arthritis.
WARNING: SERIOUS INFECTIONS and MALIGNANCY 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 (suc...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.