RENFLEXIS
RENFLEXIS (infliximab-abda) is a tumor necrosis factor (TNF) blocker used to treat several chronic inflammatory and autoimmune conditions in adult and pediatric patients. It is primarily indicated for patients with moderately to severely active Crohn’s disease or ulcerative colitis who have had an inadequate response to conventional therapy. The drug is also used to manage rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. Its therapeutic role includes reducing signs and symptoms, inducing clinical remission, and inhibiting the progression of structural damage in specific inflammatory diseases.
How RENFLEXIS Works
RENFLEXIS functions by binding with high affinity to both the soluble and transmembrane forms of tumor necrosis factor alpha (TNFα). This binding neutralizes the biological activity of TNFα and prevents it from interacting with its receptors, though it does not neutralize the related cytokine TNFβ. By inhibiting TNFα, the drug suppresses pro-inflammatory processes such as the induction of interleukins, leukocyte migration, and the activation of neutrophils and eosinophils. Additionally, the drug can cause the lysis of cells that express transmembrane TNFα on their surface.
Details
- Status
- Prescription
- First Approved
- 2017-04-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
RENFLEXIS Approval History
What RENFLEXIS Treats
4 indicationsRENFLEXIS is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Crohn's Disease
- Fistula
- Ulcerative Colitis
- Rheumatoid Arthritis
RENFLEXIS 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 RENFLEXIS if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB...
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 RENFLEXIS if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting RENFLEXIS. 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) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. RENFLEXIS 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 RENFLEXIS use and during therapy. Treatment for l
RENFLEXIS 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.
RENFLEXIS is a lower-cost alternative to Remicade with no clinically meaningful differences. Requires prescriber approval to substitute.
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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.
RENFLEXIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)RENFLEXIS is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to ...
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.