Last reviewed 2026-04-20 · How we verify

RENFLEXIS (INFLIXIMAB-ABDA)

RENFLEXIS (generic name: INFLIXIMAB-ABDA) is a Tumor Necrosis Factor Blocker [EPC] drug developed by SAMSUNG BIOEPIS CO LTD. It is currently FDA-approved.

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• 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 latent infection should be initiated prior to RENFLEXIS use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with RENFLEXIS should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RENFLEXIS, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products [see Warnings and Precautions (5.2) ] . Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.

Common side effects

• Infusion-related reactions
• Infections (upper respiratory, sinusitis, pharyngitis)
• Headache
• Abdominal pain
• Fever or chills

Serious adverse events

• Serious infusion reactions (anaphylaxis, convulsions, erythematous rash, hypotension)
• Cardiopulmonary reactions (chest pain, hypotension, hypertension, dyspnea)
• Pruritus/urticaria with cardiopulmonary reactions
• Anaphylaxis
• Convulsions

Key clinical trials

• Phase II Study of Infliximab for the Treatment of Immune Checkpoint Inhibitor Colitis (Phase 2)
• A Phase II Study of PD-1 Blockade With or Without LAG-3 Inhibition in Combination With Infliximab for the Treatment of Metastatic Melanoma and Prevention of Adverse Events (Phase 2)
• Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (Phase 4)
• Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease (Phase 2)
• A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19). (Phase 2)
• EPIC - A Phase 2, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) in (Phase 2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• RENFLEXIS CI brief — competitive landscape report
• RENFLEXIS updates RSS · CI watch RSS
• SAMSUNG BIOEPIS CO LTD portfolio CI

Frequently asked questions about RENFLEXIS

Related

• Drug class: All Tumor Necrosis Factor Blocker [EPC] drugs
• Manufacturer: SAMSUNG BIOEPIS CO LTD — full pipeline
• Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing