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What Is Renflexis?

Renflexis is a prescription biologic medication containing infliximab-abda, a biosimilar to the reference product Remicade. It is a tumor necrosis factor alpha, or TNF-alpha, inhibitor used to treat selected autoimmune and inflammatory diseases. Renflexis is administered by intravenous infusion and is approved for conditions including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. As an FDA-approved biosimilar, Renflexis is highly similar to Remicade, with no clinically meaningful differences in safety, purity, or potency. It carries boxed warnings for serious infections and malignancies.

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What Is Renflexis?

Renflexis is a prescription biologic medication containing infliximab-abda, a biosimilar to the reference product Remicade. It is a tumor necrosis factor alpha, or TNF-alpha, inhibitor used to treat selected autoimmune and inflammatory diseases. Renflexis is administered by intravenous infusion and is approved for conditions including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. As an FDA-approved biosimilar, Renflexis is highly similar to Remicade, with no clinically meaningful differences in safety, purity, or potency. It carries boxed warnings for serious infections and malignancies.

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How Does Renflexis Work?

Renflexis contains infliximab-abda, a monoclonal antibody that binds to TNF-alpha and blocks its inflammatory activity. TNF-alpha contributes to immune signaling and tissue inflammation in conditions affecting the intestines, joints, and skin. By inhibiting this protein, Renflexis can reduce symptoms and help control inflammatory disease activity. Its mechanism is the same as that of the reference biologic Remicade. Renflexis does not cure the underlying autoimmune condition. Because TNF-alpha also contributes to the body's defenses against certain pathogens, treatment can increase susceptibility to serious infections and reactivate latent tuberculosis.

What Conditions Does Renflexis Treat?

Renflexis is approved for moderately to severely active Crohn's disease and ulcerative colitis in eligible adults and children aged six years and older. It is also approved for moderately to severely active rheumatoid arthritis in adults when used with methotrexate, active ankylosing spondylitis, active psoriatic arthritis, and chronic severe plaque psoriasis in specified adults. These indications correspond to those of its reference product, Remicade. A clinician evaluates disease severity, previous treatments, infection history, and other medications before recommending Renflexis. Screening for tuberculosis and hepatitis B is important before initiating treatment.

How Is Renflexis Administered?

Renflexis is administered intravenously by trained healthcare professionals. For Crohn's disease and ulcerative colitis, the recommended induction dose is commonly 5 mg/kg at weeks zero, two, and six, followed by 5 mg/kg every eight weeks. Rheumatoid arthritis typically uses 3 mg/kg on the same induction schedule, followed by maintenance treatment every eight weeks in combination with methotrexate. Ankylosing spondylitis and other approved conditions have different maintenance intervals. Infusions are administered over at least two hours, and patients are monitored for reactions. Healthcare professionals prepare the medication and assess ongoing treatment response and infection risk.

What Are the Side Effects and Warnings of Renflexis?

Common adverse effects include respiratory infections, headache, nausea, abdominal discomfort, and infusion reactions. Renflexis carries boxed warnings for serious infections and malignancies, including lymphoma. Tuberculosis, invasive fungal infections, and opportunistic infections can occur, particularly in patients taking additional immunosuppressive medications. Rare hepatosplenic T-cell lymphoma has been reported with TNF blockers, including infliximab products. Other serious concerns include hepatitis B reactivation, liver injury, worsening heart failure, blood disorders, and demyelinating conditions. Patients should promptly report fever, persistent cough, unusual swelling, neurological symptoms, or signs of a severe allergic reaction.

Common Questions About Renflexis

Is Renflexis the same as Remicade?

Renflexis contains infliximab-abda and is an FDA-approved biosimilar to Remicade. The products are highly similar but have distinct product names and manufacturing processes.

Can Renflexis treat rheumatoid arthritis?

Yes. Renflexis is approved for moderately to severely active rheumatoid arthritis in adults when prescribed with methotrexate.

Is Renflexis administered by injection or infusion?

Renflexis is administered through an intravenous infusion by healthcare professionals, generally over at least two hours.

Can patients switch from Remicade to Renflexis?

A healthcare professional may consider switching between infliximab products based on clinical circumstances. FDA biosimilar approval does not automatically mean a product has an interchangeability designation for pharmacy-level substitution.

References

Biosimilar Product Information. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Date Accessed November 3, 2026.

DailyMed - RENFLEXIS (infliximab-abda) injection, powder, lyophilized, for solution. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dbf738c4-3fac-4422-a9d8-51d9c83a8789. Date Accessed November 3, 2026.

Infliximab. LiverTox. https://www.ncbi.nlm.nih.gov/books/NBK548203/. Date Accessed November 3, 2026.

Infliximab Injection. MedlinePlus. https://medlineplus.gov/druginfo/meds/a604023.html. Date Accessed November 3, 2026.

Renflexis Product Details. U.S. Food and Drug Administration Purple Book. https://purplebooksearch.fda.gov/index.cfm?blaNo=761054&event=productdetails. Date Accessed November 3, 2026.