Infliximab

What it is and how it works

Mechanism of Action Infliximab neutralizes the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibits binding of TNFα with its receptors. Infliximab does not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Biological activities attributed to TNFα include: induction of pro-inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other …

Mechanism class: Tumor Necrosis Factor Receptor Blocking Activity

Indications

Infliximab 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 severely active disease who have had an inadequate response to conventional therapy. Ulcerative Colitis : reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Dosage and administration (summary)

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion. Infliximab is administered by intravenous infusion for at least 2 hours with an in-line filter Crohn's Disease : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg every 8 weeks if they later lose their response. Pediatric Crohn's Disease (≥ 6 years old) : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Ulcerative Colitis : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Contraindications

The use of Infliximab at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure . Infliximab is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of Infliximab or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] . Infliximab doses >5 mg/kg in moderate or severe heart failure.

Warnings and precautions

Serious infections – do not give Infliximab during an active infection. If an infection develops, monitor carefully and stop Infliximab if infection becomes serious. Invasive fungal infections – for patients who develop a systemic illness on Infliximab, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic Malignancies – the incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in Infliximab treated patients than in controls.

Pregnancy

Pregnancy Risk Summary Available observational studies in pregnant women exposed to Infliximab showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. However, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct (see Data ) .

Storage and supply

Storage and Handling Store unopened Infliximab vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). If needed, unopened Infliximab vials may be stored at room temperatures up to a maximum of 30 °C (86 °F) for a single period of up to 6 months but not exceeding the original expiration date.

Source: Infliximab (Infliximab) — US FDA prescribing information, 2026-02-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.