Infliximab

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.

• REMICADE 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. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.ICD-10: K50.90

• The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] . REMICADE is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ].contraindicated

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion. ( 2.11 ) REMICADE is administered by intravenous infusion for at least 2 hours with an in-line filter ( 2.11 ) 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. ( 2.1 ) Pediatric Crohn's Disease (≥ 6 years old) : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.2 ) Ulcerative Colitis : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.3 ) Pediatric Ulcerative Colitis (≥ 6 years old) : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.4 ) Rheumatoid Arthritis : In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks. ( 2.5 ) Ankylosing Spondylitis : 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. ( 2.6 ) Psoriatic Arthritis and Plaque Psoriasis : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. ( 2.7 , 2.8 ) 2.1 Dosage in Adult Crohn's Disease The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active CD or fistulizing CD.

Serious infections – do not give REMICADE during an active infection. If an infection develops, monitor carefully and stop REMICADE if infection becomes serious. ( 5.1 ) Invasive fungal infections – for patients who develop a systemic illness on REMICADE, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic ( 5.1 ) Malignancies – the incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in REMICADE-treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn's disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment. ( 5.2 ) Hepatitis B virus reactivation – test for HBV infection before starting REMICADE. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop REMICADE and begin anti-viral therapy. ( 5.3 ) Hepatotoxicity – severe hepatic reactions, some fatal or necessitating liver transplantation. Stop REMICADE in cases of jaundice and/or marked liver enzyme elevations. ( 5.4 ) Heart failure – new onset or worsening symptoms may occur. ( 4 , 5.5 ) Cytopenias – advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping REMICADE. ( 5.6 ) Hypersensitivity – serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur.

Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults The data described herein reflect exposure to REMICADE in 4779 adult patients (1304 patients with RA, 1106 patients with CD, 202 with AS, 293 with PsA, 484 with UC, 1373 with Ps, and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year. [For information on adverse reactions in pediatric patients see Adverse Reactions (6.1) ]. One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache and rash). Infusion-Related Reactions Adverse Reactions During or Shortly After Infusion An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 hour after an infusion. In all the clinical studies, approximately 20% of REMICADE-treated patients experienced an infusion reaction compared with 10% of placebo-treated patients.

8.1 Pregnancy Risk Summary Available observational studies in pregnant women exposed to REMICADE 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 ) . Monoclonal antibodies such as infliximab are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see Clinical Considerations ) . Because infliximab does not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with REMICADE. In a developmental study conducted in mice using an analogous antibody, no evidence of maternal toxicity or fetal harm was observed (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Metabolism

In adults, single intravenous (IV) infusions of 3 mg/kg to 20 mg/kg (two times the maximum recommended dose for any indication) showed a linear relationship between the dose administered and the maximum serum concentration. The volume of distribution at steady state was independent of dose and indicated that infliximab was distributed primarily within the vascular compartment.

Single doses up to 20 mg/kg have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects [see Warnings and Precautions (5) ] and appropriate symptomatic treatment instituted immediately.

• Aug 24, 1998BLABLA103772Centocor Inc
• Apr 5, 2016BLABLA125544Celltrion Inc
• Apr 21, 2017BLABLA761054Samsung Bioepis Co Ltd
• Dec 6, 2019BLABLA761086Amgen Inc
• Oct 20, 2023BLABLA761358Celltrion

1. 1Off Label Use51,79722%
2. 2Drug Ineffective42,42418%
3. 3Condition Aggravated28,53512%
4. 4Arthralgia21,5819.0%
5. 5Pain20,3488.5%
6. 6Intentional Product Use Issue19,4408.1%
7. 7Fatigue19,3938.1%
8. 8Infusion Related Reaction19,3758.1%
9. 9Rheumatoid Arthritis18,6027.7%
10. 10Product Use Issue14,3826.0%
11. 11Nausea14,2055.9%
12. 12Rash14,1695.9%
13. 13Inappropriate Schedule Of Product Administration13,2225.5%
14. 14Headache13,1325.5%
15. 15Malaise12,5425.2%

Recent PubMed references pinned to Infliximab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Rare Complications in Crohn's Disease: Diagnostic and Therapeutic Challenge of Dermal Abscesses Caused by Nontuberculous Mycobacteria Following Infliximab Therapy, and Fluoroquinolone-Related Achilles Tendon Rupture.
  The American journal of case reports · 2026 · Gupta N, Yadav K, Carter A, et al.
  PMID 42244158DOI 10.12659/AJCR.952790
• GENERATIVE AI TOWARDS A COMPARATIVE ANALYSIS OF HOSPITALIZATION RATES AMONG PATIENTS WITH ULCERATIVE COLITIS TREATED WITH INFLIXIMAB, VEDOLIZUMAB, AND TOFACITINIB IN THE PUBLIC HEALTHCARE SYSTEM IN BRAZIL: A NATIONWIDE STUDY.
  Arquivos de gastroenterologia · 2026 · Valverde DA, Quaresma AB, Villamil MPG, et al.
  PMID 42207071DOI 10.1590/S0004-2803.24612025-066
• Anti-TNF Drug-Induced Sarcoidosis in Inflammatory Bowel Diseases: Multicentric Case Series and Literature Review.
  BioMed research international · 2026 · Bez P, Chkolnaia Z, Aratari A, et al.
  PMID 42170754DOI 10.1155/bmri/7554982
• Short-term efficacy and safety of infliximab biosimilar (HS626) in inducing remission of inflammatory bowel disease: A real-world single-center study.
  Medicine · 2026 · Huang YS, Lai DP, Nong H, et al.
  PMID 42152434DOI 10.1097/MD.0000000000048853
• [Relationships of interleukin-7 receptor gene polymorphisms with the risk of Crohn's disease and the efficacy of infliximab].
  Zhonghua yi xue za zhi · 2026 · Dai CX, Xu JY, Chen WW, et al.
  PMID 42103677DOI 10.3760/cma.j.cn112137-20251111-02949
• Overcoming the detection limit of GMR sensors using disk-shaped nanostructures.
  Talanta · 2026 · Diez-Martin E, Redondo C, Albuquerque D, et al.
  PMID 42019287DOI 10.1016/j.talanta.2026.129859
• Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials.
  United European gastroenterology journal · 2026 · Colombel JF, Danese S, Schreiber S, et al.
  PMID 41986154DOI 10.1002/ueg2.70205
• Evaluating Random-Access CLIA for Anti-TNF Drug Monitoring: a Comparison with Traditional ELISA.
  Clinical laboratory · 2026 · Ashorov O, Huta Y, Gingold-Belfer R, et al.
  PMID 41979611DOI 10.7754/Clin.Lab.2025.250948

The 10 most recently updated of 621 ClinicalTrials.gov registrations naming Infliximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease
  Recruiting · Observational · 40 enrolled · Shmuel Kivity, MD
  NCT07644117updated 2026-06-12
• Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms
  Recruiting · Phase 1 · Phase 2 · Interventional · 8 enrolled · University of California, San Francisco
  NCT02638701updated 2026-06-11
• TNF-α Antagonists Mitigate Systemic Inflammatory Response After Cardiac Arrest.
  Active not recruiting · Interventional · 208 enrolled · Peking University Third Hospital
  NCT07176754updated 2026-06-10
• TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
  Recruiting · Phase 4 · Interventional · 312 enrolled · Sixth Affiliated Hospital, Sun Yat-sen University
  NCT07510191updated 2026-06-09
• A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
  Active not recruiting · Phase 3 · Interventional · 84 enrolled · Janssen Research & Development, LLC
  NCT03596645updated 2026-06-08
• Psoriasis Longitudinal Assessment and Registry
  Active not recruiting · Observational · 15,849 enrolled · Janssen Scientific Affairs, LLC
  NCT00508547updated 2026-06-05
• A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
  Active not recruiting · Observational · 4,970 enrolled · Janssen Biotech, Inc.
  NCT00606346updated 2026-06-05
• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease
  Active not recruiting · Phase 2 · Interventional · 26 enrolled · Hawaii Pacific Health
  NCT01917721updated 2026-06-03
• Anti-Inflammatory Challenge in Schizophrenia
  Recruiting · Phase 4 · Interventional · 60 enrolled · Emory University
  NCT05823532updated 2026-06-03

CPIC-curated drug–gene pairs for Infliximab. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• TNFCPIC C (provisional)ClinPGx 3

Frequently asked questions

How does Infliximab work?

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.

What is Infliximab used for?

According to FDA labeling, Infliximab carries indications including: REMICADE 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. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Infliximab?

Infliximab is classified as Tumor necrosis factor alpha (TNF-alpha) inhibitors, Tumor Necrosis Factor Blocker, Biological Response Modifiers, Tumor Necrosis Factor alpha Receptor Blocking Activity, Tumor Necrosis Factor Receptor Blocking Activity, Decreased Vascular Permeability, Increased Adhesion Factor Production.

What are the brand names for Infliximab?

Infliximab is marketed under brand names including Avsola, Inflectra, Remicade, Renflexis, Zymfentra.

What are the contraindications for Infliximab?

Infliximab labeling lists contraindications including: The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] . REMICADE is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ].. Always consult the full prescribing information and a clinician.