{
 "query": "infliximab",
 "ingredient": "infliximab",
 "slug": "infliximab",
 "rxcui": "191831",
 "brands": [
  "Remicade"
 ],
 "names": [
  "infliximab"
 ],
 "classes": [
  {
   "id": "L04AB",
   "name": "Tumor necrosis factor alpha (TNF-alpha) inhibitors"
  }
 ],
 "alternatives": [
  "adalimumab",
  "certolizumab pegol",
  "etanercept",
  "golimumab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 5
  },
  "boxed_warning": "WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning \u2022 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 ) \u2022 Discontinue INFLECTRA if a patient develops a serious infection. \u2022 Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) \u2022 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 ) \u2022 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 co...",
  "indications_and_usage": "is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease ( 1.1 ): \u2022 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. \u2022 reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. Pediatric Crohn's Disease ( 1.2 ): \u2022 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 ( 1.3 ): \u2022 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. Pediatric Ulcerative Colitis ( 1.4 ): \u2022 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 ...",
  "contraindications": "The use of INFLECTRA 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) ]. INFLECTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of INFLECTRA 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) ]. \u2022 INFLECTRA doses >5 mg/kg in moderate or severe heart failure. ( 4 ) \u2022 Previous severe hypersensitivity reaction to infliximab products or any inactive ingredients of INFLECTRA or to any murine proteins. ( 4 )",
  "warnings_and_cautions": "\u2022 Serious infections \u2013 do not give INFLECTRA during an active infection. If an infection develops, monitor carefully and stop INFLECTRA if infection becomes serious. ( 5.1 ) \u2022 Invasive fungal infections \u2013 for patients who develop a systemic illness on INFLECTRA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. ( 5.1 ) \u2022 Malignancies \u2013 the incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in infliximab-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 ) \u2022 Hepatitis B virus (HBV) reactivation \u2013 test for HBV infection before starting INFLECTRA. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop INFLECTRA and begin anti-viral therapy. ( 5.3 ) \u2022 Hepatotoxicity \u2013 severe hepatic reactions, some fatal or necessitating liver transplantation. Stop INFLECTRA in cases of jaundice and/or marked liver enzyme elevations. ( 5.4 ) \u2022 Heart failure \u2013new onset or worsening symptoms ma...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions (>10%) \u2013 infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION, Inc. at 1-800-383-7504 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 infliximab 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 Reacti...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient or their caregiver to read the FDA-Approved Patient Labeling (Medication Guide). Patients or their caregivers should be advised of the potential benefits and risks of INFLECTRA. Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting INFLECTRA therapy and to reread it each time they receive an infusion. Infections Inform patients that INFLECTRA increases the risk for developing serious infections. Instruct patients of the importance of contacting their healthcare provider if they develop any symptoms of an infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions (5.1 , 5.3) ]. Malignancies Malignancies have been reported among children, adolescents and young adults who received treatment with TNF blockers. Patients should be counseled about the risk of lymphoma and other malignancies while receiving INFLECTRA [see Warnings and Precautions (5.2) ]. Hepatotoxicity Instruct patients to seek medical attention if they develop signs or symptoms of hepatotoxicity (e.g., jaundice) [see Warnings and Precautions (5.4) ]. Heart Fa...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: September 2025 MEDICATION GUIDE INFLECTRA \u00ae (In-flec-tra) (infliximab-dyyb) for injection, for intravenous use Read the Medication Guide that comes with INFLECTRA before you receive the first treatment, and before each time you get a treatment of INFLECTRA. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about INFLECTRA? INFLECTRA may cause serious side effects, including: 1. Risk of infection INFLECTRA is a medicine that affects your immune system. INFLECTRA can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving INFLECTRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. \u2022 Your doctor should test you for TB before starting INFLECTRA. \u2022 Your doctor should monitor you closely for signs and symptoms of TB during treatment with INFLECTRA. Before starting INFLECTRA, tell your doctor i...",
  "clinical_studies": "14.1 Adult Crohn's Disease Active Crohn's Disease in Adults The safety and efficacy of single and multiple doses of infliximab were assessed in 2 randomized, double-blind, placebo-controlled clinical studies in 653 adult patients with moderate to severely active CD [Crohn's Disease Activity Index (CDAI) \u2265220 and \u2264400] with an inadequate response to prior conventional therapies. Concomitant stable doses of aminosalicylates, corticosteroids and/or immunomodulatory agents were permitted and 92% of patients continued to receive at least one of these medications. In the single-dose trial of 108 adult patients, 16% (4/25) of placebo patients achieved a clinical response (decrease in CDAI \u226570 points) at Week 4 vs. 81% (22/27) of patients receiving 5 mg/kg infliximab (P<0.001, two-sided, Fisher's Exact test). Additionally, 4% (1/25) of placebo patients and 48% (13/27) of patients receiving 5 mg/kg of infliximab achieved clinical remission (CDAI<150) at Week 4. In a multidose trial (ACCENT I [Study Crohn's I]), 545 adult patients received 5 mg/kg at Week 0 and were then randomized to one of three treatment groups; the placebo maintenance group received placebo at Weeks 2 and 6, and then eve...",
  "brand_name": "INFLECTRA",
  "manufacturer": "Pfizer Laboratories Div Pfizer Inc",
  "application_number": "BLA125544",
  "pharm_class_epc": [
   "Tumor Necrosis Factor Blocker [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260728",
  "set_id": "37eaca10-d812-48bc-8b8e-b836bfa9968f",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 162622,
  "serious": 139270,
  "death": 9621,
  "hospitalization": 43320,
  "primary_suspect": 162569,
  "top_reactions": [
   [
    "Off Label Use",
    40034
   ],
   [
    "Drug Ineffective",
    38351
   ],
   [
    "Condition Aggravated",
    19963
   ],
   [
    "Rheumatoid Arthritis",
    17903
   ],
   [
    "Pain",
    17431
   ],
   [
    "Arthralgia",
    16183
   ],
   [
    "Fatigue",
    15750
   ],
   [
    "Infusion Related Reaction",
    14167
   ],
   [
    "Product Use Issue",
    13792
   ],
   [
    "Intentional Product Use Issue",
    13440
   ],
   [
    "Drug Intolerance",
    12522
   ],
   [
    "Rash",
    12263
   ],
   [
    "Alopecia",
    11519
   ],
   [
    "Joint Swelling",
    11217
   ],
   [
    "Nausea",
    10729
   ]
  ],
  "by_year": {
   "2019": 14994,
   "2020": 19781,
   "2021": 14591,
   "2022": 18655,
   "2023": 14181,
   "2024": 12377,
   "2025": 12108,
   "2026": 4294
  },
  "by_year_primary": {
   "2019": 14993,
   "2020": 19781,
   "2021": 14589,
   "2022": 18650,
   "2023": 14169,
   "2024": 12354,
   "2025": 12099,
   "2026": 4293
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "19980824",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "CENTOCOR INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/24/1998"
 },
 "trials": {
  "total": 628,
  "completed": 339,
  "terminated": 83,
  "with_results": 143,
  "industry": 267,
  "phase3": 126,
  "results_share": 0.4218289085545723,
  "terminated_share": 0.1321656050955414
 },
 "pubmed": {
  "rct": 390,
  "meta": 137,
  "recent_rct": 64,
  "cochrane": [
   {
    "pmid": "38372447",
    "title": "Infliximab for maintenance of medically-induced remission in Crohn's disease",
    "year": "2024"
   },
   {
    "pmid": "37982428",
    "title": "Infliximab for medical induction of remission in Crohn's disease",
    "year": "2023"
   },
   {
    "pmid": "12137712",
    "title": "Infliximab for the treatment of rheumatoid arthritis",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 16192.17,
  "records": 49,
  "by_name": [
   [
    "Remicade",
    16192.17
   ]
  ],
  "names_checked": [
   "infliximab",
   "Remicade"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 19002,
  "beneficiaries": 3580,
  "spend": 122409873.92,
  "by_brand": [
   {
    "brand": "Remicade",
    "claims": 17640,
    "per_claim": 6734.6098146,
    "is_generic": false
   },
   {
    "brand": "Infliximab",
    "claims": 1362,
    "per_claim": 2651.5101248,
    "is_generic": true
   }
  ],
  "per_claim": 6441.946843490159
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "infliximab",
  "matched": "infliximab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 79,
   "letter": "B",
   "why": [
    "390 randomized trials and 137 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "Only 42% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $16,192 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are condition aggravated, rheumatoid arthritis. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over adalimumab, certolizumab pegol, etanercept? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}