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LABELS · 36afec96-dd29-9328-e063-6294a90af8e4

REMICADE

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-06-03
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. 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 REMICADE if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. 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 REMICADE. ( 5.2 ) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of REMICADE 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 REMICADE 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. REMICADE 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 REMICADE use and during therapy. Treatment for latent infection should be initiated prior to REMICADE 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 REMICADE 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 REMICADE, 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 REMICADE [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 REMICADE. 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 REMICADE cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE 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. ( 1.1 ) 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. ( 1.2 ) 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. ( 1.3 ) Pediatric Ulcerative Colitis : 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. ( 1.4 ) Rheumatoid Arthritis in combination with methotrexate : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. ( 1.5 ) Ankylosing Spondylitis : reducing signs and symptoms in adult patients with active disease. ( 1.6 ) Psoriatic Arthritis : reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients. ( 1.7 ) Plaque Psoriasis : treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. ( 1.8 ) 1.1 Crohn's Disease REMICADE is indicated for: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) 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 CD. 1.2 Pediatric Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. 1.3 Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. 1.4 Pediatric Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy. 1.5 Rheumatoid Arthritis REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). 1.6 Ankylosing Spondylitis REMICADE is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). 1.7 Psoriatic Arthritis REMICADE is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA). 1.8 Plaque Psoriasis REMICADE is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5) ] .
Full extracted label fields
application numbers
  1. BLA103772
boxed warning exact
  1. 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 REMICADE if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. 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 REMICADE. ( 5.2 ) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of REMICADE 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 REMICADE 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. REMICADE 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 REMICADE use and during therapy. Treatment for latent infection should be initiated prior to REMICADE 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 REMICADE 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 REMICADE, 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 REMICADE [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 REMICADE. 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 REMICADE cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.
brand names
  1. REMICADE
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257
generic names
  1. INFLIXIMAB
id
36afec96-dd29-9328-e063-6294a90af8e4
indications and usage exact
  1. 1 INDICATIONS AND USAGE 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. ( 1.1 ) 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. ( 1.2 ) 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. ( 1.3 ) Pediatric Ulcerative Colitis : 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. ( 1.4 ) Rheumatoid Arthritis in combination with methotrexate : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. ( 1.5 ) Ankylosing Spondylitis : reducing signs and symptoms in adult patients with active disease. ( 1.6 ) Psoriatic Arthritis : reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients. ( 1.7 ) Plaque Psoriasis : treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. ( 1.8 ) 1.1 Crohn's Disease REMICADE is indicated for: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) 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 CD. 1.2 Pediatric Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. 1.3 Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. 1.4 Pediatric Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy. 1.5 Rheumatoid Arthritis REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). 1.6 Ankylosing Spondylitis REMICADE is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). 1.7 Psoriatic Arthritis REMICADE is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA). 1.8 Plaque Psoriasis REMICADE is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5) ] .
indications and usage tables exact
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        payload
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          Application Docs Date
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          Application Docs ID
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          INFLIXIMAB
          Appl No
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          Drug Name
          REMICADE
          Form
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          Product No
          001
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          0
          Reference Standard
          Strength
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          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

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      1 INDICATIONS AND USAGE 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. ( 1.1 ) Pediatric Crohn's Disease : reduc
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                                                            dult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. ( 1.8 ) 1.1 Crohn's Disease REMICADE is indicated for: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) 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 CD. 1.2 Pediatric Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to s
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                                                                1.1 Crohn's Disease REMICADE is indicated for: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) 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 CD.
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                                                                ve 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 CD. 1.2 Pediatric Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. 1.3 Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients wit
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                                                                    ptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. 1.3 Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. 1.4 Pediatric Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately t
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                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%2236afec96-dd29-9328-e063-6294a90af8e4%22
                                                                                            spl effective date
                                                                                            2025-06-03
                                                                                            spl set id
                                                                                            a0a046c1-056d-45a9-bfd9-13b47c24f257
                                                                                            spl version
                                                                                            37
                                                                                            structured fields status
                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                            structured indication
                                                                                            age
                                                                                            Source null
                                                                                            approval pathway
                                                                                            Source null
                                                                                            biomarker and test
                                                                                            Source null
                                                                                            disease stage
                                                                                            Source null
                                                                                            limitations
                                                                                            Source null
                                                                                            line
                                                                                            Source null
                                                                                            prior therapy
                                                                                            Source null
                                                                                            regimen
                                                                                            Source null
                                                                                            tumor histology
                                                                                            Source null
                                                                                            use intent
                                                                                            non_oncology_or_unclear_candidate
                                                                                            Passage 21 · risk or warning
                                                                                            application numbers
                                                                                            1. BLA103772
                                                                                            brand names
                                                                                            1. REMICADE
                                                                                            classification reasons
                                                                                            1. risk_or_warning_words_without_positive_predicate
                                                                                            clinical review status
                                                                                            pending
                                                                                            content role
                                                                                            risk_or_warning
                                                                                            context span
                                                                                            end
                                                                                            4399
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            f adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5) ] .
                                                                                            label id
                                                                                            36afec96-dd29-9328-e063-6294a90af8e4
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            4f6b31e34f772c3e1a5aca0dc370aea2ff504418fbfb443d2ba54ca5259a6539
                                                                                            start
                                                                                            4014
                                                                                            current approval status
                                                                                            not_reconciled
                                                                                            duplicate text group
                                                                                            dup-ff9885179c0f142a806b
                                                                                            extraction review status
                                                                                            automated_candidate_pending_source_review
                                                                                            generic names
                                                                                            1. INFLIXIMAB
                                                                                            id
                                                                                            ind-span-84f47cfb1b9183e8587a
                                                                                            label id
                                                                                            36afec96-dd29-9328-e063-6294a90af8e4
                                                                                            positive predicate support span
                                                                                            Source null
                                                                                            qualifier mentions
                                                                                              regulatory links
                                                                                                schema version
                                                                                                0.1.0
                                                                                                source batch sha256
                                                                                                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                                                                                source defined aliases
                                                                                                  source span
                                                                                                  end
                                                                                                  4399
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5) ] .
                                                                                                  label id
                                                                                                  36afec96-dd29-9328-e063-6294a90af8e4
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  4f6b31e34f772c3e1a5aca0dc370aea2ff504418fbfb443d2ba54ca5259a6539
                                                                                                  start
                                                                                                  4214
                                                                                                  source url
                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%2236afec96-dd29-9328-e063-6294a90af8e4%22
                                                                                                  spl effective date
                                                                                                  2025-06-03
                                                                                                  spl set id
                                                                                                  a0a046c1-056d-45a9-bfd9-13b47c24f257
                                                                                                  spl version
                                                                                                  37
                                                                                                  structured fields status
                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                  structured indication
                                                                                                  age
                                                                                                  Source null
                                                                                                  approval pathway
                                                                                                  Source null
                                                                                                  biomarker and test
                                                                                                  Source null
                                                                                                  disease stage
                                                                                                  Source null
                                                                                                  limitations
                                                                                                  Source null
                                                                                                  line
                                                                                                  Source null
                                                                                                  prior therapy
                                                                                                  Source null
                                                                                                  regimen
                                                                                                  Source null
                                                                                                  tumor histology
                                                                                                  Source null
                                                                                                  use intent
                                                                                                  not_applicable

                                                                                                  Preserved source evidence · Not medical advice