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Remicade(infliximab)
Avsola, Inflectra, Remicade, Renflexis (infliximab) is an antibody pharmaceutical. Infliximab was first approved as Remicade on 1998-08-24. It is used to treat ankylosing spondylitis, crohn disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis in the USA. It has been approved in Europe to treat ankylosing spondylitis, crohn disease, psoriasis, psoriatic arthritis, and rheumatoid arthritis amongst others. The pharmaceutical is active against tumor necrosis factor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Avsola, Inflectra, Remicade, Renflexis (discontinued: Ixifi)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Infliximab
Tradename
Proper name
Company
Number
Date
Products
RemicadeinfliximabJohnson & JohnsonN-103772 RX1998-08-24
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
avsolaBiologic Licensing Application2019-12-06
inflectraBiologic Licensing Application2020-08-17
remicadeBiologic Licensing Application2020-05-21
renflexisBiologic Licensing Application2023-01-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ankylosing spondylitisEFO_0003898D013167M45
crohn diseaseEFO_0000384D003424K50
psoriatic arthritisEFO_0003778D015535L40.5
rheumatoid arthritisEFO_0000685D001172M06.9
ulcerative colitisEFO_0000729D003093K51
Agency Specific
FDA
EMA
Expiration
Code
infliximab, Remicade, Janssen Biotech, Inc.
2118-09-23Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AB: Tumor necrosis factor alpha (tnf-alpha) inhibitors
— L04AB02: Infliximab
HCPCS
Code
Description
EJ
Subsequent claims for a defined course of therapy, e.g., epo, sodium hyaluronate, infliximab
J1745
Injection, infliximab, excludes biosimilar, 10 mg
Q5103
Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg
Q5104
Injection, infliximab-abda, biosimilar, (renflexis), 10 mg
Q5109
Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg
Q5121
Injection, infliximab-axxq, biosimilar, (avsola), 10 mg
S9359
Home infusion therapy, anti-tumor necrosis factor intravenous therapy; (e.g., infliximab); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
Clinical
Clinical Trials
370 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Crohn diseaseD003424EFO_0000384K501318233881
Rheumatoid arthritisD001172EFO_0000685M06.92424222678
Ulcerative colitisD003093EFO_0000729K512—10171746
Inflammatory bowel diseasesD015212EFO_000376721182334
Ankylosing spondylitisD013167EFO_0003898M453—5111130
PsoriasisD011565EFO_0000676L40—21141229
Psoriatic arthritisD015535EFO_0003778L40.5——45615
Covid-19D000086382U07.1—22116
Graft vs host diseaseD006086D89.811211—5
UveitisD014605EFO_1001231H20.911—124
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucocutaneous lymph node syndromeD009080EFO_0004246M30.31—5——6
Behcet syndromeD001528EFO_0003780M35.2113——4
VasculitisD014657EFO_0006803M31121——3
Lung neoplasmsD008175C34.90121——3
CachexiaD002100HP_0004326R64—21——3
Juvenile arthritisD001171EFO_0002609M08—12——3
FatigueD005221HP_0012378R53.83—11——2
Macular edemaD008269111——2
Diabetic retinopathyD003930EFO_00037701—1——2
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9—11——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854524——16
ColitisD003092EFO_0003872K52.924——15
Takayasu arteritisD013625EFO_1001857M31.4—3——14
Stevens-johnson syndromeD013262EFO_0004276L51.123———3
Macular degenerationD008268EFO_0001365H35.3011———2
Non-small-cell lung carcinomaD00228922———2
Reperfusion injuryD01542711———2
Hidradenitis suppurativaD017497L73.211———2
Granulomatosis with polyangiitisD014890EFO_0005297M31.3—1——12
Microscopic polyangiitisD055953EFO_1000784M31.7—1——12
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
ScleritisD015423HP_0100534H15.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intestinal diseasesD007410HP_0002242K63.9————22
Atopic dermatitisD003876EFO_0000274L20————11
InfectionsD007239EFO_0000544————11
Cytokine release syndromeD000080424D89.83————11
Kidney transplantationD016030————11
Rheumatic diseasesD012216M79.0————11
Gastrointestinal hemorrhageD006471K92.2————11
Celiac diseaseD002446EFO_0001060K90.0————11
UlcerD014456MPATH_579————11
Pyoderma gangrenosumD017511EFO_0006835L88————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameINFLIXIMAB
INNinfliximab
Description
Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)INFLIXIMAB
Structure (InChI/SMILES or Protein Sequence)
>6UGS:H,A|Infliximab (Remicade) Fab Heavy Chain EVKLEESGGGLVQPGGSMKLSCVASGFIFSNHWMNWVRQSPEKGLEWVAEIRSKSINSATHYAESVKGRFTISRDDSKSA VYLQMTDLRTEDTGVYYCSRNYYGSTYDYWGQGTTLTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKT >6UGS:L,B|Infliximab (Remicade) Fab Light Chain DILLTQSPAILSVSPGERVSFSCRASQFVGSSIHWYQQRTNGSPRLLIKYASESMSGIPSRFSGSGSGTDFTLSINTVES EDIADYYCQQSHSWPFTFGSGTNLEVKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB4G3Y, 5VH3, 5VH4, 5VH5, 6UGS, 6UGT, 6UGU, 6UGV, 6UGW, 6UGX, 6UGY
CAS-ID170277-31-3
RxCUI191831
ChEMBL IDCHEMBL1201581
ChEBI ID—
PubChem CID—
DrugBankDB00065
UNII IDB72HH48FLU (ChemIDplus, GSRS)
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
7124
Protein name
tumor necrosis factor
Protein synonyms
APC1 protein, Cachectin, TNF, macrophage-derived, TNF, monocyte-derived, TNF-a, TNF-alpha, tumor necrosis factor ligand 1F, Tumor necrosis factor ligand superfamily member 2, tumor necrosis factor-alpha, tumor necrotic factor alpha
Uniprot ID
Q9UIV3
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Inflectra - Pfizer
$
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Flixabi - Biogen
$
€
£
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Renflexis - Organon
$
€
£
₣
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Remicade - Johnson & Johnson
$
€
£
₣
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Remicade - Merck Sharp & Dohme
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 38,864 documents
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Safety
Black-box Warning
Black-box warning for: Avsola, Inflectra, Remicade, Renflexis
Adverse Events
Top Adverse Reactions
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95 adverse events reported
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