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Rituxan, Mabthera(rituximab)
MabThera, Riabni, Ritemvia, Rituxan, Rituzena, Ruxience, Truxima, Tuxella (rituximab) is an antibody pharmaceutical. Rituximab was first approved as Rituxan on 1997-11-26. It is used to treat b-cell lymphoma, granulomatosis with polyangiitis, lymphoid leukemia, mantle-cell lymphoma, and microscopic polyangiitis amongst others in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia, granulomatosis with polyangiitis, microscopic polyangiitis, non-hodgkin lymphoma, and pemphigus amongst others. The pharmaceutical is active against B-lymphocyte antigen CD20.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
respiratory tract diseasesD012140
nervous system diseasesD009422
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Riabni, Rituxan, Ruxience, Truxima
Combinations
Rituxan hycela
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)
Rituximab
Tradename
Proper name
Company
Number
Date
Products
RituxanrituximabGenentechN-103705 RX1997-11-26
2 products
Show 1 discontinued
Hyaluronidase human
+
Rituximab
Tradename
Proper name
Company
Number
Date
Products
Rituxan Hycelarituximab and hyaluronidase humanGenentechN-761064 RX2017-06-22
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
riabniBiologic Licensing Application2020-12-21
rituxanBiologic Licensing Application2023-06-06
ruxienceBiologic Licensing Application2020-06-05
truximaBiologic Licensing Application2020-12-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
b-cell lymphoma—D016393—
granulomatosis with polyangiitisEFO_0005297D014890M31.3
lymphoid leukemia—D007945C91
mantle-cell lymphoma—D020522C83.1
microscopic polyangiitisEFO_1000784D055953M31.7
rheumatoid arthritisEFO_0000685D001172M06.9
Agency Specific
FDA
EMA
Expiration
Code
rituximab, Rituxan, Genentech, Inc.
2026-09-27Orphan excl.
rituximab / hyaluronidase human, Rituxan Hycela, Genentech, Inc.
2024-06-22Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XC: Monoclonal antibodies, antineoplastic
— L01XC02: Rituximab
HCPCS
Code
Description
J9311
Injection, rituximab 10 mg and hyaluronidase
J9312
Injection, rituximab, 10 mg
Q5115
Injection, rituximab-abbs, biosimilar, (truxima), 10 mg
Q5119
Injection, rituximab-pvvr, biosimilar, (ruxience), 10 mg
Q5123
Injection, rituximab-arrx, biosimilar, (riabni), 10 mg
Clinical
Clinical Trials
1875 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.99214941513259
Large b-cell lymphoma diffuseD016403C83.3861634814255
B-cell chronic lymphocytic leukemiaD015451C91.17211832411207
Mantle-cell lymphomaD020522C83.14789161—127
Rheumatoid arthritisD001172EFO_0000685M06.9111629161281
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0214845169
Waldenstrom macroglobulinemiaD008258C88.0235151166
Burkitt lymphomaD002051C83.7173311—42
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3213132330
Membranous glomerulonephritisD015433EFO_0004254N03.21681216
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.97319230—20284
Follicular lymphomaD008224C82599436—5161
LeukemiaD007938C9521656—488
B-cell lymphomaD01639332366——62
B-cell lymphoma marginal zoneD018442C88.420332—147
Hodgkin diseaseD006689C8121324—244
Myelodysplastic syndromesD009190D468151—121
Myeloid leukemia acuteD015470C92.06121——17
Graft vs host diseaseD006086D89.812121—215
Systemic lupus erythematosusD008180EFO_0002690M321106—115
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C801212———17
Lymphomatoid granulomatosisD008230C83.8812———15
Hairy cell leukemiaD007943C91.4711———14
Multiple myelomaD009101C90.0109———14
Intraocular lymphomaD06409089———13
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340110———10
Biphenotypic leukemia acuteD015456C95.046———9
Plasma cell neoplasmsD05421936———9
Hematologic neoplasmsD01933755———9
Prolymphocytic leukemiaD01546344———8
Show 125 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor t-cell lymphoblastic leukemia-lymphomaD0542182————2
Mycosis fungoidesD009182C84.01————1
DiseaseD004194EFO_0000408R691————1
Immunoglobulin g4-related diseaseD0000777331————1
Bone marrow transplantationD0160261————1
Psoriatic arthritisD015535EFO_0003778L40.51————1
Eyelid diseasesD005141EFO_0009547H02.91————1
Macular degenerationD008268EFO_0001365H35.301————1
Cutaneous candidiasisD0021791————1
Prostatic neoplasmsD011471C611————1
Show 4 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemoglobin sc diseaseD006450EFO_1001797D57.2————11
Cognitive dysfunctionD060825G31.84————11
Off-label useD056687————11
Atopic dermatitisD003876EFO_0000274L20————11
Hematologic diseasesD006402EFO_0005803D75.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRITUXIMAB
INNrituximab
Description
Rituximab, sold under the brand name Rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers. It is given by slow injection into a vein.
Classification
Antibody
Drug classmonoclonal antibodies: chimeric, tumors as target
Image (chem structure or protein)RITUXIMAB
Structure (InChI/SMILES or Protein Sequence)
>1L6X:A|IMMUNOGLOBULIN GAMMA-1 HEAVY CHAIN CONSTANT REGION GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNG KEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL >1L6X:B|Minimized B-domain of Protein A Z34C FNMQCQRRFYEALHDPNLNEEQRNAKIKSIRDDC
Identifiers
PDB1L6X, 2OSL, 4KAQ, 6VJA, 6Y90
CAS-ID174722-31-7
RxCUI121191
ChEMBL IDCHEMBL1201576
ChEBI ID—
PubChem CID—
DrugBankDB00073
UNII ID4F4X42SYQ6 (ChemIDplus, GSRS)
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
931
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Q13963
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Rituxan - Biogen
$
€
£
₣
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Rituxan - Roche
$
€
£
₣
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Ruxience - Pfizer
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 66,963 documents
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Safety
Black-box Warning
Black-box warning for: Riabni, Rituxan, Ruxience, Truxima
Adverse Events
Top Adverse Reactions
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56,475 adverse events reported
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