Drug Name |
Rituximab |
Drug ID |
BADD_D01953 |
Description |
Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences [A40017], [FDA label]. It was originally approved by the U.S. FDA in 1997 as a single agent to treat patients with B-cell Non-Hodgkin's Lymphoma (NHL) [L4811], however, has now been approved for a variety of conditions [FDA label]. On November 28, 2018, the US FDA approved _Truxima_, the first biosimilar to Rituxan (Rituximab) [L4808]. |
Indications and Usage |
Rituximab is indicated in the following conditions [FDA label]:
Non–Hodgkin’s Lymphoma (NHL)
Chronic Lymphocytic Leukemia (CLL)
Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
Moderate to severe Pemphigus Vulgaris (PV) in adult patients
The biosimilar (approved in November 2018), _Truxima_, is indicated For the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy [L4808].
In September 2019, the rituximab injection was approved along with glucocorticoids to manage granulomatosis with polyangiitis (GPA) in addition to microscopic polyangiitis (MPA) in children of at least 2 years of age [L8920]. |
Marketing Status |
approved |
ATC Code |
L01FA01 |
DrugBank ID |
DB00073
|
KEGG ID |
D02994
|
MeSH ID |
D000069283
|
PubChem ID |
Not Available
|
TTD Drug ID |
D09EXD
|
NDC Product Code |
71124-0003; 50242-053; 50242-052; 50242-051 |
UNII |
4F4X42SYQ6
|
Synonyms |
Rituximab | CD20 Antibody, Rituximab | Rituximab CD20 Antibody | Mabthera | IDEC-C2B8 Antibody | IDEC C2B8 Antibody | IDEC-C2B8 | IDEC C2B8 | GP2013 | Rituxan |