Classes
DEA Class; Rx
Common Brand Names; Rituxan, Truxima, rituximab-abbs, Ruxience, rituximab-pvvr, rituximab-arrx, Riabni
- DMARDs, Other;
- Antineoplastics, Anti-CD20 Monoclonal Antibodies
Description
Anti-CD20 monoclonal antibody
Used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris
Boxed warnings for severe infusion-related and mucocutaneous reactions, risk of hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy
Indications
Indicated for treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
Indicated in previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab product in combination with chemotherapy, as single-agent maintenance therapy
Indicated for treatment in patients with nonprogressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
Indicated for treatment in patients with previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
Indicated for untreated and previously treated CD20-positive CLL; combined therapy with fludarabine and cyclophosphamide (FC)
Indicated, in combination with methotrexate, for treatment of moderately-to severely-active rheumatoid arthritis (RA) who have had an inadequate response to ≥1 tumor necrosis factor (TNF) antagonist therapies
Indicated for adults with granulomatosis with polyangiitis (GPA; Wegener granulomatosis) in combination with glucocorticoids
Indicated for adults with microscopic polyangiitis (MPA) in combination with glucocorticoids
Adverse Effects
- Angioedema (11%)
- Asthenia (26%), chills (33%), dizziness (10%), fever (53%), headache (19%)
- Pruritus (14%), rash (15%)
- Abdominal pain (14%), diarrhea (10%), nausea (23%), vomiting (10%)
- Leukopenia (14%), lymphopenia (48%), neutropenia (14%), thrombocytopenia (12%)
- Back pain (10%), myalgia (10%)
- Cough (13%), rhinitis (12%)
- Infection (31%), night sweats (15%)
- Nausea (18%)
- Diarrhea (17%)
- Headache (17%)
- Muscle spasms (17%)
- Anemia (16%)
- Peripheral edema (16%)
- Insomnia (14%)
- Arthralgia (13%)
- Cough (13%)
- Fatigue (13%)
- Increased ALT (13%)
- Hypertension (12%)
- Epistaxis (11%)
Warnings
—
Pregnancy and Lactation
Verify pregnancy status in females of reproductive potential prior to initiating therapy
Data unavailable on drug presence in human milk, effects on breastfed children, or effects on milk production
Maximum Dosage
Chronic lymphocytic leukemia (CLL): 500 mg/m2 IV.Non-Hodgkin lymphoma (NHL), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA): 375 mg/m2 IV.Rheumatoid arthritis (RA) and pemphigus vulgaris (PV): 1,000 mg IV.
CLL: 500 mg/m2 IV.NHL, GPA, and MPA: 375 mg/m2 IV.RA and PV: 1,000 mg IV.
NHL or mature B-cell acute leukemia (B-AL), GPA, and MPA only: 375 mg/m2 IV.
2 to 12 yearsNHL or B-AL, GPA, and MPA: 375 mg/m2 IV.1 yearNHL or B-AL only: 375 mg/m2 IV.
6 months or olderNHL or B-AL only: 375 mg/m2 IV.Less than 6 monthsSafety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Rituximab
injectable solution (single-dose vials)
- 10mg/mL (10mL, 50mL vials)
Biosimilars to Rituxan
- Riabni (rituximab-arrx)
- Ruxience (rituximab-rituximab-pvvr)
- Truxima (rituximab-abbs)
