Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 100 mg/10 mL [10 mg/mL] and 500 mg/50 mL [10 mg/mL]) |
| Drug Class | CD20-directed cytolytic antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with relapsed or refractory, low grade or follicular, CD20-positive B cell Non-Hodgkin’s Lymphoma (NHL) as a single agent.
- Indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) in combination with first line chemotherapy and, in adult patients achieving a complete or partial response to a rituximab product in combination with chemotherapy as single-agent maintenance therapy.
- Indicated for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20- positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
- Indicated for the treatment of adult patients with previously untreated diffuse large B-cell, CD20-positive Non-Hodgkin’s Lymphoma (NHL) in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
- Indicated for the treatment of pediatric patients aged 6 months and older with mature B-cell Non-Hodgkin’s Lymphoma (NHL) and mature B-cell acute leukemia (B-AL) - previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.
- Indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC).
- Indicated for the treatment of rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies.
- Indicated for the treatment of granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA) in adult and pediatric patients 2 years of age and older in combination with glucocorticoids.
- Indicated for the treatment of moderate to severe pemphigus vulgaris (PV) in adult patients.
Summary
- Rituximab (Rituxan) is indicated for the treatment of various conditions including follicular lymphoma, antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides, rheumatoid arthritis, diffuse large B-cell lymphoma (DLBCL), granulomatosis with polyangiitis, and pemphigus vulgaris.
- A total of 42 systematic reviews/meta-analyses were reviewed to gather information about rituximab's safety and effectiveness in comparison to other drugs.
- In patients with advanced follicular lymphoma, rituximab showed significant progression-free survival benefits as maintenance therapy after first-line or relapse treatments. However, it was associated with somewhat higher toxicity compared to observation alone.
- For ANCA-associated vasculitis remission achievement and maintenance, rituximab proved effective and safer than azathioprine respectively. It also demonstrated comparable efficacy to cyclophosphamide in achieving remission.
- In treating rheumatoid arthritis patients, rituximab significantly decreased anti-citrullinated peptide antibodies titers - a benefit not seen with TNF inhibitors or abatacept, indicating its direct immunomodulatory effect that could be pivotal for certain patient profiles.
- When combined with the CHOP chemotherapy regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone), rituximab is beneficial for patients suffering from DLBCL, enhancing their outcomes considerably making it a standard management option for this condition.
- In pediatric populations suffering from B-cell Non-Hodgkin’s Lymphoma, rituximab shows similar benefits as those observed in adult populations.
- Rituximab's usage during pregnancy, particularly while managing diseases such as ANCA-associated vasculitis, suggests potential inclusion into management plans where benefits might outweigh risks but requires careful consideration and monitoring.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rituxan (rituximab) Prescribing Information. | 2021 | Genentech Inc., South San Francisco, CA |