Drug updated on 11/4/2024
| 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-Hodgkins Lymphoma (NHL) as a single agent
- Indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkins 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-Hodgkins 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-Hodgkins 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-Hodgkins 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) (Wegeners 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.
Latest News
Summary
- This summary is based on the review of 30 systematic review(s)/meta-analysis(es). [1-30]
- Rituximab significantly improves remission rates in patients with Granulomatosis with Polyangiitis (GPA) compared to cyclophosphamide and azathioprine, with benefits extending across diverse demographics, including pediatric patients, and being particularly effective in relapsing disease forms.
- In Pemphigus Vulgaris (PV), rituximab achieves complete or partial remission in almost all pediatric and juvenile cases, demonstrating a significant improvement in remission rates compared to control groups (OR (odds ratio): 2.26) and lower recurrence rates (OR: 0.36).
- In Non-Hodgkin Lymphoma (NHL), the (R)-CDOP regimen has been evaluated for cardiotoxicity, showing a lower risk compared to (R)-CHOP, particularly beneficial for elderly patients.
- Rituximab is considered safe and effective in patients with rheumatoid arthritis and myasthenia gravis, with case studies indicating no worsening of myasthenic symptoms when treated with glucocorticoids, methotrexate, and rituximab.
- In Granulomatosis with Polyangiitis (GPA), the systematic review noted no specific safety concerns associated with rituximab treatment.
- For Pemphigoid diseases, methotrexate treatment was associated with significant adverse effects, and while rituximab shows benefits in patients with end-stage kidney disease (ESKD), further investigation is warranted regarding its safety.
- In Pemphigus Vulgaris (PV), most cases reported only minor adverse events following rituximab treatment, indicating a generally favorable safety profile.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rituxan (rituximab) Prescribing Information. | 2021 | Genentech, Inc., South San Francisco, CA |