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Rituximab

rituximab
CD20-targeting Monoclonal Antibody FDA Approved 1997 Genentech/Roche
Route
IV
Half-Life
22 days
FDA Approved
1997
Manufacturer
Genentech/Roche
1. Indications and Usage

Non-Hodgkin lymphoma (including DLBCL, follicular lymphoma, marginal zone lymphoma); Chronic lymphocytic leukemia (CLL) in combination with chemotherapy; Rheumatoid arthritis; Granulomatosis with polyangiitis. Note: Available as biosimilar rituximab-pvvr (Ruxience), rituximab-abbs (Truxima), and rituximab-arrx (Riabni).

2. Dosage and Administration

NHL: 375 mg/m² IV infusion per cycle. CLL: 375 mg/m² cycle 1, 500 mg/m² cycles 2-6. Premedicate with acetaminophen and diphenhydramine.

5. Warnings and Precautions

Fatal Infusion Reactions: Premedicate and monitor. Tumor Lysis Syndrome: Monitor and prophylax. Severe Mucocutaneous Reactions: Stevens-Johnson syndrome reported. Progressive Multifocal Leukoencephalopathy (PML): JC virus reactivation. Hepatitis B Reactivation.

6. Adverse Reactions
Most Common Adverse Reactions

Infusion reactions (77%), fever (53%), chills (33%), infection (31%), asthenia (26%), nausea (23%), headache (19%), angioedema (11%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

12. Clinical Pharmacology
Mechanism of Action

Rituximab is a chimeric monoclonal antibody targeting CD20, a cell-surface antigen expressed on pre-B and mature B lymphocytes and most B-cell lymphomas. Binding triggers complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and direct apoptosis induction in CD20-expressing tumor cells.

Pharmacokinetics

Half-life: 22 days. Route: IV. Refer to the full prescribing information for complete pharmacokinetic data.

14. Clinical Studies
Pivotal Clinical Trials
PRIMA
Rituximab maintenance vs observation in follicular NHL. Phase III, n=1217.
NCT00140582 ↗
GELA LNH-98.5
R-CHOP vs CHOP in DLBCL. Phase III, n=399.
CLL-8
FC vs R-FC in 1L CLL. Phase III, n=817.
NCT00281918 ↗

Clinical efficacy and safety data are available in the full prescribing information and referenced publications.

External Resources

Frequently Asked Questions

What is Rituximab (rituximab) approved for?

Non-Hodgkin lymphoma (including DLBCL, follicular lymphoma, marginal zone lymphoma); Chronic lymphocytic leukemia (CLL) in combination with chemotherapy; Rheumatoid arthritis; Granulomatosis with polyangiitis. Note: Available as biosimilar rituximab-pvvr (Ruxience), rituximab-abbs (Truxima), and rituximab-arrx (Riabni).

How does Rituximab (rituximab) work?

Rituximab is a chimeric monoclonal antibody targeting CD20, a cell-surface antigen expressed on pre-B and mature B lymphocytes and most B-cell lymphomas. Binding triggers complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and direct apoptosis induction in CD20-expressing tumor cells.

What are the most common side effects?

Infusion reactions (77%), fever (53%), chills (33%), infection (31%), asthenia (26%), nausea (23%), headache (19%), angioedema (11%)

View by Tumor Type
Non-Hodgkin Lymphoma CLL Follicular Lymphoma
Medical Disclaimer: This page is intended as a navigational reference to FDA prescribing information. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions.