These highlights do not include all the information needed to use RUXIENCE safely and effectively. See full prescribing information for RUXIENCE. RUXIENCE® (rituximab-pvvr) injection, for intravenous use Initial U.S. Approval: 2019 RUXIENCE (rituximab-pvvr) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of RUXIENCE has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to RITUXAN (rituximab)

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These highlights do not include all the information needed to use RUXIENCE safely and effectively. See full prescribing information for RUXIENCE. RUXIENCE® (rituximab-pvvr) injection, for intravenous use Initial U.S. Approval: 2019 RUXIENCE (rituximab-pvvr) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of RUXIENCE has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to RITUXAN (rituximab)

Medication label

Why this: Advisory · dailymed-prescription

RUXIENCE is indicated for the treatment of adult patients with: •Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. •Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. •Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. •Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. RUXIENCE, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. RUXIENCE, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to one or more Tumor Necrosis Factor (TNF) antagonist therapies. RUXIENCE, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). RUXIENCE is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.

generic_name: rituximab-pvvr
product_names: rituximab-pvvr
ndc: 0069-0238, 0069-0249, 0069-0238-01, 0069-0249-01
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en