LABELS · 1f47d28b-1604-4e95-a668-46d81e4b5b27

Ruxience

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-08-26
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RUXIENCE. Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML) Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4) , Adverse Reactions (6.3) ] . WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. • Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RUXIENCE infusion for severe reactions ( 5.1 , 6.1 ). • Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). • Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 , 6.3 ).

Indications and usage: exact source text

1 INDICATIONS AND USAGE RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). o Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. o 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. o 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. o Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. • Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). o Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). • 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 ( 1.3 ). • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). • Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) 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. 1.2 Chronic Lymphocytic Leukemia (CLL) 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. 1.3 Rheumatoid Arthritis (RA) 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. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) 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). 1.5 Pemphigus Vulgaris (PV) RUXIENCE is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.

Full extracted label fields

application numbers

BLA761103

boxed warning exact

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RUXIENCE. Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML) Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4) , Adverse Reactions (6.3) ] . WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. • Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RUXIENCE infusion for severe reactions ( 5.1 , 6.1 ). • Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). • Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 , 6.3 ).

brand names

Ruxience

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f941fc61-f7a3-4e4a-ab7c-87c1667fa05b

generic names

RITUXIMAB-PVVR

1f47d28b-1604-4e95-a668-46d81e4b5b27

indications and usage exact

1 INDICATIONS AND USAGE RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). o Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. o 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. o 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. o Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. • Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). o Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). • 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 ( 1.3 ). • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). • Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) 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. 1.2 Chronic Lymphocytic Leukemia (CLL) 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. 1.3 Rheumatoid Arthritis (RA) 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. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) 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). 1.5 Pemphigus Vulgaris (PV) RUXIENCE is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.

indications and usage tables exact

is original packager

true

manufacturer names

Pfizer Laboratories Div Pfizer Inc

matched search terms

lymphoma
leukemia
tumor

package ndcs

0069-0238-01
0069-0249-01

product ndcs

0069-0238
0069-0249

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage, Pemphigus Vulgaris (PV) ( 1.5 ) 6/2025 Dosage and Administration ( 2 ) 6/2025 Warnings and Precautions ( 5 ) 6/2025

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source batch

file

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Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

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brand names

Ruxience

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exact text: 1 INDICATIONS AND USAGE RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). o Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. o Previously untreated follicular, CD20-posi
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approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 2 · positive indication candidate

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exact text: 1 INDICATIONS AND USAGE RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). o Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. o 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. o 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. o Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. • Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). o Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). • Rheumato
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Passage 4 · unclassified context

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exact text: • 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 ( 1.3 ).
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Passage 5 · unclassified context

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exact text: • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ).
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Passage 6 · unclassified context

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exact text: TNF antagonist therapies ( 1.3 ). • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). • Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) 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. • Prev
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exact text: • Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ).
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exact text: A) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). • Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) 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 chemotherap
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exact text: 1.1 Non-Hodgkin's Lymphoma (NHL) RUXIENCE is indicated for the treatment of adult patients with:
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Passage 8 · unclassified context

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exact text: with glucocorticoids ( 1.4 ). • Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) 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 combinatio
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start: 1621

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exact text: 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) 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 un
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context exact
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.
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end: 1973
end exclusive: true
exact text: • 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.
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start: 1717

source url

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tumor histology: Source null

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Passage 10 · unclassified context

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exact text: 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. 1.
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qualifier mentions

context exact
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ow-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
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uding stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
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exact text: • 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.
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source text sha256: a99f083abc25f7ae819490225864e14220c7e8c8b04b916a7bfcf4d38fd8a4b1
start: 1974

source url

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spl effective date

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biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 11 · positive indication candidate

application numbers

BLA761103

brand names

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classification reasons

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clinical review status

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exact text: enance 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. 1.2 Chronic Lymphocytic Leukemia (CLL) RUXIENCE, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously t
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exact text: is indicated
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start: 1566

qualifier mentions

context exact
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context exact
• Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
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2160
context exact
reviously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
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regulatory links

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exact text: • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
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start: 2158

source url

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spl effective date

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limitations: Source null
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prior therapy: Source null
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tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 12 · positive indication candidate

application numbers

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end exclusive: true
exact text: y. • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) 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. 1.3 Rheumatoid Arthritis (RA) RUXIENCE, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inad
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start: 2463

qualifier mentions

context exact
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context exact
t patients with previously untreated and previously treated CD20-positive CLL.
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2578
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context exact
(FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
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context exact
1.2 Chronic Lymphocytic Leukemia (CLL) 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.
kind
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polarity
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2578
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in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL
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end exclusive: true
exact text: 1.2 Chronic Lymphocytic Leukemia (CLL) 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.
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start: 2355

source url

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limitations: Source null
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prior therapy: Source null
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tumor histology: Source null

use intent

tumor_directed_candidate

Passage 13 · positive indication candidate

application numbers

BLA761103

brand names

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classification reasons

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Preserved source evidence · Not medical advice