Notification



Notification Issue Date:



Policy Attachment


Attachment to Policy # 08.00.50t


Attachment:A

Policy #:08.00.50t

Description:Dosing and Frequency Requirements For Rituximab (Rituxan®) infusion and related biosimilars, and rituximab/hyaluronidase human for subcutaneous injection (Rituxan Hycela®)

Title:Rituximab (Rituxan®) Infusion and Related Biosimilars, and Rituximab/Hyaluronidase Human for Subcutaneous Injection (Rituxan Hycela®)



DOSING AND FREQUENCY REQUIREMENTS FOR RITUXIMAB (RITUXAN®) INFUSION AND RELATED BIOSIMILARS (E.G., RITUXIMAB-ABBS [TRUXIMA®]), AND RITUXIMAB/HYALURONIDASE HUMAN FOR SUBCUTANEOUS INJECTION (RITUXAN HYCELA®)

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this Policy to ensure consistency with the most recently published recommendations for the use of rituximab (Rituxan®) infusion or related biosimilars (e.g., rituximab-abbs [Truxima®]), or rituximab/hyaluronidase human for subcutaneous injection (Rituxan Hycela®). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (ie, published peer-reviewed literature) in order to request coverage for an amount of rituximab (Rituxan®) infusion or related biosimilars (e.g., rituximab-abbs [Truxima®]), or rituximab/hyaluronidase human for subcutaneous injection (Rituxan Hycela®) outside of the Dosing and Frequency Requirements listed in this Policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for rituximab (Rituxan®) infusion or related biosimilars (e.g., rituximab-abbs [Truxima®]), or rituximab/hyaluronidase human for subcutaneous injection (Rituxan Hycela®).

COMMON CHEMOTHERAPY REGIMEN ABBREVIATIONS USED THROUGHOUT THE POLICY:
    RCHOPa (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
    DHAPb (dexamethasone, cisplatin, and cytarabine)
    ESHAPc (etoposide, methylprednisolone, high-dose cytarabine, and cisplatin)
    ICEd (ifosfamide, carboplatin, and etoposide)
    dose-adjusted EPOCHe (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin)
    RCVPf (rituximab, cyclophosphamide, vincristine, and prednisone)
    GDPg (gemcitabine, dexamethasone, and cisplatin; or gemcitabine, dexamethasone, and carboplatin)
    MINEh (mesna, ifosfamide, mitoxantrone, and etoposide)

DOSING AND FREQUENCY REQUIREMENTS FOR RITUXIMAB (RITUXAN®) INFUSION AND RELATED BIOSIMILARS (E.G., RITUXIMAB-ABBS [TRUXIMA®])
Indication
Dosing and Frequency
Antineutrophil Cytoplasmic Antibodies (ANCA) -associated vasculitides (Granulomatosis with Polyangiitis, microscopic polyangiitis [MPA], eosinophilic granulomatosis with polyangiitis [EGPA] [formerly Churg-Strauss syndrome], 22, 28 Pauci-immune glomerulonephritis) Induction: One of the following regimens:
  • 375 mg/m2 once weekly for 4 weeks2, 3, 6, 22, 28, 35, 36, 51, 52, 53, 54, 116
  • 500 mg on Days 0 and 14 160
  • Two 1000 mg intravenous infusions separated by 2 weeks 51, 52, 53, 54, 116

Maintenance: Repeat one of the following regimens:
  • 375 mg/m2 repeated every 6 months 54, 116
  • 500 mg as a single dose, repeated every 6 months for 3 doses 160
  • 1000 mg as a single dose, repeated every 6 months for 2 years 53, 54, 116
  • 1000 mg as a single dose, repeated every 4 months for 2 years 52, 116
  • two-500 mg intravenous infusions separated by 2 weeks, followed by 500 mg every 6 months thereafter, based on clinical evaluation 6
  • two-1000 mg infusions (separated by 2 weeks)51

Retreatment 6: May retreat after relapse with one cycle of either regimen:
  • 375 mg/m2 once weekly for 4 weeks 51, 53
  • 1000 mg as a single dose, repeated every 6 months for 2 years 53, 116
Anemia, autoimmune hemolytic Induction: 375 mg/m2 once weekly for 4 weeks1, 2, 3, 18, 20, 23, 138 or two 1000 mg intravenous infusions separated by 2 weeks118
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Retreatment: 375 mg/m2 once weekly for 4 weeks may be warranted for relapse1, 18, 23, 129, 130, 138
Castleman's Disease (CD), multicentric Induction: 375 mg/m2 IV once weekly for 4 to 8 weeks 2, 8, 46, 131
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Castleman's Disease (CD), unicentric 49, 50 Induction: 375 mg/m2 IV once weekly for 4 weeks 132
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Central nervous system cancers
For leptomeningeal metastases 24, 25, 50
    Induction: 25 mg intraventricular or IT on days 1, 4, 8, 11, 15, 18, 22, 25 for one 28-day cycle
    Maintenance: 25 mg intraventricular or IT on day 1 of a 28-day cycle until disease progression or unacceptable toxicity

For primary central nervous system lymphoma
    • With high-dose MTX as a 14-day cycle for 4-6 cycles
      Induction: Rituximab 375 mg/m2 IV on day 8 50
    • With high-dose MTX/temozolomide, followed by etoposide/high-dose cytarabine as a 14-day cycle for 8-13 cycles
      Induction: Rituximab 375 mg/m2 IV on day 3 of cycles 1-6 only 50
    • With high-dose MTX/vincristine/procarbazine, followed by high-dose cytarabine as a 14-day cycles for 5-7 cycles
      Induction: Rituximab 500 mg/m2 IV on day 1 50
    • As a single agent
      Induction: Rituximab 375 mg/m2 IV on day 1, given weekly for 8 weeks 50
    • With temozolomide 50
      Induction: Rituximab 375 mg/m2 IV on day 1 of a 28-day cycle for 4 cycles
      or
      Rituximab 750 mg/m2 IV on days 1, 8, 15, 22 of a 28-day cycle for 1-2 cycles
Idiopathic membranous nephropathy (resistant) Induction: one of the following:
  • 375 mg/m2 once weekly for 2 doses 178, 179, 180
  • 375 mg/m2 once weekly for 4 doses 175, 177, 179, 180, 181; repeat cycle once at 6 months 175
  • 1,000 mg on days 1 and 15; repeat cycle at 6 months 176

Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.

Retreatment: For cases of relapses, administer 375 mg/m2 once weekly for 4 doses 177
Toxicities related to Immune Checkpoint InhibitorsTreatment of immunotherapy-related encephalitis after viral causes have been excluded in individuals positive for autoimmune encephalopathy antibody, or who have had limited or no improvement after 7-14 days on pulse-dose methylprednisolone with or without intravenous immune globulin.
    Rituximab: 1,000 mg for 2 doses. 50, 133
Leukemia, Philadelphia chromosome-negative acute lymphoblastic (ALL) 47, 48, 49As induction/consolidation therapy
  • As a component of GRAALL-2005 regimen (daunorubicin, vincristine, prednisone, pegaspargase, and cyclophosphamide) with rituximab for CD20-positive disease for individuals aged <60 years (adolescents, young adults, and adults). Total of 16 infusions (or 18 in the case of salvage reinduction) 127
    • Induction: Rituximab 375 mg/m2 on days 1, 7
    • Salvage reinduction, when needed: Rituximab 375 mg/m2 on days 1, 7
    • Consolidation blocks 1, 3, 4, and 6 (4 infusions of Rituximab 375 mg/m2)
    • Late intensification: Rituximab 375 mg/m2 on days 1, 7
    • Late consolidation blocks 7 and 9 (2 infusions of Rituximab 375 mg/m2)
    • Maintenance (6 infusions of Rituximab 375 mg/m2)
  • As a component of HyperCVAD (hyper-fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) regimen alternating with high-dose methotrexate and cytarabine with or without rituximab for CD20-positive disease in adolescents, young adults, and adults.
    • Induction: Rituximab 375 mg/m2 on day 1 of a 21-day cycle. Alternate HyperCVAD cycles with high-dose methotrexate and cytarabine cycles (4 cycles of each for a total of 8 cycles)48, 50
    or
    • Induction: Rituximab 375 mg/m2 on days 1, 11 of hyper-CVAD cycles if CD20 was greater than or equal to 20% 48
    • Consolidation: Cycles 1-4: Rituximab 375 mg/m2 on days 1, 11 of hyper-CVAD cycles, and on days 1, 8 of liposomal daunorubicin- or MTX-cytarabine cycles, for a total of 8 doses, if CD20 was greater than or equal to 20% 48
    • Intensification: Rituximab 375 mg/m2 days 1, 11 of hyper-CVAD cycles during months 6 and 18 of maintenance therapy if CD20 was greater than or equal to 20% 48

As induction therapy as a component of idarubicin, dexamethasone, vincristine, cyclophosphamide, and cytarabine, with or without rituximab for CD20-positive disease (moderate intensity) in adults aged ≥65 years
    • Rituximab 375 mg/m2 for a total of 8 doses128

Relapsed/refractory disease, as a component of MOpAD regimen (methotrexate, vincristine, pegaspargase, dexamethasone) with rituximab for CD20-positive disease
    • Rituximab 375 mg/m2 on Days 1 and 15 during the first four cycles of therapy126
Leukemia, Philadelphia chromosome-positive acute lymphoblastic (ALL) 97 Relapsed/refractory disease that is refractory to tyrosine kinase inhibitors (TKIs), as a component of MOpAD regimen (methotrexate, vincristine, pegaspargase, dexamethasone) with rituximab for CD20-positive disease
  • Rituximab 375 mg/m2 on Days 1 and 15 during the first four cycles of therapy126
Lupus Nephritis, refractory Induction: One of the following regimens:
  • 375 mg/m2 once weekly for 4 doses 2, 138, 173
  • Two 1000 mg intravenous infusions separated by 2 weeks 138, 174

Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Lymphoma, Hodgkin


Primary treatment with involved site radiation therapy (ISRT) for stage IB or IIB disease or bulky stage IA or IIA disease, or with or without ISRT for stage III-IV disease, as a component in one of the following regimens:
  • ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 6-8 cycles of a 28-day cycle 50, 59, 60
    • Induction:
      • Rituximab 375 mg/m2 on Day 1 of each cycle or
      • Rituximab 375 mg/m2 on Days 1, 8, 15, and 22 of cycle 1 only
  • RCHOPa
    • Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle. Administer 6 cycles 49, 50, 57
  • RCVPf
    • Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles 30, 50

Primary treatment as a single agent for stage IIIA or IVA disease
    Induction: 375 mg/m2 once weekly for 4 weeks 30, 50

Second-line or subsequent treatment for refractory, relapsed, or progressive disease
  • As a single agent with or without ISRT
    Induction: 375 mg/m2 once weekly for 4 weeks 3, 4, 5, 17, 29, 30, 31
  • In combination with any of the following regimens:
    • DHAPb
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28- day cycle. Administer for 2-4 cycles for transplant candidates or 4-8 cycles for nontransplant candidates 30, 49, 50
    • ESHAPc
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28- day cycle. Administer for 2-4 cycles for transplant candidates or 4-8 cycles for nontransplant candidates 30, 49, 50
    • ICEd
      Induction: Rituximab 375 mg/m2 on Day 1 of a 14- or 21-day cycle. Administer for 2-4 cycles for transplant candidates or 4-8 cycles for nontransplant candidates 30, 49, 50
    • IGEV (ifosfamide, gemcitabine, and vinorelbine) regimen
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle. Administer for 2-4 cycles for transplant candidates or 4-8 cycles for nontransplant candidates 30, 49, 50

May be considered as maintenance therapy for individuals treated with rituximab alone for refractory, relapsed, or progressive disease
  • Maintenance: Rituximab 375 mg/m2 once weekly for 4 weeks. Repeat every 6 months for a maximum of 2 years.17, 50
High Grade B-Cell Lymphomas Induction therapy for high-grade B-cell lymphomas with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma) or high-grade B-cell lymphomas, not otherwise specified as a component of one of the following:
  • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
  • Hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles, alternating with methotrexate and cytarabine regimen with rituximab. 50
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles, alternating with Hyper-CVAD with rituximab. 50
  • R-CODOX-M (rituximab, cyclophosphamide, vincristine, and doxorubicin with methotrexate) regimen alternating with R-IVAC (rituximab, ifosfamide, etoposide, and cytarabine) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle (or when post-nadir ANC is 1000 cells/mm3 or greater) for 2 cycles (Cycle 1 and 3), alternating with IVAC + R. 50
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle (or when post-nadir ANC is 1000 cells/mm3 or greater) for 2 cycles (Cycle 2 and 4), alternating with R-CODOX-M. 50

Induction therapy for high-grade B-cell lymphomas, not otherwise specified as a component of RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen (Note: RCHOP has been associated with inferior outcomes for patients with high-grade B-cell lymphomas with translocations of MYC and BCL2 and/or BCL6 [double/triple hit lymphoma])
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles, followed by radiation. 50

Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease in:
  • Individuals with intention to proceed to transplant as a component of one of the following:
    • DHAPb
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28-day cycle for 6-10 cycles. 50
    • DHAX (dexamethasone, cytarabine, and oxaliplatin)
      Induction: Rituximab 375 mg/m2 on Day 1. 50
    • ESHAPc
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28-day cycle for 6-8 cycles. 50
    • GDPg
      Induction: GDP with carboplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles. 50
      Induction: GDP with cisplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
    • GemOX (gemcitabine and oxaliplatin)
      Induction: Rituximab 375 mg/m2 on Day 1 of a 14-day cycle (NCCN-Preferred) or 21-day cycle for 6 cycles. 50
    • ICEd
      Induction: Rituximab 375 mg/m2 on Day 1 of a 14-day cycle for 3 cycles. 50
    • MINEh
      Induction: Rituximab 375 mg/m2 on Day 1 of Cycles 1-3, followed by Rituximab 375 mg/m2 on Day 7 of Cycle 3. Cycles are 21 days long. 50
  • noncandidates for transplant in one of the following:
    • as a single agent
      Induction: Rituximab 375 mg/m2 once weekly for 8 weeks.
    • in combination with lenalidomide (non-germinal center lymphoma)
      Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle until disease progression or unacceptable toxicity. 50
    • in combination with bendamustine
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
    • as a component of one of the following:
      • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine)
        Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles. 50
      • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin)
        Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
      • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone)
        Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
      • GDPg
        Induction: GDP with carboplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles. 50
        Induction: GDP with cisplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
      • GemOX
        Induction: Rituximab 375 mg/m2 on Day 1 of a 14-day cycle (NCCN-Preferred) or 21-day cycle for 6 cycles. 50
      • gemcitabine and vinorelbine regimen with rituximab
        Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
Lymphoma, Non-Hodgkin (NHL): AIDS-related B-Cell Lymphoma
In combination with growth factor support for AIDS-related Burkitt lymphoma as a component of one of the following:
  • modified CODOX-M (cyclophosphamide, doxorubicin, and vincristine, with intrathecal methotrexate and cytarabine followed by high-dose systemic methotrexate) regimen alternating with IVAC (ifosfamide, cytarabine, etoposide, and intrathecal methotrexate) regimen (NCCN-preferred therapy)
    Induction: Rituximab 375 mg/m2 on day 1 of each cycle, up to 6 cycles 17, 61
  • R-EPOCH (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen (NCCN-preferred therapy)
    Induction: Rituximab 375 mg/m2 49, 50, 185
  • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen
    Induction: Rituximab 375 mg/m2 on days 1, 11 of hyper-CVAD cycles if CD20 was greater than or equal to 20% 48
    Consolidation during cycles 1-4: Rituximab 375 mg/m2 on days 1, 11 of hyper-CVAD cycles, and on days 1, 8 of liposomal daunorubicin- or MTX-cytarabine cycles, for a total of 8 doses, if CD20 was greater than or equal to 20% 48
    Intensification: Rituximab 375 mg/m2 days 1, 11 of hyper-CVAD cycles during months 6 and 18 of maintenance therapy if CD20 was greater than or equal to 20% 48

In combination with growth factor support for CD20+ AIDS-related diffuse large B-cell lymphoma and HHV8-positive diffuse large B-cell, not otherwise specified (NOS) as a component of one of the following:
  • R-EPOCH (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen (NCCN-preferred therapy)
    Induction: Rituximab 375 mg/m2 49, 50, 185
  • RCHOPa
    Induction and Maintenance: Rituximab 375 mg/m2 on day 1, prior to CHOP regimen. Repeat cycle every 3 weeks for at least 4 cycles, or for 2 cycles after complete response17, 66, 67

Second-line therapy for relapse of AIDS-related Burkitt lymphoma as a component of:
  • dose-adjusted EPOCHe regimen with rituximab (if not previously given as first-line therapy)
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
  • RICE (rituximab, ifosfamide, carboplatin, and etoposide) regimen (in combination with intrathecal methotrexate if not previously given)
    Induction: Rituximab 375 mg/m2 on Day 1 of a 14-day cycle for 3 cycles. 50
  • IVAC (rituximab, ifosfamide, cytarabine, etoposide) regimen (in combination with intrathecal methotrexate if not previously given)
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 4 cycles. 50
  • RGDP (rituximab, gemcitabine, dexamethasone, cisplatin) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
  • High-dose cytarabine + rituximab regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles. 50

Second-line or subsequent therapy for relapse of AIDS-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS) in one of the following:
  • For individuals with intention to proceed to transplant as a component of one of the following regimens:
    • DHAPb
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28-day cycle for 6-10 cycles. 50, 106, 107
    • DHAX
      Induction: Rituximab 375 mg/m2 on Day 1. 50
    • ESHAPc
      Induction: Rituximab 375 mg/m2 Day 1 for 6-8 cycles. Cycles are 21- or 28-days in length.50, 108
    • GDPg
      Induction: with cisplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50, 101
      Induction: with carboplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles. 50, 101
    • GemOX (gemcitabine and oxaliplatin)
      Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 14-days (NCCN-preferred) or 21-days in length.50, 102
    • ICEd
      Induction: Rituximab 375 mg/m2 Day 1 for 3 cycles. Cycles are 14-days in length. 50, 109
    • MINEh
      Induction: Rituximab 375 mg/m2 Day 1 of Cycles 1-3, and Day 7 of Cycle 3. Cycles are 21-days in length. 50
  • For individuals who are not candidates for transplant
    • as a single agent
      Induction: Rituximab 375 mg/m2 weekly for 8 weeks 49, 50
    • in combination with bendamustine
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
    • in combination with lenalidomide (for non-germinal center diffuse large B-cell lymphoma)
      Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle until disease progression or unacceptable toxicity. 50
    • gemcitabine and vinorelbine
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
    • as a component of CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine)
      Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 28-days in length 50
    • as a component of dose-adjusted EPOCHe
      Induction: Rituximab 375 mg/m2 on day 1 of a 21-day cycle, up to 6 cycles17, 58, 63, 64
    • as a component of CEOP (cyclophosphamide, etoposide, vincristine, and prednisone)
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50, 101
    • as a component of GDPg
      Induction: with cisplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50, 101
      Induction: with carboplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles. 50, 101
    • as a component of GemOX
      Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 14-days (NCCN-preferred) or 21-days in length.50, 102
Lymphoma, Non-Hodgkin (NHL): Burkitt lymphoma

Induction therapy for low- or high-risk disease as a component of:
  • CODOX-M (cyclophosphamide, doxorubicin, and vincristine, with intrathecal methotrexate and cytarabine followed by high-dose systemic methotrexate) regimen (original or modified) with rituximab
    • Original CODOX-M - Induction for low risk disease: Cycles 1-3 - Rituximab 375 mg/m2 on Day 1 of each cycle. Cycles are 28-days in length17, 50
    • Modified CODOX-M - Induction for low risk disease: Cycles 1-3 - Rituximab 375 mg/m2 on Day 1 of each cycle. Cycles are 28-days in length (or when post-nadir ANC is 1000 cells/mm3) 50
  • CODOX-M alternating with IVAC (ifosfamide, cytarabine, etoposide, and intrathecal methotrexate) regimen (original or modified) with rituximab
    • Original CODOX-M - Induction for high risk disease: Cycles 1-3 - Rituximab 375 mg/m2 on Day 1 of each cycle. Cycles are 28-days in length17, 50
    • Modified CODOX-M - Induction for high risk disease: Rituximab 375 mg/m2 on Day 1 for a total of 2 cycles. Cycles are 28-days in length17, 50
  • dose-adjusted EPOCHe regimen with rituximab and intrathecal methotrexate
    Induction: Cycles 1-6 - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle17, 50
  • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 for a total of 8 doses (4 doses with Cycles A 1-4 and 4 doses with Cycles B 1-4). Cycles are 21-days in length (or earlier is count recovery occurs, minumum 14 days). Administer for 4 cycles alternating with high-dose methotrexate and cytarabine regimen with rituximab 50
    Induction: Rituximab 375 mg/m2 on Day 1 for a total of 8 doses (4 doses with Cycles A 1-4 and 4 doses with Cycles B 1-4). Cycles are 21-days in length (or earlier is count recovery occurs, minumum 14 days). Administer for 4 cycles alternating with HyperCVAD with rituximab 50

Second-line therapy for relapse of Burkitt lymphoma > 6 months following complete response to induction therapy, or for individuals with partial response to second-line therapy as additional second-line therapy (if not previously given) for relapse or refractory disease as a component of one of the following:
  • dose-adjusted EPOCHe regimen with rituximab and intrathecal methotrexate
    See rituximab regimen under Induction therapy for low- or high-risk disease (above)
  • ICEd regimen with rituximab, and with intrathecal methotrexate if not previously given
    Induction: Maximum of 3 cycles - Rituximab 375 mg/m2 on Day 1 and 3 of Cycles 1 and 2, and Day 1 only for Cycle 3 49, 90
  • RIVAC (rituximab, ifosfamide, cytarabine, and etoposide) regimen with intrathecal methotrexate if not previously given
    Induction: Rituximab 375 mg/m2 on day 1 for a total of 2 cycles. Cycles are 28-days in length, up to 6 cycles49, 50, 61
  • RGDP (rituximab, gemcitabine, dexamethasone, and cisplatin) regimen
    See rituximab regimen under second-line therapy for Diffuse large B-cell lymphoma 101
  • HDAC (high-dose cytarabine) with rituximab regimen
    Induction: Rituximab 375 mg/m2 on day 1 of each cycle for 4 cycles17, 50
Lymphoma, Non-Hodgkin (NHL): chronic lymphocytic leukemia (CLL); small lymphocytic lymphoma (SLL)70

First-line therapy
  • With chlorambucil or bendamustine
    Induction: Cycle 1 - Rituximab 375 mg/m2 Day 1. Cycles 2-6 - Rituximab 500 mg/m2 Day 1. Cycles are 28-days in length. 2, 50
  • With alemtuzumab (Campath®) 50
    • If white blood cell count (WBC) less than 50,000/mcL:
      Induction: Rituximab 375 mg/m2 weekly (on Day 1 of each week) of a 28-day cycle (maximum 2 cycles)
    • If WBC is 50,000/mcL or greater:
      Induction: Rituximab 100 mg/m2 Day 1, 275 mg/m2 Day 2, then 375 mg/m2 weekly beginning Week 2. Cycles are 28 days. (maximum 2 cycles)
  • With high-dose methylprednisolone 50
    Induction: Cycle 1 - Rituximab 100 mg Day 1, 375 mg/m2 minus 100 mg Day 2, 375 mg/m2 Days 3, 5, 8, 15, 22. Cycles 2-3 - Rituximab 375 mg/m2 Days 1, 8, 15, 22. Cycles are 28-days in length.
  • With fludarabine (FR)
    • Option 1: 3, 50
      Induction: Cycle 1 - Rituximab 50 mg/m2 Day 1, 325 mg/m2 Day 3, 375 mg/m2 Day 5. Cycles 2-6 - Rituximab 375 mg/m2 Day 1. Administer Cycles every 28 days for 6 cycles.
      or
    • Option 2: 32
      Induction: Rituximab 375 mg/m2 weekly for 4 doses, on a 28-day cycle.
      Consolidation: Rituximab 375 mg/m2 monthly in a 28-day cycle for 4 cycles.
      Maintenance: Rituximab 150 mg/m2 monthly in a 28-day cycle for 12 cycles.
      or
    • Option 3: 3
      Induction: Cycle 3 - Rituximab 50 mg Day 1, 150 mg Day 2, 375 mg/m2 minus 200 mg Day 3. Cycles 4-6 - Rituximab 375 mg/m2 Day 1. Cycles are 28-days in length.
      or
    • Option 4: 2
      Induction: Cycle 1 - Rituximab 375 mg/m2 Days 1 and 4. Cycles 2-6 - Rituximab 375 mg/m2 Day 1. Cycles are every 28 days. 2
      Consolidation: Rituximab 375 mg/m2 weekly for 4 doses.
  • FCR (fludarabine, cyclophosphamide, and rituximab) regimen
    Induction: Cycle 1 - Rituximab 375 mg/m2 Day 1. Cycles 2-6 - Rituximab 500 mg/m2 Day 1. Cycles are 28-days in length. 2, 3, 6, 50

Therapy for relapsed or refractory CLL
  • With alemtuzumab (Campath®)
    See rituximab regimen under first-line therapy for CLL/SLL (above)
  • With chlorambucil
    See rituximab regimen under first-line therapy for CLL/SLL (above)
  • With lenalidomide
    Induction: Cycle 1 - Rituximab 375 mg/m2 weekly. Cycles 2-12 - Rituximab 375 mg/m2on Day 1. Cycles are 28 days. 50, 69
  • With fludarabine (FR)
    See rituximab regimen under first-line therapy for CLL/SLL (above)
  • FCR (fludarabine, cyclophosphamide, and rituximab) regimen2, 3, 6, 50
    See rituximab regimen under first-line therapy for CLL/SLL (above)
  • reduced-dose FCR50
    Induction: Cycle 1 - Rituximab 375 mg/m2 Day 1, then 500 mg/m2 Day 14. Cycles 2-6 - Rituximab 500 mg/m2 Days 1 and 14. 50
    Maintenance: Rituximab 500 mg/m2 Day 1 of a 3-month cycle until disease progression or unacceptable toxicity.50
  • With high-dose methylprednisolone
    See rituximab regimen under first-line therapy for CLL/SLL (above)
  • PCR (pentostatin, cyclophosphamide, and rituximab) regimen
    Induction: Cycles 2-6 only - Rituximab 375 mg/m2 Day 1 of 21-day cycle. 50
  • reduced-dose PCR (pentostatin, cyclophosphamide, and rituximab) regimen
    Induction: Cycle 1 - Rituximab 100 mg/m2 Day 1, then 375 mg/m2 Days 3 and 5. Cycles 2-6 - Rituximab 375 mg/m2 Day 1. Administer as a 21-day cycle for 6 cycles. 50
  • in combination with idelalisib (Zydelig®)
    Induction: Cycle 1 - Rituximab 375 mg/m2 on Day 1, then 500 mg/m2 on Day 15. Cycle 2 - Rituximab 500 mg/m2 on Days 1 and 15. Cycles 3-6 - Rituximab 500 mg/m2 on Day 1. 50, 91
  • in combination with venetoclax (Venclexta™)
    Induction: Cycle 1 - Rituximab 375 mg/m2 on Day 1. Cycles 2-6 - Rituximab 500 mg/m2 on Day 1. 33, 49

Initial therapy for histologic (Richter's) transformation to diffuse large B-cell lymphoma (clonally related or unknown clonal status) as a component of one of the following regimens:
  • RCHOPa
    Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 49
  • dose-adjusted EPOCHe
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 21-days in length. 49
  • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) with rituximab regimen alternating with high-dose methotrexate and cytarabine regimen
    Induction: Rituximab 375 mg/m2 on day 1 of a 21-day cycle. Alternate HyperCVAD cycles with high-dose methotrexate and cytarabine cycles (3 cycles of each for a total of 6 cycles).49, 78
  • OFAR (oxaliplatin, fludarabine, cytarabine, and rituximab) regimen
    Induction: Cycle 1 - Rituximab 375 mg/m2 on Day 3. Cycles 2-6 - Rituximab 375 mg/m2 on Day 1. Cycles are 28 days in length. 49, 114, 115
Lymphoma, Non-Hodgkin (NHL): Diffuse Large B-cell lymphoma 2, 3, 6First-line therapy as a component of one of the following regimens:
  • RCHOPa
    Induction: Rituximab 375 mg/m2 Day 1 for 3 cycles (Stage I-II) nonbulky disease (<7.5 cm) followed by radiation or 6 cycles (Stage I-II) nonbulky disease (<7.5 cm) or bulky disease (7.5 cm or more) with or without subsequent radiation or 6 cycles (Stage III-IV disease) with interim restaging after 2-4 cycles. Cycles are 21-days in length. Per prescribing information, a maximum of 8 infusions may be administered. 6, 50, 110
  • R-mini-CHOP
    Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycles for 6 cycles 6, 50, 96
  • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen
    Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycles for 6 cycles 50
  • RCEPP (rituximab, cyclophosphamide, etoposide, procarbazine, and prednisone)
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 28-days in length 50
  • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone)
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 21-days in length 50
  • dose-adjusted EPOCHe regimen with rituximab
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 21-days in length 6, 50
  • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone)
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 21-days in length 50

Second-line or subsequent therapy for relapsed or refractory disease as a single agent or as a component of the following regimens:
  • As a single agent
    Induction: Rituximab 375 mg/m2 weekly for 8 weeks 50
  • DHAPb
    Induction:
    Rituximab 375 mg/m2 Day 1 for 6-10 cycles. Cycles are 21- or 28-days in length50 or
    Rituximab 375 mg/m2 weekly for a total of 4 doses. Cycles are 21-days in length93 or
    Rituximab 375 mg/m2 on Day 5. Cycles repeat every 4 weeks for a total of 3 doses94 or
    Rituximab 375 mg/m2 on Day 1 for 4 cycles. Cycles are 21-days in length95, 106, 107
  • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen
    Induction: Rituximab 375 mg/m2 on Day 1. 50
  • ESHAPc
    Induction: Rituximab 375 mg/m2 Day 1 for 6-8 cycles. Cycles are 21- or 28-days in length. 50, 108
  • GDPg (gemcitabine, dexamethasone, and cisplatin)
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 21-days in length. 50
    or
    GDPg (gemcitabine, dexamethasone, and carboplatin)
    Induction: Rituximab 375 mg/m2 Day 1 for 4 cycles. Cycles are 21-days in length. 50
  • GemOX (gemcitabine and oxaliplatin)
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 14-days (NCCN-preferred) or 21-days in length.50
  • ICEd
    Induction:
    Rituximab 375 mg/m2 Day 1 for 3 cycles. Cycles are 14-days in length 50 or
    Rituximab 375 mg/m2 administered 48 hr before initiating the first-cycle, then on Day 1 of for 3 cycles (total of 4 doses). Cycles are 14-days in length.3, 109
  • MINEh
    Induction: Rituximab 375 mg/m2 Day 1 of Cycles 1-3, and Day 7 of Cycle 3. Cycles are 21-days in length. 50
  • In combination with bendamustine
    Induction: Rituximab 375 mg/m2 Day 1 (of a 21 day Cycle) for 6 cycles.50, 71, 72
  • In combination with lenalidomide
    Induction: Rituximab 375 mg/m2 Day 1 of a 28-day cycle until disease progression or unacceptable toxicity. 50
  • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine)
    See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
  • dose-adjusted EPOCHe
    See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
  • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone)
    See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)

First-line treatment of primary mediastinal large B-cell lymphoma as a component of one of the following regimens:
  • RCHOPa
    Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6-8 cycles with radiation 6, 50
  • dose-adjusted EPOCHe
    See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)

First-line treatment of grey zone lymphoma or First-line therapy for extracutaneous primary cutaneous diffuse large B-cell lymphoma, leg type as a component of one of the following regimens:
  • dose-adjusted EPOCHe
    See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
  • RCHOPa
    See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
  • Individuals with poor left ventricular function as a component of one of the following regimens:
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen for individuals greater than 80 years of age with comorbidities
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCEPP (rituximab, cyclophosphamide, etoposide, procarbazine, and prednisone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • dose-adjusted EPOCHe regimen with rituximab
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
  • For very frail individuals and individuals >80 years of age with comorbidities as a component of one of the following regimens:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • R-mini-CHOP
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)

First-line therapy for solitary regional, T1-2 (with involved site radiation therapy) or generalized cutaneous, T3 primary cutaneous diffuse large B-cell lymphoma, leg type as treatment for as a component of one of the following regimens:
  • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen
    See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
  • Individuals with poor left ventricular function as a component of one of the following regimens:
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone) regimen for individuals greater than 80 years of age with comorbidities
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCEPP (rituximab, cyclophosphamide, etoposide, procarbazine, and prednisone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • dose-adjusted EPOCHe regimen with rituximab
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
  • For very frail individuals and individuals >80 years of age with comorbidities as a component of one of the following regimens:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • R-mini-CHOP
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone)
      See rituximab regimen under first-line therapy for Diffuse Large B-cell lymphoma (above)

Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory primary cutaneous diffuse large B-cell lymphoma, leg type, with one of the following regimens:
  • as a component of one of the following regimens in individuals with intention to proceed to transplant
    • DHAPb
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • ESHAPc
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • GDPg
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • GemOX (gemcitabine and oxaliplatin)
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • ICEd
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • MINEh
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
  • as a component of one of the following regimens in individuals who are noncandidates for transplant
    • as a single agent
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • in combination with lenalidomide (non-germinal center lymphoma) or bendamustine
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • as a component of CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine)
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • as a component of dose-adjusted EPOCHe
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • as a component of CEOP (cyclophosphamide, etoposide, vincristine, and prednisone)
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • as a component of GDPg
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
    • as a component of GemOX
      See rituximab regimen under second-line or subsequent therapy for relapsed or refractory disease for Diffuse Large B-cell lymphoma (above)
Lymphoma, Non-Hodgkin (NHL): Follicular lymphoma
First-line therapy as a single agent when tolerability of combination therapy is a concern or in combination with chlorambucil or cyclophosphamide in elderly or infirm individuals with the indications for treatment* for one of the following:
  • without involved site radiation therapy for stage I (≥7 cm), contiguous stage II (≥7 cm), non-contiguous stage II disease
  • for individuals with indications for treatment* with stage III or IV disease

or

Second-line or subsequent therapy (NCCN-preferred) (if not previously given as first-line) in elderly or infirm individuals with refractory or progressive disease for individuals with indications for treatment*
  • with rituximab as a single agent
    • Induction: Rituximab 375 mg/m2 weekly for 4 weeks 50
  • in combination with chlorambucil
    • Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for one cycle.50
    • Consolidation: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 4 cycles.50
  • in combination with cyclophosphamide
    • Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.50

First-line therapy (NCCN-preferred) without involved site radiation therapy for stage I (≥7 cm), contiguous stage II (≥7 cm), non-contiguous stage II disease, or for individuals with indications for treatment* with stage III or IV disease as a component of one of the following regimens:
  • as a single agent in individuals that were initially observed and have progressed with a low tumor burden
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks 50
  • RCHOPa
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.2, 19, 50
  • RCVPf
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.50
  • bendamustine with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.2, 50
  • in combination with lenalidomide
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6-12 cycles. 50

First-line therapy for stage I, II pediatric-type follicular lymphoma in adults with extensive local disease who are not candidates for excision or involved site radiation therapy, as a component RCHOPa regimen
  • RCHOPa
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.50

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL
  • as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 4 or 8 weeks 2, 6, 50
    One-time Retreatment: Rituximab 375 mg/m2 weekly for 4 weeks 2, 6

Second-line or subsequent therapy for refractory or progressive disease:
  • as a single agent
    Induction:
    Rituximab 375 mg/m2 weekly for 4 weeks 50
    or
    Induction: Rituximab 375 mg/m2 weekly for 4 or 8 doses 6, 50
    Retreatment: Rituximab 375 mg/m2 weekly for 4 doses2, 6
  • bendamustine with rituximab
    See rituximab regimen under first-line therapy for Follicular lymphoma (above)
  • RCHOPa
    See rituximab regimen under first-line therapy for Follicular lymphoma (above)
  • RCVPf
    See rituximab regimen under first-line therapy for Follicular lymphoma (above)
  • gemcitabine and vinorelbine with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-days cycle for a maximum of 6 cycles. 50
  • Lenalidomide with rituximab
    Induction: Rituximab 375 mg/m2 weekly for 4 doses 50
  • For the following regimens, See rituximab regimen under second-line therapy for Diffuse large B-cell lymphoma
    • DHAPb regimen with rituximab
    • DHAX regimen with rituximab
    • ESHAPc regimen with rituximab
    • GDPg regimen with rituximab
    • GemOX (gemcitabine and oxaliplatin) regimen with rituximab
    • ICEd regimen with rituximab
    • MINEh regimen with rituximab
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen with rituximab
    • dose-adjusted EPOCHe regimen with rituximab
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen with rituximab

Treatment of histologic transformation to diffuse large B-cell lymphoma (DLBCL) without translocations of MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy as a component of:
  • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen
    Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 3 cycles (Stage I, II), nonbulky disease (<7.5cm) followed by radiation or 6 cycles (Stage I, II), nonbulky disease (<7.5cm) or bulky disease (7.5 cm or more) with or without subsequent radiation or 6 cycles (Stage III, IV) with interim restaging after 2-4 cycles. 50
  • dose-dense RCHOP-14
    Induction: Rituximab 375 mg/m2 Day 1 of a 14-day cycle for 3 cycles (Stage I, II), nonbulky disease (<7.5cm) followed by radiation or 4-6 cycles (Stage I, II), nonbulky disease (<7.5cm) or bulky disease (7.5 cm or more) with or without subsequent radiation or 6 cycles (Stage III, IV) with interim restaging after 2-4 cycles. 50
  • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) + rituximab regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50

Treatment of histologic transformation to DLBCL without translocations of MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy and have poor left ventricular function as a component of:
  • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.50
  • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50
  • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50
  • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50
  • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine and prednisolone) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50

Treatment of histologic transformation to DLBCL without translocations of MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy and are very frail and for individuals >80 years of age with comorbidities as a component of:
  • RCEPP regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.50
  • RCDOP regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50
  • R-mini-CHOP regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50
  • RGCVP regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50

Treatment of histologic transformation to diffuse large B-cell lymphoma (DLBCL) with translocations of MYC and BCL2 and/or BCL6 in individuals who have received minimal or no prior chemotherapy as a component of
  • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50
  • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles, alternating with high-dose methotrexate and cytarabine regimen with rituximab 50
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles, alternating with HyperCVAD with rituximab 50
  • R-CODOX-M (rituximab, cyclophosphamide, vincristine, and doxorubicin with methotrexate) regimen alternating with R-IVAC (rituximab, ifosfamide, etoposide, and cytarabine) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle (or when post-nadir ANC is 1000 cells/mm3 or greater) for 2 cycles (Cycle 1 and 3), alternating with IVAC + R. 50
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle (or when post-nadir ANC is 1000 cells/mm3 or greater) for 2 cycles (Cycle 2 and 4), alternating with R-CODOX-M + R. 50

Treatment of histologic transformation to diffuse large B-cell lymphoma in patients who have received multiple lines of chemoimmunotherapy for indolent or transformed disease in combination with:
  • as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 8 weeks 50
  • bendamustine
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.50
  • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.50
  • lenalidomide
    Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for 1 cycle.50
    Induction in non-germinal center B-cell like DLBCL-noncandidates for transplant: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle until disease progression or unacceptable toxicity. 50
  • gemcitabine and vinorelbine
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for a maximum of 6 cycles.50
  • For the following regimens, See rituximab regimen under second-line therapy for Diffuse large B-cell lymphoma
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen
    • DHAP (dexamethasone, cisplatin, and cytarabine) regimen
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen
    • ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) regimen
    • GemOX (gemcitabine and oxaliplatin) regimen
    • GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin) regimen
    • ICE (ifosfamide, carboplatin, and etoposide) regimen
    • MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen

First-line Consolidation therapy in individuals with the indications for treatment if initially treated with single-agent rituximab:

or

Maintenance therapy
  • as first-line consolidation or extended dosing for individuals initially presenting with high tumor burden (stage III,IV) who achieve a complete or partial response following treatment with RCHOP (rituximab, cyclophosphamide, doxorubicin, and prednisone) regimen or RCVP (rituximab, cyclophosphamide, vincristine and prednisone) regimen
  • second-line consolidation or extended dosing
  • Histologic transformation to diffuse large B-cell lymphoma that is coexisting with extensive follicular lymphoma who achieve a complete response to chemoimmunotherapy
    • as a single agent for First remission:
      • Induction: Rituximab 375 mg/m2 on Day 1. Repeat every 8 weeks for 2 years in individuals who present with high tumor burden, or 8 months for individuals initially treated with single-agent rituximab. 50
    • as a single agent for Second or Subsequent remission:
      • Induction: Rituximab 375 mg/m2 on Day 1. Repeat every 12 weeks for 2 years. 19, 50, 105
Lymphoma, Non-Hodgkin (NHL): Gastric MALT lymphomaInitial therapy (if radiation is contraindicated) as a single agent for individuals with H. pylori-negative stage I1, or I2, or stage II1 disease or for H. pylori-positive individuals with t(11,18) who following antibiotic therapy, are lymphoma positive after endoscopy for restaging
  • Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for 1 cycle.50

As a single agent (NCCN-preferred) or in combination with chlorambucil or cyclophosphamide in elderly or infirm individuals with indications for treatment** where tolerability of combination chemotherapy is a concern as:
  • first-line therapy for stage IIE, or II2, or stage IV (distant nodal, advanced stage) disease
  • additional therapy for stage I1, or I2, or stage II1 H. pylori positive disease if repeat endoscopy shows no response or recurrence after antibiotic therapy and involved site radiation therapy (ISRT)
  • additional therapy after ISRT or rituximab alone for stage I1, or I2, or stage II1 disease that is lymphoma positive after restaging with endoscopy
  • second-line or subsequent therapy for recurrent or progressive disease
    • as a single agent
      Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for 1 cycle.50
    • in combination with chlorambucil
      Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for 1 cycle.50
      Consolidation: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 4 cycles.50
    • in combination with cyclophosphamide
      Induction: Rituximab 375 mg/m2 on Days 1 of a 21- or 28-day cycle for 6-8 cycles.50

Individuals with indications for treatment** as a single agent (NCCN-preferred), or as a component of RCHOPa, RCVPf , or in combination with bendamustine
  • as first-line therapy for stage IIE, or II2, or stage IV disease (distant nodal, advanced stage)
  • as additional therapy for stage I1, or I2, or stage II1 H. pylori positive disease if repeat endoscopy shows no response or recurrence after antibiotic therapy and involved site radiation therapy (ISRT)
  • as additional therapy after ISRT or rituximab alone for stage I1, or I2, or stage II1 disease that is lymphoma positive after restaging with endoscopy
    • as a single agent
      Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for 1 cycle.50
    • RCHOPa
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.50
    • RCVPf
      Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.50
    • bendamustine with rituximab
      Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.50

Second-line or subsequent therapy for recurrent or progressive disease
  • as a single agent
    Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for 1-2 cycles 6, 50
    Retreatment: Rituximab 375 mg/m2 weekly for 4 doses2, 6
  • bendamustine with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.50
  • RCHOPa
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.50
  • RCVPf
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.50
  • lenalidomide with rituximab
    Induction: Rituximab 375 mg/m2 on Day 14 of a 28-day cycle for 6 cycles.50

Consolidation as optional first-line extended therapy in individuals initially treated with single agent therapy rituximab
    Consolidation: Rituximab 375 mg/m2 one dose every 12 weeks 49
Lymphoma, Non-Hodgkin (NHL): Hairy cell leukemia
Used in combination with cladribine or pentostatin for relapse or refractory disease
    Induction: Rituximab 375 mg/m2 weekly or every 2 week, given concurrently with cladribine or pentostatin. Maximum 8 doses.84, 85
    or
    Rituximab 375 mg/m2 weekly, beginning 1-2 months after the completion of pentostatin or cladribine treatment. Maximum 8 doses.84, 85, 86

Used in combination with vemurafenib for progression after therapy for relapsed/refractory disease
    Induction: Rituximab infusions 375 mg/m2 concomitantly with vemurafenib every 2 weeks, or sequentially (after the end of vemurafenib dosing) four times every 2 weeks. 163

As a single agent in individuals with the indication for treatment*** for individuals who are unable to receive purine analogs for one of the following:
  • less than complete response following initial treatment with cladribine or pentostatin
  • relapse within two years of complete response
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks82, 83
Histologic transformation of Marginal Zone Lymphoma to Diffuse Large B-cell Lymphoma Treatment of individuals who have received minimal or no prior chemotherapy as a component of one of the following:
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 3 cycles (Stage I, II), nonbulky disease (<7.5cm) followed by radiation or 6 cycles (Stage I, II), nonbulky disease (<7.5cm) or bulky disease (7.5 cm or more) with or without subsequent radiation or 6 cycles (Stage III, IV) with interim restaging after 2-4 cycles. 50
    • dose-dense RCHOP-14
      Induction: Rituximab 375 mg/m2 Day 1 of a 14-day cycle for 3 cycles (Stage I, II), nonbulky disease (<7.5cm) followed by radiation or 4-6 cycles (Stage I, II), nonbulky disease (<7.5cm) or bulky disease (7.5 cm or more) with or without subsequent radiation or 6 cycles (Stage III, IV) with interim restaging after 2-4 cycles. 50
    • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) + rituximab regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50

Treatment of individuals who have received minimal or no prior chemotherapy and have poor left ventricular function as a component of one of the following:
    • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 28-day cycle for 6 cycles. 50
    • RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, and prednisone) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 28-day cycle for 6 cycles. 50
    • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen with rituximab
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
    • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
    • RGCVP (rituximab, gemcitabine, cyclophosphamide, vincristine and prednisolone) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50

Treatment of individuals who have received minimal or no prior chemotherapy and are very frail and for individuals >80 years of age with comorbidities as a component of one of the following:
    • RCEPP regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 28-day cycle for 6 cycles. 50
    • RCDOP regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 28-day cycle for 6 cycles. 50
    • R-mini-CHOP regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
    • RGCVP regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50

Treatment for individuals who have received multiple lines of chemoimmunotherapy for indolent or transformed disease in one of the following:
    • as a single agent
      Induction: Rituximab 375 mg/m2 weekly for 8 weeks. 50
    • in combination with bendamustine
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
    • DHAP (dexamethasone, cytarabine, and cisplatin) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21- or 28-day cycle for 6-10 cycles. 50
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen50
      Induction: Rituximab 375 mg/m2 on Day 1. 50
    • ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21- or 28-day cycle for 6-8 cycles. 50
    • GDP (gemcitabine, dexamethasone, and cisplatin or gemcitabine, dexamethasone, and carboplatin) regimen
      Induction: GDP with cisplatin, administer rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
      Induction: GDP with carboplatin, administer rituximab 375 mg/m2 Day 1 of a 21-day cycle for 4 cycles. 50
    • GemOX (gemcitabine and oxaliplatin) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 14-day cycle (NCCN-preferred) or 21-day cycle for 6 cycles. 50
    • ICE (ifosfamide, carboplatin, and etoposide) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 14-day cycle for 3 cycles. 50
    • MINE (mesna, ifosfamide, mitoxantrone, and etoposide) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of Cycles 1-3. Rituximab 375 mg/m2 Day 7 of Cycle 3. Cycles are 21 days long. 50
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 28-day cycle for 6 cycles. 50
    • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
    • lenalidomide
      Induction: Rituximab 375 mg/m2 Day 1 of a 28-day cycle until disease progression or unacceptable toxicity. 50
    • gemcitabine and vinorelbine
      Induction: Rituximab 375 mg/m2 Day 1 of a 21-day cycle for 6 cycles. 50
Lymphoma, Non-Hodgkin (NHL): Mantle cell lymphomaNCCN-Preferred aggressive induction therapy for stage I-II disease that had a partial response, progression, or relapse after initial treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV TP53 mutation negative†† disease in individuals who are candidates for high-dose therapy/autologous stem cell rescue (HDT/ASCR) as a component of one of the following regimens:

†† Note: Per NCCN, aggressive induction therapy followed by HDT/ASCR may not be appropriate for TP53 positive disease. Optimal treatment is unknown.
  • HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine regimen with rituximab
    Induction: Cycles 1, 3, 5, 7: With Hyper-CVAD - Rituximab 375 mg/m2 on Day 1 administered every 21 days. Cycles 2, 4, 6, 8: With high-dose methotrexate and cytarabine - Rituximab 375 mg/m2 on Day 1 administered every 21 days2, 50, 74
  • NORDIC (dose-intensified induction immunochemotherapy with rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone [maxi-CHOP] alternating with rituximab and high-dose cytarabine) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of cycles 2-5, and Days 1 and 9 of cycle 6 50. Preemptive therapy may be given to prevent relapse: Rituximab 375 mg/m2 weekly for 4 weeks.75
  • alternating RCHOPa/RDHAP (rituximab, dexamethasone, cisplatin, and cytarabine) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles 50, 73
  • RDHA + platinum (rituximab, dexamethasone, cytarabine) + cisplatin, carboplatin, or oxaliplatin) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles 134

NCCN-Preferred less aggressive induction therapy for stage I-II disease as initial therapy (localized presentation, extremely rare), or for partial response, progression, or relapse after initial treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV TP53 mutation positive disease in individuals who are not candidates for high dose therapy/autologous stem cell rescue with one of the following regimens:
  • with bendamustine
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles .2, 50
  • VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 to 8 cycles 50
  • CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles 2, 3, 76, 104
  • lenalidomide
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 12 cycles 134
  • modified HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) regimen with rituximab in individuals older than 65 years
    Induction: Rituximab 375 mg/m2 on Day 1 starting on cycle 2. Cycles are 28-days in length. Administer for 4-6 cycles 2, 50

Consider single-agent maintenance therapy for aggressive stage II bulky, III, or IV disease symptomatic indolent stage II bulky, III, or IV disease following complete or partial response to induction therapy††† or high-dose therapy with autologous stem cell rescue (Note†††: Per NCCN, prospective trial data suggests no benefit of maintenance therapy after bendamustine + rituximab and maintenance therapy following VR-CAP [bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone] or RBAC [rituximab, bendamustine and cytarabine] therapy has not been tested)
    Maintenance: Rituximab 375 mg/m2 at week 12, month 5, month 7, and month 9 after completion of initial therapy2

Second-line therapy for stage I-II disease, aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV disease to achieve a complete response following partial response to induction therapy or for relapsed or progressive disease in one of the following regimens:
  • in combination with ibrutinib or lenalidomide (NCCN-preferred regimens) following a short response duration to prior chemoimmunotherapy (< expected median progression free survival (PFS)
    • Induction with lenalidomide: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of Cycle 1 only.
    • Induction and Consolidation with ibrutinib: Rituximab 375 mg/m2 once per week for 4 weeks during Cycle 1, then on Day 1 of Cycles 3-8, and thereafter once every other cycle up to 2 years. 49, 50, 186
  • in combination with ibrutinib following an extended response duration to prior chemoimmunotherapy (> expected median PFS)
    Induction and Consolidation with ibrutinib: Rituximab 375 mg/m2 once per week for 4 weeks during Cycle 1, then on Day 1 of Cycles 3-8, and thereafter once every other cycle up to 2 years. 49, 50, 186

Second-line therapy for stage I-II disease, aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV disease to achieve a complete response following partial response to induction therapy or for relapsed or progressive disease following an extended response duration to prior chemoimmunotherapy (> expected median progression free survival) in one of the following regimens:
  • as a single agent
    Induction: Rituximab 375 mg/m2 once every 8 weeks for a total of 4 doses.49, 117
  • in combination with bendamustine
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles 2, 50
  • in combination with bortezomib
    Induction: Cycles 2-5: Rituximab 375 mg/m2 on Days 1 and 8 of a 21-day cycle for a maximum of 5 cycles 80
    Maintenance: Rituximab 375 mg/m2 weekly for 4 doses. Repeat every 6 months for up to 2 years 80
  • as a component of:
    • gemcitabine, vinorelbine and rituximab regimen
      Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 21-days in length.135
    • DHAPb regimen with rituximab:
      Induction: Rituximab 375 mg/m2 weekly for a total of 4 doses. Cycles are 21-days in length93 or
      Rituximab 375 mg/m2 on Day 1 of a 21-day cycle. Maximum of 4 cycles. 106, 107
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen50
      Induction: Rituximab 375 mg/m2 on Day 1. 50
    • ESHAPc regimen with rituximab
      Induction: Rituximab 375 mg/m2 Day 1 for 6-8 cycles. Cycles are 21- or 28-days in length. 50, 108
    • GDPg regimen with rituximab
      See rituximab regimen under second-line therapy for Diffuse large B-cell lymphoma 101
    • GemOX (gemcitabine and oxaliplatin) regimen with rituximab
      Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 14- or 21-days in length.50, 102
    • ICEd regimen with rituximab
      Induction: Rituximab 375 mg/m2 Day 1 for 3 cycles. Cycles are 14-days in length. 50, 109
    • MINEh regimen with rituximab
      Induction: Rituximab 375 mg/m2 Day 1 of Cycles 1-3, and Day 7 of Cycle 3. Cycles are 21-days in length. 50
    • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen with rituximab
      Induction: Rituximab 375 mg/m2 Day 1 or Day 8 for 6 cycles. Cycles are 28-days in length 50
    • dose-adjusted EPOCHe regimen with rituximab
      Induction: Rituximab 375 mg/m2 on day 1 of a 21-day cycle, up to 6 cycles64
    • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen with rituximab
      See rituximab regimen under second-line therapy for Diffuse Large B-cell lymphoma (above)
Lymphoma, Non-Hodgkin (NHL):
Nodal Marginal Zone Lymphoma
First-line, second-line, or subsequent therapy as a single agent (NCCN-preferred) or in combination with chlorambucil or cyclophosphamide for stage I (≥7 cm), contiguous stage II (≥7 cm), non-contiguous stage II, or stage III, IV disease in elderly or infirm patients with indications for treatment in the setting of comorbidities where tolerability of combination chemotherapy is a concern
  • as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks 49
  • in combination with chlorambucil
    Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for one cycle.49, 50
    Consolidation: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 4 cycles.49, 50
  • in combination with cyclophosphamide with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28-day cycle for 6-8 cycles.49, 50

NCCN-Preferred first-line therapy for stage I (≥7 cm), contiguous stage II (≥7 cm), non-contiguous stage II, or stage III, IV disease in individual with indications for treatment in one of the following regimens:
  • RCHOPa
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.49, 50
  • RCVPf
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.49, 50
  • bendamustine with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.49, 50

Second-line or subsequent therapy for refractory or progressive disease in individuals with indications for treatment in one of the following regimens:
  • as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 4 or 8 doses 6, 50
    Retreatment: Rituximab 375 mg/m2 weekly for 4 doses2, 6
  • bendamustine with rituximab
    See rituximab regimen under second-line therapy for Follicular lymphoma
  • RCHOPa
    See rituximab regimen under second-line therapy for Follicular lymphoma
  • RCVPf
    See rituximab regimen under second-line therapy for Follicular lymphoma
  • lenalidomide with rituximab
    See rituximab regimen under second-line therapy for Diffuse large B-cell lymphoma

Consolidation as optional first-line extended therapy in individuals treated with single-agent rituximab
    Consolidation: Rituximab 375 mg/m2 one dose every 12 weeks 49
Lymphoma, Non-Hodgkin (NHL): Nongastric MALT lymphoma

First-line therapy for stage I-II disease in selected cases
  • Induction: Rituximab 375 mg/m2 weekly for 4 doses 49, 50

First-line, second-line, or subsequent therapy for stage IV disease or in recurrent stage I-II disease in elderly or infirm individuals where tolerability of combination chemotherapy is a concern, in one of the following regimens:
  • as a single agent
  • in combination with chlorambucil
  • in combination with cyclophosphamide
    See rituximab regimen under first-line therapy for Follicular lymphoma

First-line therapy (NCCN-preferred) for stage IV disease or recurrent stage I-II disease, as a component of one of the following regimens:
  • as a single agent
  • RCHOPa
  • RCVPf
  • bendamustine with rituximab
    See rituximab regimen under first-line therapy for Follicular lymphoma

Consolidation as first-line extended therapy in individuals initially treated with single agent rituximab
  • Consolidation: Rituximab 375 mg/m2 one dose every 12 weeks 49

Second-line or subsequent therapy for refractory or for progressive disease, in one of the following regimens:
  • For the following regimens, See rituximab regimen under second-line therapy for Follicular lymphoma:
    • as a single agent
    • bendamustine with rituximab
    • RCHOPa
    • RCVPf
  • As a component of lenalidomide with rituximab (See rituximab regimen under second-line therapy for Diffuse large B-cell lymphoma)
Lymphoma, Non-Hodgkin (NHL): Post-transplantation lymphoproliferative disorder (PTLD)Single-agent therapy as:
  • first-line therapy for monomorphic (B-cell type) or polymorphic (B-cell type) PTLD
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks. 50, 111
  • second-line therapy for partial response, persistent or progressive early lesions or for partial response, persistent or progressive monomorphic (B-cell type) PTLD if reduction of immunosuppressive was used as first-line therapy
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks. 50, 111
  • maintenance therapy for polymorphic (B-cell type) PTLD achieving complete response on first-line therapy
    Maintenance: Rituximab 375 mg/m2 on Day 1 of a 3-month cycle for 8 cycles (total of 2 years). 50, 119

Concurrent chemoimmunotherapy for CD20+ disease as a component of one of the following for frail individuals who cannot tolerate anthracyclines as first-line therapy for monomorphic (B-cell type) or systemic polymorphic (B-cell type) PTLD or as second-line therapy for persistent or progressive monomorphic (B-cell type) or polymorphic (B-cell type) PTLD
  • RCHOP-14
    Induction: Rituximab 375 mg/m2 on Day 1 of a 14-day cycle for 6 cycles 50
  • RCHOP-21
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle until maximal response, disease progression, or unacceptable toxicity (including reaching a lifetime cumulative anthracycle dose) for a maximum of 6 cycles 49, 50, 120, 121
  • RCVPf
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles 50
  • RCEPP (rituximab, cyclophosphamide, etoposide, prednisone, and procarbazine)
    Induction: Rituximab 375 mg/m2 on Day 1 or Day 8 of a 28-day cycle for 6 cycles 50
  • RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, and prednisone) regimen
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle until maximal response, disease progression, or unacceptable toxicity for a maximum of 6 cycles 50

Sequential chemoimmunotherapy as a single agent followed by CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen with or without rituximab as first-line therapy for monomorphic (B-cell type) or systemic polymorphic (B-cell type) PTLD
second-line therapy for partial response, persistent or progressive monomorphic (B-cell type) or polymorphic (B-cell type) PTLD
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks 50

Second-line and subsequent therapy for individuals with partial response, persistent or progressive disease after receiving chemoimmunotherapy as first-line treatment for monomorphic PTLD (B-cell type) in combination with:
  • as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 8 weeks 49, 50
  • bendamustine
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
  • DHAPb
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28-day cycle for 6-10 cycles.50, 106, 107
  • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen
    Induction: Rituximab 375 mg/m2 on Day 1. 50
  • ESHAPc
    Induction: Rituximab 375 mg/m2 Day 1 for 6-8 cycles. Cycles are 21- or 28-days in length.50, 108
  • GDPg
    Induction: with cisplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50, 101
    Induction: with carboplatin - Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 4 cycles. 50, 101
  • GemOX (gemcitabine and oxaliplatin) regimen
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 14-days (NCCN-preferred) or 21-days in length.50, 102
  • ICEd
    Induction: Rituximab 375 mg/m2 Day 1 for 3 cycles. Cycles are 14-days in length. 50, 109
  • MINEh
    Induction: Rituximab 375 mg/m2 Day 1 of Cycles 1-3, and Day 7 of Cycle 3. Cycles are 21-days in length. 50
  • CEPP (cyclophosphamide, etoposide, prednisone, and procarbazine) regimen
    Induction: Rituximab 375 mg/m2 Day 1 for 6 cycles. Cycles are 28-days in length 50
  • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) regimen
    Induction: Rituximab 375 mg/m2 on day 1 of a 21-day cycle, up to 6 cycles17, 58, 63, 64
  • CEOP (cyclophosphamide, etoposide, vincristine, and prednisone) regimen with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50, 101
  • lenalidomide
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle until disease progression or unacceptable toxicity. 50
  • gemcitabine and vinorelbine
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles. 50
Lymphoma, Non-Hodgkin (NHL):
Primary cutaneous B-cell lymphoma
Therapy for generalized disease (skin only), T3 primary cutaneous marginal zone or follicle center lymphoma, as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 4-8 weeks 17, 50
Lymphoma, Non-Hodgkin (NHL):
Splenic marginal zone lymphoma
Single-agent therapy (NCCN-Preferred) for symptomatic individuals with splenomegaly who are hepatitis C negative, hepatitis C positive with contraindications for hepatitis treatment, or hepatitis C positive with no response to appropriate hepatitis treatment
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks 50, 87

First-line, second-line or subsequent therapy therapy in elderly or infirm individuals upon disease progression following initial treatment for splenomegaly where tolerability of combination chemotherapy is a concern
  • as a single agent (NCCN-Preferred)
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks 49
  • chlorambucil with rituximab
    Induction: Rituximab 375 mg/m2 on Days 1, 8, 15, 22 of a 28-day cycle for one cycle.49, 50
    Consolidation: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 4 cycles.49, 50
  • cyclophosphamide with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21- or 28-day cycle for 6-8 cycles.49, 50

First-line therapy (NCCN-Preferred) for progressive disease following initial treatment for splenomegaly, as a component of one of the following:
  • as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 4 weeks 17, 49 or
    Rituximab 375 mg/m2 on Day 1 of each cycle for a maximum of 8 cycles6
  • RCHOPa
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.2, 49, 50
  • RCVPf
    Induction: Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6-8 cycles.2, 49, 50
  • bendamustine with rituximab
    Induction: Rituximab 375 mg/m2 on Day 1 of a 28-day cycle for 6 cycles.2, 49, 50

Consolidation as optional first-line extended therapy in individuals initially treated with single agent rituximab
  • Consolidation: Rituximab 375 mg/m2 one dose every 12 weeks 49

Second-line (if prior treatment with rituximab) or subsequent therapy for disease recurrence in individuals with the indications for treatment in one of the following regimens:
  • as a single agent
    Induction: Rituximab 375 mg/m2 weekly for 4 or 8 doses 6, 50
    Retreatment: Rituximab 375 mg/m2 weekly for 4 doses2, 6
  • bendamustine with rituximab
    See rituximab regimen under second-line therapy for Follicular lymphoma
  • RCHOPa
    See rituximab regimen under second-line therapy for Follicular lymphoma
  • RCVPf
    See rituximab regimen under second-line therapy for Follicular lymphoma
  • lenalidomide with rituximab
    See rituximab regimen under second-line therapy for Diffuse large B-cell lymphoma
Multiple sclerosis, relapsing-remitting
Induction: single dose of 500 or 1,000 mg 167, 168, 169

Maintenance: single dose of 500 or 1,000 mg administered every 6 months 167, 168, 169
Myasthenia gravis, refractory Induction: One of the following regimens:
  • 375 mg/m2 each week for 4 doses 3, 138
  • two-500 mg intravenous infusions separated by 2 weeks 3

Maintenance: One of the following regimens:
  • 375 mg/m2 each week for 4 doses, repeated every 6 months for 2-5 cycles 3
  • 375 mg/m2 once monthly, administered for up to 3 additional doses 3, 138

Retreatment: One of the following regimens:
  • 375 mg/m2 for one dose 138
  • 375 mg/m2 each week for 4 doses 138
  • two-500 mg intravenous infusions separated by 2 weeks 3
Nephrotic Syndrome, including Minimal Change Disease, in pediatric individuals
Induction: One of the following regimens: 68, 100, 103, 182, 183, 184
  • 375 mg/m2 (maximum dose: 500 mg) as a single dose
  • 375 mg/m2 once weekly for 2 to 4 doses

Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.

Retreatment: For cases of relapses, administer one of the following regimens: 63, 65
  • 375 mg/m2 as a single dose
  • 375 mg/m2 once weekly for 4 doses
Neuromyelitis optica (NMO)Induction: One of the following regimens:
  • 375 mg/m2 each week for 4 doses 138, 156, 158, 166
  • two-1000 mg intravenous infusions separated by 2 weeks 138, 156, 157, 158, 166

Consolidation: One of the following regimens:
  • 375 mg/m2 each week for 4 doses 166
  • 1000 mg infused only once 166
  • two-1000 mg intravenous infusions separated by 2 weeks 166

Maintenance: Repeat Induction dosing every 6 months or when CD19 cells counts are >0.1% of total lymphocytes 138, 156, 157, 158
Pemphigoid diseases refractory to corticosteroids or other immunosuppressive therapies
  • bullous pemphigoid
  • mucous membrane pemphigoid, including ocular cicatricial pemphigoid
  • epidermolysis bullosa acquisita
Induction: One of the following regimens:
  • 375 mg/m2 each week for 4 doses 146, 147, 148
  • 375 mg/m2 each week for 8 doses, in combination with IVIG 149
  • two-1000 mg intravenous infusions separated by 2 weeks 147

Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.

Retreatment: There is an absence of peer-reviewed evidence and clinical consensus regarding Retreatment therapy; therefore, dosing is not warranted.
Pemphigus diseases, first-line Induction: One of the following regimens:
  • 375 mg/m2 each week for 4 doses 144
  • 375 mg/m2 each week for 8 weeks, followed by 375 mg/m2 once monthly for 4 months 142
  • 500 mg once weekly for 4 doses 143
  • two-1000 mg intravenous infusions separated by 2 weeks. 6, 138, 144, 145 May be followed by 500 mg at Months 12 and 18 138, 145

Maintenance: One of the following regimens:
  • 500 mg administered at Month 12, and every 6 months thereafter 6
  • 1000 mg administered every 6 or 12 months 150

Retreatment: For cases of relapses, administer one of the following regimens (note: Subsequent infusions administered no sooner than 16 weeks following previous infusion):
  • 500 mg for 1 dose 144
  • 500 mg once weekly for 4 doses 143
  • 1000 mg for 1 dose 6
  • 1000 mg for 2 doses 144
Pemphigus diseases, refractory Induction: 375 mg/m2 each week for 4 weeks 2, 3, 7, 21, 27, 56, 138, 141 or two-1000 mg intravenous infusions separated by 2 weeks 21, 55, 88, 89, 138, 139, 140, 141

Maintenance: 375 mg/m2 once every 4 to 12 weeks21, 27, 56

Retreatment: For cases of relapses, or for individuals who did not achieve complete remission after Induction therapy, may administer one of the following regimens:
  • one cycle of 375 mg/m2 each week for 4 weeks 21, 138
  • two-1000 mg intravenous infusions separated by 2 weeks 21, 55, 56, 88, 89, 140
  • one 500 mg infusion administered six months after induction regimen, 139, 140 followed by one 500 mg infusion for relapses 139
Pemphigus vulgaris, refractory, with intravenous immune globulin Induction: Months 1 and 2: Rituximab 375 mg/m2 once weekly for 3 weeks, followed by intravenous immune globulin (IVIG) 2 g/kg on Week four. Months 3, 4, 5, and 6: At the start of each month, Rituximab 375 mg/m2 as a single infusion plus a single infusion of IVIG 2 g/kg136, 137

Maintenance: If clinically free of disease, continue IVIG for seven additional infusions136, 137
Pure red cell aplasia, refractory Induction: 375 mg/m2 once weekly for 4 doses10, 11, 153
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Rheumatoid arthritis, active 152 Induction: Two 1000 mg intravenous infusions separated by 2 weeks 2, 3, 6
Maintenance: Two subsequent courses with doses up to 1000 mg via intravenous infusion separated by 2 weeks should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. 2, 3, 6
Retreatment: For cases of relapses, one cycle of two-1000 mg intravenous infusions separated by 2 weeks may be administered 24 weeks after prior rituximab therapy.92
Scleroderma refractory to corticosteroids or other immunosuppressive therapies Induction: One of the following:
  • Two 1000 mg intravenous infusions separated by 2 weeks 164, 165, 171
  • 375 mg/m2 once weekly for 4 doses at baseline and at 24 weeks172

Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Sjogren’s syndrome (primary) refractory to corticosteroids and other immunosuppressive therapies Induction: Two 1000 mg intravenous infusions separated by 2 weeks 3, 161, 162, 170
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Thrombocytopenic purpura, immune or idiopathic (ITP) Induction: 375 mg/m2 once weekly for 4 doses2, 3, 12, 123, 151 or two 1000 mg intravenous infusions separated by 2 weeks 2, 123
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Thrombocytopenic purpura, thrombotic (TTP) Induction: 375 mg/m2 for a total of 4 doses (given weekly 2, 3, 122 or given on Days 0, 3, 7, 14 3)
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Transplantation, cardiac or renal
  • For prophylaxis
Induction: 375 mg/m2 as a single dose 38 or 1 g for 1-2 doses, 15 days apart 15, 39, 154 or up to 1 g weekly times 4 doses 37
Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Transplantation, cardiac or renal
  • For refractory antation antibody-mediated rejection (AMR)
Induction: One of the following regimens:
  • 375 mg/m2 once weekly for up to 4 doses 37, 40, 41, 42, 43, 155, 159
  • 500 mg as a single dose 44, 45, 155
  • 1,000 mg on days 7 and 21 or on days 7 and 22 159

Maintenance: There is an absence of peer-reviewed evidence and clinical consensus regarding Maintenance therapy; therefore, dosing is not warranted.
Waldenstrom's macroglobulinemia/ lymphoplasmacytic lymphoma
Used as a component of CaRD (carfilzomib, rituximab, dexamethasone):
  • as primary therapy49, 50, 98 or for relapse after 24 months if used as primary therapy49, 50
    • Induction: Rituximab 375 mg/m2 on Days 2 and 9 of a 21-day cycle for 6 cycles
    • Maintenance: Rituximab 375 mg/m2 on Day 2 administered every 8 weeks for 8 cycles, beginning 8 weeks after completion of induction

Primary therapy or as therapy for previously treated disease that does not respond to primary therapy, or for progressive or relapsed disease
  • As a single agent
    Induction: Rituximab 375 mg/m2 Day 1. Repeat weekly for 4 weeks, then may repeat 4 weekly doses after 3 months for a total of 8 doses. 49, 50
  • In combination with bortezomib without dexamethasone
    Induction: Cycles 1 and 4 - Rituximab 375 mg/m2 on Days 1, 8, 15, 22. Cycles are 28- or 35-days in length. (bortezomib administered for 6 cycles). 3, 16, 49, 50
    or
    Rituximab 375 mg/m2 on Day 1 of a 21-day cycle for 6 cycles.49, 50
  • In combination with bortezomib with dexamethasone
    Induction: Rituximab 375 mg/m2 on Day 11 of a 21-day cycle for 4 cycles. Additionally for primary therapy, starting 12 weeks after completion of the 4 cycles, administer Rituximab 375 mg/m2 on Day 1 of a 3-month cycle for 4 more cycles. 3, 49, 50
    or
    Induction: Cycles 2 and 5 - Rituximab 375 mg/m2 on Days 1, 8, 15, and 22. Total of 8 doses.2, 81
  • In combination with cyclophosphamide and prednisone
    Induction: Rituximab 375 mg/m2 Day 1. Repeat on a 28-day cycle for 6 cycles (primary therapy) or until maximal response, disease progression, or unacceptable toxicity (previously treated).49, 50
  • In combination with cyclophosphamide and dexamethasone
    Induction: Rituximab 375 mg/m2 Day 1. Repeat on a 21-day cycle for 6 cycles (primary therapy) or until maximal response, disease progression, or unacceptable toxicity (previously treated).3, 49, 50
  • RCHOPa
    Induction: Rituximab 375 mg/m2 Day 1. Repeat on a 21-day cycle until maximal response, disease progression, or unacceptable toxicity (including reaching a lifetime cumulative anthracycline dose) for a maximum of 6-8 cycles.49, 50
  • In combination with bendamustine
    Induction: Rituximab 375 mg/m2 on Day 1 or 2. Administer on a 28-day cycle, for 6 cycles (primary therapy) or until maximal response, disease progression, or unacceptable toxicity (previously treated). 49, 50, 99
  • In combination with cladribine
    Induction: Rituximab 375 mg/m2 Day 1. Administer on a 28-day cycle, for 2-4 cycles 3, 49, 50
  • In combination with fludarabine
    Induction: Rituximab 375 mg/m2 Day 1. Administer on a 28-day cycle, for 4-6 cycles. 49, 50
  • in combination with ibrutinib
    Induction: Rituximab 375 mg/m2 daily on Days 1, 8, 15, and 22 of Cycles 1 and 5 only. 50
  • As a component of FCR (fludarabine, cyclophosphamide, and rituximab)
    Induction: Rituximab 375 mg/m2 Day 1. Administer on a 28-day cycle, for 4-6 cycles.49, 50

Consider for maintenance therapy in individuals who achieve a complete, very good partial, partial, or minor response to primary therapy
    Maintenance: Rituximab 375 mg/m2 Day 1. Administer on a 3-month cycle for 2 years. 26, 49, 50
    or
    Rituximab 375 mg/m2 Day 1. Administer weekly for 4 weeks every 6 months for 2 years. 26, 49, 50


DOSING AND FREQUENCY REQUIREMENTS FOR RITUXIMAB AND HYALURONIDASE HUMAN (RITUXAN HYCELA™) FOR SUBCUTANEOUS INJECTION

Note: At least one full dose of rituximab (Rituxan®) infusion or related biosimilar (e.g., rituximab-abbs [Truxima®]) (i.e., Administered as Cycle 1) is required to be administered before treatment with rituximab and hyaluronidase human (Rituxan Hycela™) for subcutaneous injection.
Indication
Dosing and Frequency
Castleman's Disease (CD): Multicentric CD, Unicentric CD, or refractory or progressive disease As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Lymphoma, non-Hodgkin (NHL)
AIDS-related B-cell lymphoma As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Burkitt Lymphoma In combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 49, 125
Chronic Lymphocytic Leukemia (CLL)
  • With fludarabine, cyclophosphamide (FCR), for the treatment of previously untreated and previously treated CLL :
    • 1,600 mg/26,800 Units (rituximab/hyaluronidase human) subcutaneously on Day 1 of Cycles 2-6 (every 28 days) for a total of 5 cycles.124
  • FCR as first line therapy for disease without del(17p)/TP53 mutation for individuals less than 65 years of age without significant comorbidities :
    • 1,600 mg/26,800 Units (rituximab/hyaluronidase human) subcutaneously on Day 1 of Cycles 2-6 (every 28 days) for a total of 5 cycles.125
  • Relapsed or refractory disease without del(17p)/TP53 mutation in combination with one of the following regimens:
    • FCR regimen in individuals less than 65 years of age without significant comorbidities
      • 1,600 mg/26,800 Units (rituximab/hyaluronidase human) subcutaneously on Day 1 of Cycles 2-6 (every 28 days) for a total of 5 cycles.125
    • reduced-dose FCR regimen in individuals age 65 years and older, or younger individuals with significant comorbidities
      • Induction: 1,600 mg/26,800 Units (rituximab/hyaluronidase human) subcutaneously on Days 1 and 14 of Cycles 2-6 (every 28 days) for a total of 5 cycles.125
      • Maintenance: 1,600 mg/26,800 Units (rituximab/hyaluronidase human) subcutaneously on Day 1. Repeat every 3 months or until disease progerssion or unacceptable toxicity.125
Diffuse Large B-Cell Lymphoma (DLBCL) Previously untreated DLBCL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens:
    • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously on Day 1 of Cycles 2-8 for up to 7 cycles.124
As a single agent or in combination with other systemic therapies after individuals have received the first full dose of rituximab by intravenous infusion
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Follicular Lymphoma
  • Relapsed or refractory, follicular lymphoma as a single agent:
    • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously once weekly for 3 or 7 weeks.124
  • Retreatment for Relapsed or Refractory, Follicular Lymphoma as a single agent:
    • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously once weekly for 3 weeks.124
  • Previously untreated follicular lymphoma in combination with first line
chemotherapy and, in individuals achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy:
    • Induction: 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously on Day 1 of Cycles 2-8 (every 21 days) for up to 7 cycles.124
    • Maintenance: In those who achieve a complete or partial response, administer maintenance therapy 8 weeks after completion of rituximab/hyaluronidase human (Rituxan Hycela™) in combination with chemotherapy: 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously as a single agent every 8 weeks for 12 doses.124
  • Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy:
    • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously once weekly for 3 weeks administered at 6-month intervals. Maximum of 16 doses.124
  • Follicular Lymphoma Grade 1-2, as a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan)
    • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Gastric MALT Lymphoma As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Histologic transformation of Marginal Zone Lymphoma to Diffuse Large B-cell Lymphoma As a single agent or in combination with other systemic therapies (except ibritumomab tiuxetan)
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Mantle Cell Lymphoma As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Nodal Marginal Zone Lymphoma As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Nongastric MALT Lymphoma As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Post-antation lymphoproliferative disorder (PTLD) As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125
Primary Cutaneous B-Cell Lymphomas As therapy for generalized disease (skin only), T3 primary cutaneous marginal zone or follicle center lymphoma:
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously on Days 8, 15, and 22 for one 28-day cycle. 125
Splenic Marginal Zone Lymphoma As a single agent or in combination with other systemic therapies
  • 1,400 mg/23,400 Units (rituximab/hyaluronidase human) subcutaneously according to the schedule of the regimen, for a maximum of 6 cycles. 125

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Version Effective Date: 07/01/2019
Version Issued Date: 07/01/2019
Version Reissued Date: N/A

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