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Rituximab (intravenous) including biosimilars: Pediatric drug information

Rituximab (intravenous) including biosimilars: Pediatric drug information
(For additional information see "Rituximab (intravenous) including biosimilars: Drug information" and see "Rituximab (intravenous) including biosimilars: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Infusion-related reactions:

Rituximab administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue rituximab infusion for severe reactions and provide medical treatment for grade 3 or 4 infusion-related reactions.

Mucocutaneous reactions:

Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products.

Hepatitis B virus reactivation:

Hepatitis B virus (HBV) reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with rituximab. Discontinue rituximab and concomitant medications in the event of HBV reactivation.

Progressive multifocal leukoencephalopathy:

Progressive multifocal leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products.

Brand Names: US
  • Riabni;
  • Rituxan;
  • Ruxience;
  • Truxima
Brand Names: Canada
  • Riabni;
  • Rituxan;
  • Riximyo;
  • Ruxience;
  • Truxima
Therapeutic Category
  • Antineoplastic Agent, Anti-CD20;
  • Antineoplastic Agent, Monoclonal Antibody;
  • Antirheumatic Miscellaneous;
  • Immunosuppressant Agent;
  • Monoclonal Antibody
Dosing: Pediatric

Dosage guidance:

Safety: Prior to rituximab therapy, patients should be brought up to date with all nonlive vaccination if possible; any nonlive vaccines should be administered ≥4 weeks prior to first rituximab dose. Pretreatment with acetaminophen and an antihistamine (diphenhydramine typically used in pediatric trials) is recommended for all indications.

Dosage form information: In the United States, Riabni (rituximab-arrx), Ruxience (rituximab-pvvr), and Truxima (rituximab-abbs) are approved biosimilars to Rituxan (rituximab). In Canada, Riximyo, Ruxience, and Truxima are approved biosimilars to Rituxan (rituximab); refer to Canadian product monographs for biosimilar-specific labeled indications. Approved ages and uses may vary (consult product labeling).

Clinical considerations: For oncology uses, a uricostatic agent (eg, allopurinol) and aggressive hydration are recommended for patients at risk for tumor lysis syndrome (high tumor burden or lymphocytes >25,000/mm3) and dosing and frequency may vary by protocol and/or treatment phase; refer to specific protocol.

Acute lymphoblastic leukemia, mature B-cell, CD 20+; relapsed/refractory

Acute lymphoblastic leukemia, mature B-cell, CD 20+ (B-ALL); relapsed/refractory: Limited data available: Children ≥5 years and Adolescents: IV infusion: 375 mg/m2 administered on days 1 and 3 of courses 1 and 2 and on day 1 only of course 3; used in combination with ifosfamide, carboplatin, and etoposide (ICE) (Ref).

Autoimmune hemolytic anemia

Autoimmune hemolytic anemia: Limited data available: Infants ≥4 months, Children, and Adolescents: IV infusion: 375 mg/m2 once weekly for 4 doses (Ref).

Graft-versus-host disease, chronic, steroid refractory

Graft-versus-host disease, chronic (cGVHD), steroid refractory: Limited data available: Children and Adolescents: IV: 375 mg/m2 once weekly for 4 doses followed by monthly infusions has been reported; in preliminary data, GVHD musculoskeletal and dermal manifestations were observed to respond better than ophthalmic, hepatic, or gastrointestinal manifestations (Ref).

Granulomatosis with polyangiitis

Granulomatosis with polyangiitis (GPA, Wegener granulomatosis): Note: In addition to an antihistamine and acetaminophen, patients should also be premedicated 30 minutes prior to each infusion with methylprednisolone (eg, 100 mg IV in adults or equivalent). Patients should receive Pneumocystis jirovecii pneumonia (PCP) prophylaxis during rituximab therapy and for at least 6 months following the last rituximab dose.

Children ≥2 years and Adolescents:

Induction (active GPA): IV: 375 mg/m2 once weekly for 4 doses.

Note: Use rituximab in combination with corticosteroids (ie, methylprednisolone or oral corticosteroid taper). Prior to the first dose of rituximab, methylprednisolone should be administered for 3 days (30 mg/kg/dose once daily; maximum dose: 1,000 mg/dose) followed by oral corticosteroid taper per usual clinical practice and patient response.

Maintenance (once disease control achieved): IV: 250 mg/m2 every 2 weeks for 2 doses, followed by 250 mg/m2 every 6 months based upon clinical response. Begin maintenance regimen within 16 to 24 weeks of last rituximab induction dose. If rituximab was not part of induction regimen, begin rituximab within 4 weeks of achieving disease control.

Immune thrombocytopenic purpura, chronic

Immune thrombocytopenic purpura, chronic: Limited data available: Children and Adolescents: IV infusion: 375 mg/m2 once weekly for 4 doses (Ref).

Leukemia, acute B-cell; CD20+; advanced stage, previously untreated

Leukemia, acute B-cell; CD20+; advanced stage, previously untreated: Infants ≥6 months, Children, and Adolescents: IV infusion: 375 mg/m2/dose in combination with systemic Lymphome Malin B (LMB) chemotherapy regimen; administer 2 doses during each induction course (day −2 and day 1), and 1 dose on day 1 of each of the 2 consolidation cycles (6 doses total).

Microscopic polyangiitis

Microscopic polyangiitis (MPA): Note: In addition to an antihistamine and acetaminophen, patients should also be premedicated 30 minutes prior to each infusion with methylprednisolone (eg, 100 mg IV in adults or equivalent). Patients should receive PCP prophylaxis during rituximab therapy and for at least 6 months following the last rituximab dose.

Children ≥2 years and Adolescents:

Induction (active MPA): IV: 375 mg/m2 once weekly for 4 doses.

Note: Use rituximab in combination with corticosteroids (ie, methylprednisolone or oral corticosteroid taper). Prior to the first dose of rituximab, methylprednisolone should be administered for 3 days (30 mg/kg/dose once daily; maximum dose: 1,000 mg/dose) followed by oral corticosteroid taper per usual clinical practice and patient response.

Maintenance (once disease control achieved): IV: 250 mg/m2 every 2 weeks for 2 doses, followed by 250 mg/m2 every 6 months based upon clinical response. Begin maintenance regimen within 16 to 24 weeks of last rituximab induction dose. If rituximab was not part of induction regimen, begin rituximab within 4 weeks of achieving disease control.

Nephrotic syndrome, steroid-dependent

Nephrotic syndrome, steroid-dependent: Limited data available; use should be reserved for patients with frequent relapses despite optimal combinations of prednisone and corticosteroid-sparing therapy or intolerance to therapy (Ref). Children and Adolescents: IV infusion: 375 mg/m2 once weekly for 1 to 4 doses; a maximum dose of 500 mg/dose has been reported in some, but not all, reports; dosing based on small trials, case series, and retrospective analyses (Ref).

Non-Hodgkin lymphoma B-cell, CD 20+; relapsed and refractory

Non-Hodgkin lymphoma B-cell, CD 20+; relapsed and refractory: Limited data available: Children ≥11 years and Adolescents: IV infusion: 375 mg/m2 administered on days 1 and 3 of courses 1 and 2 and on day 1 only of course 3; used in combination with ICE (Ref).

Non-Hodgkin lymphoma; CD20+, diffuse large B-cell, Burkitt lymphoma, Burkitt-like lymphoma; previously untreated, advanced stage

Non -Hodgkin lymphoma; CD20+, diffuse large B-cell (DLBCL), Burkitt lymphoma, Burkitt-like lymphoma; previously untreated, advanced stage: Infants ≥6 months, Children, and Adolescents: IV infusion: 375 mg/m2/dose in combination with systemic Lymphome Malin B (LMB) chemotherapy regimen; administer 2 doses during each induction course (day −2 and day 1), and 1 dose on day 1 of each of the 2 consolidation cycles (6 doses total).

Posttransplant lymphoproliferative disorder

Posttransplant lymphoproliferative disorder: Limited data available: Infants ≥11 months, Children, and Adolescents: IV infusion: 375 mg/m2 once weekly for 3 to 4 doses (Ref).

Primary mediastinal large B-cell lymphoma

Primary mediastinal large B-cell lymphoma: Limited data available: Children and Adolescents: IV: 375 mg/m2 every 21 to 28 days for 6 to 8 doses; use in combination with multi-agent chemotherapy (Ref).

Systemic lupus erythematosus; refractory

Systemic lupus erythematosus; refractory: Limited data available; various dosing regimens reported in small open-labeled trials and case series; experts suggest rituximab as an option in nonresponders if more than one initial therapy has failed (Ref): Children ≥6 years and Adolescents: IV infusion: Usual regimen: Initial dose: 187.5 mg/m2 once (day 1) followed by 375 mg/m2 once weekly for 1 to 3 doses (days 8, 15, 22) (Ref); other reports omit the lower initial dose and administer 375 mg/m2 once weekly beginning on day 1 for 2 to 4 doses (days 8, 15, 22) (Ref). Others have reported a higher dose regimen of 750 mg/m2 on days 1 and 15 (maximum dose: 1,000 mg/dose) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Adult

(For additional information see "Rituximab (intravenous) including biosimilars: Drug information")

Dosage guidance:

Safety: Administer appropriate immunizations prior (eg, ≥4 weeks) to starting therapy (if possible) and screen for active or latent infections. Avoid use in patients with severe active infection. Prophylaxis against opportunistic infection and/or viral reactivation may be warranted during and up to 12 months after completion of rituximab therapy. Manufacturer's labeling recommends premedicating ~30 minutes prior to administration with acetaminophen, an antihistamine, and methylprednisolone 100 mg IV (or equivalent). For uses requiring concomitant administration with a glucocorticoid (eg, some oncology uses), administer glucocorticoid component of the chemotherapy regimen prior to rituximab infusion. Premedication practice may vary; refer to institutional protocols.

Dosage form information: In the United States, Riabni (rituximab-arrx), Ruxience (rituximab-pvvr), and Truxima (rituximab-abbs) are approved biosimilars to Rituxan (rituximab). In Canada, Riximyo, Ruxience, and Truxima are approved biosimilars to Rituxan (rituximab); refer to Canadian product monographs for biosimilar-specific labeled indications.

Acute lymphoblastic leukemia, B-cell precursor, CD20-positive

Acute lymphoblastic leukemia, B-cell precursor, CD20-positive (off-label use): Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

GRAALL 2005-R: Adults <60 years of age: IV: 375 mg/m2 on days 1 and 7 of induction (and days 1 and 7 of salvage cycle, if needed), on days 1 and 29 of consolidation 1 and 2, on days 1 and 7 of late intensification, on days 1 and 29 of consolidation 3, and on day 1 of reinductions 1, 3, 5, 7, 9, and 11 of the maintenance phase for a total of 16 to 18 rituximab doses. Note: Administer rituximab after hydration and before chemotherapy; administer rituximab after steroids, if both are administered on the same day. If the initial WBC is >30,000/mm3 on day 1 after the steroid prophase, split rituximab administration into 100 mg/m2 on days 1 and 2, followed by 175 mg/m2 on day 3 (total dose: 375 mg/m2). Refer to protocol for further information regarding concomitant chemotherapy agents, dosing, and administration (Ref).

Rituximab in combination with hyper-CVAD: Adults <60 years of age: IV: 375 mg/m2 on days 1 and 11 of hyper-CVAD cycles (cyclophosphamide, mesna, dexamethasone, doxorubicin, and vincristine) and on days 1 and 8 of high-dose methotrexate and cytarabine cycles, for a total of 8 rituximab doses over the first 4 courses; rituximab was also administered with early and late hyper-CVAD intensifications during months 6 and 18 of maintenance therapy (on days 1 and 11). Refer to protocol for further information regarding concomitant chemotherapy agents, dosing, and administration (Ref).

Antibody-mediated rejection, treatment

Antibody-mediated rejection, treatment (adjunctive agent) (off-label use):

Note: Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols. Administer as part of an appropriate combination regimen. If plasmapheresis is utilized, administer after completion of plasmapheresis (Ref).

Heart transplantation (off-label use): IV: 375 mg/m2 once weekly for 1 to 4 doses (Ref).

Kidney transplantation (off-label use): Note: For use in patients with evidence of microvascular inflammation on biopsy (Ref).

IV: 375 mg/m2 once weekly for 1 to 4 doses (Ref). Some experts administer a single dose of 200 to 375 mg/m2 (Ref).

Liver transplantation, treatment refractory (off-label use) : IV: 375 mg/m2 once weekly for 1 to 4 doses (Ref).

Lung transplantation (off-label use): IV: 375 mg/m2 once; may administer a second dose of 375 mg/m2 after ~2 weeks if donor-specific antibodies are still present (Ref).

Pancreas transplantation (off-label use): IV: 375 mg/m2 administered in 2-week intervals for a total of 1 to 4 doses (Ref).

Burkitt lymphoma

Burkitt lymphoma (off-label use): Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

IV: 375 mg/m2 on days 1 and 11 of cycles 1 and 3 and days 2 and 8 of cycles 2 and 4 (Ref) or 375 mg/m2 at the start of each chemotherapy cycle, followed by 2 additional doses 3 and 6 weeks after the completion of chemotherapy (Ref) or 50 mg/m2 on day 8 and 375 mg/m2 on days 10 and 12 of cycle 2 followed by 375 mg/m2 on day 8 of cycles 3 to 7 (Ref).

Chronic lymphocytic leukemia

Chronic lymphocytic leukemia: Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

Rituxan and rituximab biosimilars: IV: 375 mg/m2 on the day prior to fludarabine/cyclophosphamide in cycle 1, then 500 mg/m2 on day 1 (every 28 days) of cycles 2 to 6 (in combination with fludarabine and cyclophosphamide).

Off-label chronic lymphocytic leukemia combinations:

Previously untreated chronic lymphocytic leukemia (CLL): IV: 375 mg/m2 on the day prior to bendamustine in cycle 1, then 500 mg/m2 on day 1 (every 28 days) of cycles 2 to 6 (in combination with bendamustine) (Ref) or 375 mg/m2 on days 1 and 4 of cycle 1 (or 50 mg/m2 on day 1, followed by 325 mg/m2 on day 3, followed by 375 mg/m2 on day 5 of cycle 1), then 375 mg/m2 on day 1 (every 28 days) of cycles 2 to 6 (in combination with fludarabine; refer to protocol for rituximab dosing and infusion parameters) (Ref) or 50 mg/m2 on day 1 of cycle 2, followed by 325 mg/m2 on day 2 of cycle 2, followed by 500 mg/m2 on day 1 of cycles 3 to 7 (in combination with ibrutinib in patients <70 years of age with IGHV-unmutated CLL without 17p deletion) (Ref).

Relapsed or refractory chronic lymphocytic leukemia: IV: 375 mg/m2 on day 1, followed by 500 mg/m2 every 14 days for 4 doses and then 500 mg/m2 every 28 days for 3 doses (in combination with idelalisib) (Ref) or 375 mg/m2 on the day prior to bendamustine in cycle 1, then 500 mg/m2 on day 1 (every 28 days) of cycles 2 to 6 (in combination with bendamustine) (Ref) or 375 mg/m2 on day 1 of cycle 1, then 500 mg/m2 on day 1 (every 28 days) of cycles 2 to 6 (in combination with bendamustine and ibrutinib) (Ref) or 375 mg/m2 on day 1 of cycle 1 (following completion of dose ramp-up for venetoclax), then 500 mg/m2 on day 1 (every 28 days) of cycles 2 to 6 (in combination with venetoclax) (Ref).

Dermatomyositis/Polymyositis, refractory disease

Dermatomyositis and polymyositis, refractory disease (alternative agent) (off-label use):

Note: For use in patients who do not respond sufficiently to conventional induction regimens (eg, systemic glucocorticoids plus azathioprine or methotrexate). Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols.

IV: 1 g once every 2 weeks for 2 doses (Ref).

Eosinophilic granulomatosis with polyangiitis

Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (off-label use):

Note: For use in patients with severe disease (in combination with glucocorticoids) to initiate disease remission or to re-induce remission following relapse. May also be considered as alternative maintenance therapy in patients with severe disease (if remission was induced with rituximab) or in those who are unable to receive first-line therapies (Ref).

IV: 375 mg/m2 once weekly for 4 doses or 1 g once every 2 weeks for 2 doses (Ref).

Graft-versus-host disease, chronic, steroid refractory

Graft-versus-host disease, chronic, steroid refractory (off-label use): IV: 375 mg/m2 once weekly for 4 doses; a second course of 4 weekly doses may be administered 8 weeks after initial therapy for lack of or incomplete response (Ref) or 375 mg/m2 once weekly for 4 to 8 doses (Ref).

Granulomatosis with polyangiitis or microscopic polyangiitis

Granulomatosis with polyangiitis or microscopic polyangiitis (Rituxan and rituximab biosimilars):

Note: Optimal dose, frequency, and duration of therapy have not been established and vary based on disease severity, organ system(s) involved, and institutional protocols.

Induction therapy: Note: For use in patients with active, severe disease; may also be used to re-induce remission in patients with severe disease relapse or in patients with refractory disease. In patients with nonsevere disease, rituximab may be used as alternative induction therapy (Ref).

IV: 375 mg/m2 once weekly for 4 doses (manufacturer’s labeling) or 1 g once every 2 weeks for 2 doses (Ref); for either dosing regimen, administer in combination with a systemic glucocorticoid.

Maintenance therapy (after achieving disease control with induction): Note: For use in patients with severe disease, or as alternative to first-line agents in patients with nonsevere disease if remission was induced with rituximab or cyclophosphamide (Ref). If induction for active disease was with rituximab, begin rituximab maintenance therapy within 4 to 6 months of the last rituximab induction dose. If induction therapy was cyclophosphamide-based, begin rituximab maintenance therapy within 1 month following WBC recovery. Duration varies according to risk of relapse and may range from 6 months to indefinite use (Ref).

IV: 500 mg once every 2 weeks for 2 doses, then 500 mg or 1 g once every 4 to 6 months (Ref). Alternatively, some experts prefer to omit 500 mg once every 2 weeks for 2 doses and proceed with 500 mg or 1 g once every 4 to 6 months; other experts only re-dose intermittently with 500 mg or 1 g when peripheral CD19+ lymphocyte count reconstitutes and ANCA titers become positive (Ref).

Hairy cell leukemia

Hairy cell leukemia (off-label use): Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

In combination with cladribine (as initial treatment or after first relapse): IV: 375 mg/m2 once weekly (beginning 28 days ± 4 days after initiation of 5 days of cladribine) for 8 doses (Ref) or 375 mg/m2 once weekly (beginning concurrently with cladribine) for 8 doses (Ref).

In combination with vemurafenib (relapsed or refractory disease): IV: 375 mg/m2 on days 1 and 15 every 6 weeks (in combination with vemurafenib) for 2 induction cycles, followed by 375 mg/m2 once every 2 weeks for 4 rituximab monotherapy consolidation doses (total of 8 rituximab doses) (Ref).

Hodgkin lymphoma, nodular lymphocyte-predominate, advanced

Hodgkin lymphoma, nodular lymphocyte-predominate, advanced (off-label use): Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

IV: 375 mg/m2 once weekly for 4 weeks (Ref) or 375 mg/m2 once weekly for 4 weeks followed by maintenance dosing of 375 mg/m2 once weekly for 4 weeks every 6 months for 2 years (Ref). May be administered as a single agent or in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), or for relapsed disease, in combination with ifosfamide, carboplatin and etoposide (RICE) (Ref).

IgG4-related disease

IgG4-related disease (adjunctive agent) (off-label use):

Note: IgG4-related disease commonly presents as type 1 (IgG4-related) autoimmune pancreatitis; IgG4-related sclerosing cholangitis; major salivary gland enlargement or sclerosing sialadenitis; orbital disease, often with proptosis; and retroperitoneal fibrosis, frequently with chronic periaortitis. Consider for use in patients who have incomplete response to induction or are unable to sufficiently reduce glucocorticoid therapy (Ref).

IV: 1 g once every 15 days for 2 doses (Ref).

Immune thrombocytopenia

Immune thrombocytopenia (alternative agent) (off-label use):

Note: May be used as a single agent for patients who do not have an adequate platelet count response to glucocorticoids. Use in combination with other therapies has also been reported. Optimal dose, frequency, and duration have not been established and vary based on institutional protocols.

IV: 375 mg/m2 once weekly for 4 doses (Ref).

Kidney transplant, pretransplant desensitization

Kidney transplant, pretransplant desensitization (adjunctive) (off-label use):

Note: Several institutional protocols exist based on specific targets, anticipated transplant date, and goals of therapy; example regimens for ABO-compatible transplants are provided (Ref). Appropriate antiviral and antimicrobial prophylaxis should be employed during and following treatment (Ref).

IV: 1 g once administered 15 to 21 days prior to transplant; in combination with IVIG; with or without plasmapheresis (Ref).

Lupus nephritis, diffuse or focal, resistant

Lupus nephritis, diffuse or focal, resistant (off-label use):

Note: Consider for use in patients who are resistant to initial therapy (eg, glucocorticoids in combination with mycophenolate or cyclophosphamide). May use rituximab in combination with mycophenolate, a calcineurin inhibitor, or cyclophosphamide. Optimal dose, frequency, and duration of therapy are unknown and vary based on institutional protocols (Ref).

IV: 1 g on days 0 and 15 (Ref) or 375 mg/m2 once weekly for 4 doses (Ref).

Membranous nephropathy, primary

Membranous nephropathy, primary (off-label use):

Note: May be used in patients with normal kidney function who are at high or very high risk for progression and select moderate-risk patients (Ref). Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols.

IV: 1 g once every 2 weeks for 2 doses (Ref); alternative dosing regimens include 375 mg/m2 once weekly for 4 doses (Ref) or 375 mg/m2 once followed by a second dose of 375 mg/m2 if ≥5 circulating B cells per mcL are detected by flow cytometry 1 week after the initial dose (Ref).

Minimal change disease, frequently relapsing disease

Minimal change disease, frequently relapsing disease (alternative agent) (off-label use):

Note: For use in patients with frequently relapsing disease despite glucocorticoid therapy or who are glucocorticoid dependent. Initiate after remission is induced by glucocorticoids (Ref). Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols.

IV: 1 g once every 2 weeks for 2 doses; alternative regimens include 375 mg/m2 once weekly for 4 doses or 375 mg/m2 once followed by a second dose of 375 mg/m2 if ≥5 circulating B cells per mcL are detected by flow cytometry 1 week after the initial dose (Ref).

Mixed cryoglobulinemia syndrome, moderate to severe disease

Mixed cryoglobulinemia syndrome, moderate to severe disease (off-label use):

Note: Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols.

IV: 1 g once every 2 weeks for 2 doses (Ref) or 375 mg/m2 once weekly for 4 doses (Ref); usually administer in combination with a systemic glucocorticoid and, if due to HIV or hepatitis B virus infections, with antiviral therapy (Ref).

Mucosa-associated lymphoid tissue lymphoma, gastric, advanced

Mucosa-associated lymphoid tissue lymphoma, gastric, advanced (off-label use): Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

IV: 375 mg/m2 once weekly for 4 doses (Ref).

Multiple sclerosis

Multiple sclerosis (off-label use):

Note: Optimal dose, frequency, and duration of therapy have not been established. Dosing regimens vary based on institutional protocols.

IV: 1 g once every 2 weeks for 2 doses; then repeat 1 g once every 6 to 12 months (Ref). Alternatively, may administer 500 mg to 1 g once every 6 to 12 months (Ref).

Myasthenia gravis, refractory or muscle-specific tyrosine kinase antibody-positive

Myasthenia gravis, refractory or muscle-specific tyrosine kinase antibody-positive (off-label use):

Note: Recommended as an early option in patients with muscle-specific tyrosine kinase antibody-positive disease, or in refractory myasthenia gravis when response to other agents is insufficient or limited by toxicity (Ref). Optimal dose, frequency, and duration of therapy have not been established. Dosing regimens vary based on institutional protocols.

IV: 1 g once every 2 weeks for 2 doses or 375 mg/m2 once weekly for 4 weeks; may repeat full or partial course at preplanned intervals (eg, 6 months) or as clinically indicated based on symptoms and lymphocyte recovery (Ref).

Neuromyelitis optica, relapse prevention

Neuromyelitis optica, relapse prevention (alternative therapy) (off-label use):

Note: Optimal dose, frequency, and duration of therapy have not been established. Dosing regimens vary based on institutional protocols.

IV: 1 g once every 2 weeks for 2 doses or 375 mg/m2 once weekly for 4 weeks; then repeat 1 g once every 6 months or earlier if CD19+ lymphocytes become detectable (Ref).

Non-Hodgkin lymphomas

Non-Hodgkin lymphomas: Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

Diffuse large B-cell, previously untreated (Rituxan and rituximab biosimilars):

R-CHOP regimen: IV: 375 mg/m2 on day 1 of each chemotherapy cycle for up to 8 doses (in combination with CHOP chemotherapy [or other anthracycline-based regimen]). For patients ≤60 years of age with limited stage aggressive B-cell lymphoma and a favorable prognosis, a randomized trial demonstrated noninferiority with 4 cycles of rituximab-CHOP chemotherapy when compared to 6 cycles (Ref).

Pola-R-CHP regimen (off-label combination): IV: 375 mg/m2 on day 1 every 21 days (in combination with polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone) for 6 cycles, followed by rituximab monotherapy of 375 mg/m2 on day 1 of cycles 7 and 8 (Ref).

Diffuse large B-cell, relapsed or refractory (off-label combination): IV: 375 mg/m2 on day 1 of each 21-day chemotherapy cycle for up to 6 cycles (in combination with bendamustine and polatuzumab) (Ref).

Follicular, CD20-positive, B-cell, previously untreated (Rituxan and rituximab biosimilars): IV: 375 mg/m2 on day 1 of each chemotherapy cycle for up to 8 doses (in combination with first-line chemotherapy).

Maintenance therapy (as a single agent, in patients with partial or complete response to rituximab plus chemotherapy): Note: Begin 8 weeks after completion of rituximab in combination with chemotherapy. IV: 375 mg/m2 once every 8 weeks for 12 doses (Ref).

Nonprogressing, low-grade, CD20-positive, B-cell, after 6 to 8 cycles of first-line CVP are completed (Rituxan and rituximab biosimilars): IV: 375 mg/m2 once weekly for 4 doses every 6 months for a maximum of 16 doses (as a single agent).

Relapsed/Refractory, low-grade or follicular CD20-positive, B-cell (Rituxan and rituximab biosimilars): IV: 375 mg/m2 once weekly for 4 or 8 doses (as a single agent). Re-treatment following disease progression: 375 mg/m2 once weekly for 4 doses.

Follicular lymphoma, relapsed (single-agent therapy; off-label dosing): IV: 375 mg/m2 once weekly for 4 doses followed by 375 mg/m2 once every 2 months for 4 additional doses (Ref).

Follicular lymphoma, relapsed/refractory, maintenance therapy (as a single agent, in patients with response to induction therapy; off-label dosing): IV: 375 mg/m2 every 3 months until relapse or for maximum duration of 2 years (Ref).

Follicular lymphoma, relapsed/refractory (off-label combination): IV: 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1 (28-day cycle), followed by 375 mg/m2 on day 1 every 28 days of cycles 2 to 5 (in combination with lenalidomide) (Ref).

Rituxan and rituximab biosimilars: Combination therapy with ibritumomab: IV: 250 mg/m2 IV day 1; repeat in 7 to 9 days with ibritumomab (also see Ibritumomab monograph).

Splenic marginal zone lymphoma (off-label use): IV: 375 mg/m2 once weekly for 6 weeks followed by 375 mg/m2 once every 2 months for 1 to 2 years (Ref) or 375 mg/m2 once weekly for 4 weeks as monotherapy or 375 mg/m2 on day 1 of each chemotherapy cycle for up to 6 cycles; 1 to 2 additional cycles of rituximab monotherapy may be administered for consolidation or to improve response (Ref).

Pemphigus vulgaris or pemphigus foliaceus

Pemphigus vulgaris (labeled use [Rituxan only] for moderate to severe; off-label use for mild) or pemphigus foliaceus (off-label use for mild, moderate, or severe):

Note: Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols. May be used alone or as part of an appropriate combination regimen (eg, with systemic glucocorticoid) (Ref).

Initial dose: IV: 1 g once every 2 weeks for 2 doses, followed by a maintenance dose (Ref). For patients with complete remission who initially presented with severe disease or who have persistently elevated anti-desmoglein (Dsg) antibodies after 3 months, consider another dose of 500 mg to 1 g administered 6 months after initial therapy (Ref).

Maintenance dose (if complete remission is achieved with initial therapy): IV: 500 mg once 12 months after initial therapy, then every 6 months thereafter or based on clinical evaluation, but no sooner than every 16 weeks (Ref).

Treatment of relapse: Note: Consider in patients whose last rituximab dose was ≥4 to 6 months prior or in patients who did not previously receive rituximab as initial therapy (Ref).

IV: 1 g once every 2 weeks for 2 doses (Ref) or 1 g administered as a single dose (manufacturer's labeling).

Posttransplant lymphoproliferative disorder

Posttransplant lymphoproliferative disorder (off-label use):

Note: Used in monomorphic and polymorphic CD20+ disease in conjunction with reduction of immunosuppression. May be used as a single agent or in combination with chemotherapy and/or radiation (Ref). Optimal dose, frequency, and duration of therapy have not been established and vary based on type of lymphoproliferative disease and institutional protocols.

IV: 375 mg/m2 once weekly for 4 doses alone (Ref) or 375 mg/m2 once weekly for 4 doses followed 4 weeks later with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy (Ref).

Primary CNS lymphoma

Primary CNS lymphoma (off-label use):

Newly diagnosed: IV: 375 mg/m2 on day 3 every 14 days (in combination with high-dose methotrexate) until disease progression or unacceptable toxicity, or for 2 doses beyond a complete response followed by monthly treatments for up to a total of 1 year (Ref) or 500 mg/m2 on day 1 of each cycle for 5 to 7 induction cycles (in combination with high-dose methotrexate, vincristine, and procarbazine, followed by whole-brain radiotherapy and cytarabine consolidation) (Ref) or 375 mg/m2 once per week beginning on day 3 of remission induction and continuing for 6 doses (in combination with high-dose methotrexate, leucovorin, and temozolomide and followed by etoposide and cytarabine consolidation therapy) (Ref).

Refractory disease: IV: 375 mg/m2 on day 1 every 28 days (in combination with temozolomide) for 4 cycles, followed by temozolomide monotherapy (Ref).

Rheumatoid arthritis

Rheumatoid arthritis (Rituxan and rituximab biosimilars) (alternative agent):

Note: For use in patients who have not met treatment goals despite maximally tolerated methotrexate therapy, and either an inadequate response to TNF inhibitor therapy or a history of lymphoproliferative disorder for which rituximab is an approved therapy. May be administered in combination with methotrexate, another conventional synthetic disease-modifying antirheumatic drug, or as monotherapy if other treatment options are not tolerated (Ref). Patients should be under the care of a clinician experienced with use of rituximab for this condition.

IV: Initial: 1 g once every 2 weeks for 2 doses; subsequent courses of 1 g once every 2 weeks for 2 doses may be administered every 24 weeks or as indicated based on clinical evaluation, but no sooner than every 16 weeks. Note: In patients who initially respond, may consider a lower dose of 1 g once per subsequent course or 500 mg given twice (2 weeks apart) per course (Ref).

Thrombotic thrombocytopenic purpura, acquired

Thrombotic thrombocytopenic purpura, acquired (off-label use):

Note: Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols.

Acute treatment for initial therapy or for refractory or relapsing disease: IV: 375 mg/m2 once weekly for 4 doses, typically in combination with a systemic glucocorticoid and plasma exchange; administer immediately following plasma exchange and allow ≥24 hours after rituximab before the next plasma exchange (Ref).

Prophylactic therapy during remission (following treatment and recovery from an acute episode) with persistently low ADAMTS13 activity (eg, <20%) but normal platelet count: Note: The decision to treat prophylactically should be based on shared decision making to consider patient preferences regarding remission versus potential rituximab toxicity.

IV: 375 mg/m2 once weekly for 1 to 4 doses depending on follow-up measurements of ADAMTS13 activity (Ref). Some experts may administer a single dose of 375 mg/m2 approximately once every 3 months to maintain remission in patients with multiple relapses and severe ADAMTS13 deficiency (Ref).

Toxicities associated with immune checkpoint inhibitor therapy, treatment

Toxicities associated with immune checkpoint inhibitor therapy, treatment (alternative agent) (off-label use):

Note: For treatment of immune-mediated, corticosteroid-refractory dermatologic and hematologic immune mediated adverse events, as well as for immune-mediated encephalitis, myositis, or refractory myasthenia gravis (Ref).

IV: 375 mg/m2 once weekly for 4 doses (Ref).

Waldenström macroglobulinemia

Waldenström macroglobulinemia (off-label use): Note: Antihyperuricemic therapy and aggressive hydration are recommended for patients at high risk for tumor lysis syndrome (high tumor burden or lymphocytes ≥25,000/mm3).

In combination with cyclophosphamide and dexamethasone: IV: 375 mg/m2 on day 1 every 21 days for 6 cycles (Ref).

In combination with cyclophosphamide and fludarabine: IV: 375 mg/m2 on day 1 every 28 days for up to 6 cycles (Ref).

In combination with bortezomib: IV: 375 mg/m2 on days 1, 8, 15, and 22 every 28 days during cycles 1 and 4; treatment is continued for 6 cycles, with a total of 8 rituximab doses (Ref).

In combination with bortezomib and dexamethasone: IV: 375 mg/m2 on days 1, 8, 15, and 22 every 35 days during cycles 2 and 5; treatment is administered for 6 cycles, with a total of 8 rituximab doses (Ref) or 375 mg/m2 on day 11 every 21 days for 4 cycles (induction); after a 12-week break, 4 additional maintenance cycles (spaced 12 weeks apart) were administered (Ref).

In combination with bendamustine: IV: 375 mg/m2 on day 1 every 28 days for 4 cycles; single rituximab doses were also administered 1 week prior to the first cycle and 4 weeks after the last cycle (for a total of 6 rituximab doses) (Ref) or 375 mg/m2 on day 1 every 28 days for up to 6 cycles (Ref).

In combination with carfilzomib and dexamethasone: IV: 375 mg/m2 on days 2 and 9 every 21 days for 6 induction cycles, followed by 375 mg/m2 on day 2 every 8 weeks for 8 maintenance cycles (Ref).

In combination with ibrutinib: IV: 375 mg/m2 once weekly during weeks 1 to 4 and weeks 17 to 20 (Ref).

Warm autoimmune hemolytic anemia

Warm autoimmune hemolytic anemia (off-label use):

Note: Optimal dose, frequency, and duration of therapy have not been established and vary based on institutional protocols.

IV: 375 mg/m2 once weekly for 4 doses in combination with a systemic glucocorticoid (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Kidney impairment prior to treatment initiation:

Note: Theoretically, rituximab’s large molecular weight (145,000 Daltons) precludes the drug from being efficiently filtered at the glomerulus or by dialysis filters; hence, in general, dose adjustments for kidney dysfunction and/or renal replacement therapies should be unnecessary (Ref). In patients with nephrotic syndrome, urinary rituximab losses and altered pharmacokinetics have been observed, but the dosing implications of these findings are uncertain (Ref).

Altered kidney function: IV: No dosage adjustment necessary for any degree of kidney dysfunction (Ref).

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

IV: No dosage adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Not significantly dialyzed (Ref):

IV: No dosage adjustment or supplemental dose necessary (Ref).

Peritoneal dialysis: In general, unlikely to be significantly dialyzed (expert opinion); however, significant amounts reported to be dialyzed in a patient with nephrotic syndrome (Ref):

IV: No dosage adjustment necessary (Ref).

CRRT:

IV: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

IV: No dosage adjustment necessary (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations
Hepatitis B virus reactivation

Exacerbation of hepatitis B virus (HBV) may occur in patients treated with rituximab, in some cases resulting in fulminant hepatitis, hepatic failure, and death (Ref). Reactivation has occurred in patients who are hepatitis B surface antigen (HBsAg) positive (typical reactivation) as well as in those who are HBsAg negative but are anti-HBc positive (reverse seroconversion) (Ref).

Mechanism: In the immune system control of HBV infection, B-cells may act as antigen-presenting cells and prime cytotoxic T-cells for lysis of HBV-infected hepatocytes (Ref). Rituximab causes B-cell depletion (Ref), which therefore may impair control of HBV infection.

Onset: Delayed; may occur months to years after cessation of therapy (Ref).

Risk factors:

• Chronic HBV (HBsAg positive) or past HBV (HBsAg negative and anti-HBc positive with either negative or positive anti-HBs) infection (Ref)

• Hematologic malignancy (Ref)

• History of stem cell transplantation (Ref)

• Presence of other risk factor for HBV infection (eg, high-prevalence region, household contact, high-risk behavior) (Ref)

Hypogammaglobulinemia and Infection

Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab-based therapy (Ref). Infections have been reported in some patients with prolonged hypogammaglobulinemia. New or reactivated viral infections have included CMV viremia, herpes simplex infection, parvovirus B19 seroconversion, varicella zoster infection, West Nile virus, and hepatitis C and B.

Mechanism: Dose-related; immunosuppression due to B-cell depletion, hypogammaglobulinemia, and neutropenia (Ref).

Onset: Delayed; infection may occur at any time; risk may be higher in the 3 to 6 months after initiation (Ref).

Risk factors:

Hypogammaglobulinemia:

• More than 1 dose of rituximab (Ref)

• Maintenance regimens (Ref)

• Older age (Ref)

• Low pre-treatment immunoglobulin levels (Ref)

• Exposure to mycophenolate or purine analogues (Ref)

Infection:

• Malignant versus non-malignant indications (Ref)

• Higher number of rituximab courses (Ref)

• Prolonged low levels of IgG (Ref)

• G-CSF use (Ref)

• Glucocorticoid use (Ref)

• Chronic lung disease and/or cardiac insufficiency (Ref)

• Older patients (Ref)

• Extra-articular involvement in patients with rheumatic arthritis (Ref)

Infusion-related reactions

Serious (including fatal) infusion-related reactions have been reported with rituximab. Reactions may include angioedema, bronchospasm, cough, hypotension, hypoxia, throat irritation, urticaria, and in more severe cases, acute respiratory distress syndrome, pulmonary infiltrates, acute myocardial infarction, ventricular fibrillation, and cardiogenic shock (Ref).

Mechanism: Dose-related; may produce human antichimeric antibodies and human antihuman antibodies (Ref).

Onset: Rapid; usually occur within 30 to 120 minutes after starting the infusion.

Risk factors:

• First infusion (~80% of fatal infusion reactions occurred in association with the first infusion)

• Rapid infusion (Ref)

• High tumor burden with treatment-sensitive malignant disease (Ref)

• History of prior cardiopulmonary reactions

• Preexisting cardiac or pulmonary conditions

Progressive multifocal leukoencephalopathy (PML)

Progressive multifocal leukoencephalopathy (PML) due to John Cunningham (JC) virus infection has been reported with rituximab and may be fatal. Cases were reported in patients with hematologic malignancies receiving rituximab either with combination chemotherapy or with hematopoietic stem cell transplant. Cases were also reported in patients receiving rituximab for autoimmune diseases who had received concurrent or prior immunosuppressant therapy (Ref). Clinical findings included confusion/disorientation, motor weakness/hemiparesis, altered vision/speech, and poor motor coordination with symptoms progressing over weeks to months (Ref).

Mechanism: Non–dose-related; reactivation of the JC virus (Ref).

Onset: Delayed; most cases were diagnosed within 12 months of the last rituximab dose. A retrospective analysis of patients (n=57) diagnosed with PML following rituximab therapy found a median of 16 months (following rituximab initiation), 5.5 months (following last rituximab dose), and six rituximab doses preceded PML diagnosis (Ref). In a series of rheumatologic cases, a median of 12 months (range 1 to 57 months following rituximab initiation), and 5 months (range 0 to 29 months following last rituximab dose), and two rituximab courses preceded PML diagnosis (Ref).

Risk factors:

• Systemic lupus erythematosus (SLE) (Ref)

• Undiagnosed HIV (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Patients treated with rituximab for rheumatoid arthritis (RA) may experience fewer adverse reactions. Most reported adverse reactions are from studies in which rituximab was given concomitantly with chemotherapeutic agents, glucocorticoid steroids, or methotrexate. Reported adverse reactions are for adults.

>10%:

Cardiovascular: Cardiac disorder (5% to 29%), flushing (5% to 14%), hypertension (6% to 12%) (table 1), peripheral edema (8% to 16%)

Rituximab: Adverse Reaction: Hypertension

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

12%

Cyclophosphamide plus glucocorticoids: 5%

375 mg/m² once weekly for 4 weeks

Granulomatosis with polyangiitis and microscopic polyangiitis; induction therapy

99

98

Rituximab plus glucocorticoids

6%

N/A

Most patients received 375 mg/m² weekly for 4 doses

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin lymphoma

356

N/A

N/A

8%

Placebo plus methotrexate: 5%

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate

Dermatologic: Night sweats (15%), pruritus (≤17%) (table 2), skin rash (≤17%) (table 3)

Rituximab: Adverse Reaction: Pruritus

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

17%

No further therapy: 5%

375 mg/m² once weekly for 4 doses every 6 months for up to 16 doses

Previously untreated, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma, maintenance therapy

N/A

N/A

In patients who did not progress after 6 to 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP); described as "rash and/or pruritus"

10%

Cyclophosphamide, vincristine, prednisone (CVP): 1%

N/A

Previously untreated, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

N/A

N/A

Rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP)

14%

N/A

Most patients received 375 mg/m2 weekly for 4 doses

Relapsed or refractory, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

356

N/A

N/A

5%

Placebo plus methotrexate: 1%

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate

Rituximab: Adverse Reaction: Skin Rash

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

10%

Cyclophosphamide plus glucocorticoids: 17%

375 mg/m² once weekly for 4 weeks

Granulomatosis with polyangiitis and microscopic polyangiitis; induction therapy

99

98

Rituximab plus glucocorticoids

17%

Cyclophosphamide, vincristine, and prednisone (CVP): 5%

N/A

Previously untreated, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

N/A

N/A

Rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP)

17%

No further therapy: 5%

375 mg/m² once weekly for 4 doses every 6 months for up to 16 doses

Previously untreated, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

N/A

N/A

In patients who did not progress after 6 to 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP); described as "rash and/or pruritus"

15%

N/A

Most patients received 375 mg/m² weekly for 4 doses

Relapsed or refractory, low-grade or follicular, CD-20 positive, B-cell non-Hodgkin lymphoma

356

N/A

N/A

Endocrine & metabolic: Hypophosphatemia (12% to 21%), weight gain (11%)

Gastrointestinal: Abdominal pain (14%), diarrhea (10% to 17% grades 3/4: 1%), nausea (8% to 23%; grades 3/4: 1%)

Hematologic & oncologic: Anemia (8% to 35%; grades 3/4: 3%), febrile neutropenia (grades 3/4: 9% to 15%), hypogammaglobulinemia (<1% to 58%; including IgA, IgG, or IgM below the lower limit of normal, can be prolonged) (table 4), leukopenia (10% to 14%; grades 3/4: 4% to 23%), lymphocytopenia (48%; grades 3/4: 40%), neutropenia (8% to 14%; grades 3/4: 4% to 49%; may be prolonged neutropenia [lasting up to 42 days] or late onset [occurring >42 days after last dose]), thrombocytopenia (12%; grades 3/4: 2% to 11%)

Rituximab: Adverse Reaction: Hypogammaglobulinemia

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

58%

Cyclophosphamide plus glucocorticoids: 50%

375 mg/m² once weekly for 4 weeks

Granulomatosis with polyangiitis and microscopic polyangiitis; induction therapy

99

98

Rituximab plus glucocorticoids; Low IgG level

51%

Cyclophosphamide plus glucocorticoids: 46%

375 mg/m² once weekly for 4 weeks

Granulomatosis with polyangiitis and microscopic polyangiitis; induction therapy

99

98

Rituximab plus glucocorticoids; Low IgM level

27%

Cyclophosphamide plus glucocorticoids: 25%

375 mg/m² once weekly for 4 weeks

Granulomatosis with polyangiitis and microscopic polyangiitis; induction therapy

99

98

Rituximab plus glucocorticoids; Low IgA level

16%

Mycophenolate mofetil (MMF) plus oral corticosteroids: N/A

1,000 mg on days 1, 15, week 24, and week 26 for up to 52 weeks

Pemphigus vulgaris

67

N/A

Rituximab plus oral corticosteroids; prolonged hypogammaglobulinemia (defined as Ig levels below lower limit of normal for at least 4 months); IgG or IgM

10%

Placebo plus methotrexate: N/A

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate; Low IgM level

3%

Placebo plus methotrexate: N/A

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate; Low IgG level

0.8%

Placebo plus methotrexate: N/A

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate; Low IgA level

Hepatic: Hepatobiliary disease (17%), increased serum alanine aminotransferase (13%)

Hypersensitivity: Angioedema (11%)

Immunologic: Antibody development (1% to 32%)

Infection: Bacterial infection (19%; including cellulitis), infection (19% to 63%%; including CMV viremia, herpes simplex infection, parvovirus B19 seroconversion, varicella zoster infection, hepatitis C, and lower respiratory tract infection) (table 5), serious infection (2% to 11%; including sepsis)

Rituximab: Adverse Reaction: Infection

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

62%

Cyclophosphamide plus glucocorticoids: 47%

375 mg/m² once weekly for 4 weeks

Granulomatosis with polyangiitis and microscopic polyangiitis; induction therapy

99

98

Rituximab plus glucocorticoids

63%

Mycophenolate mofetil (MMF) plus oral corticosteroids: N/A

1,000 mg on days 1, 15, week 24, and week 26 for up to 52 weeks

Pemphigus vulgaris

67

N/A

Rituximab plus oral corticosteroids

37%

Observation: 22%

375 mg/m² once weekly for 8 weeks for up to 12 doses

Previously untreated, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma; maintenance therapy

N/A

N/A

Initiated 8 weeks following completion of chemotherapy in patients who achieved a response with rituximab plus chemotherapy

19%

No further therapy: 9%

375 mg/m² once weekly for 4 doses every 6 months for up to 16 doses

Previously untreated, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma; maintenance therapy

N/A

N/A

In patients who did not progress after 6 to 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP)

31%

N/A

Most patients received 375 mg/m² weekly for 4 doses

Relapsed or refractory, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

356

N/A

N/A

39%

Placebo plus methotrexate: 34%

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate

Nervous system: Chills (3% to 33%), fatigue (13% to 39%), headache (15% to 19%), insomnia (14%), pain (12%), peripheral sensory neuropathy (30%)

Neuromuscular & skeletal: Arthralgia (6% to 13%), asthenia (2% to 26%), muscle spasm (17%)

Respiratory: Bronchitis, cough (13% to 15%) (table 6), epistaxis (11%), nasopharyngitis (≤16%), pulmonary disease (31%), pulmonary toxicity (18%), rhinitis (3% to 12%), upper respiratory tract infection (≤16%)

Rituximab: Adverse Reaction: Cough

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

13%

Cyclophosphamide plus glucocorticoids: 11%

375 mg/m² once weekly for 4 weeks

Granulomatosis with polyangiitis and microscopic polyangiitis; induction therapy

99

98

Rituximab plus glucocorticoids

15%

Cyclophosphamide, vincristine, and prednisone (CVP): 6%

N/A

Previously untreated, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin lymphoma

N/A

N/A

Rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP)

13%

N/A

Most patients received 375 mg/m² weekly for 4 doses

Relapsed or refractory, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

356

N/A

N/A

Miscellaneous: Fever (5% to 56%), infusion related reaction (first dose: 12% to 77%; including cytokine release syndrome and nonimmune anaphylaxis; reactions can be acute; decreases with subsequent infusions) (table 7)

1% to 10%:

Cardiovascular: Chest tightness (7%), hypotension (10%), significant cardiovascular event (2%)

Dermatologic: Urticaria (2% to 8%) (table 8)

Rituximab: Adverse Reaction: Urticaria

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

8%

N/A

Most patients received 375 mg/m² weekly for 4 doses

Relapsed or refractory, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

356

N/A

N/A

2%

Placebo plus methotrexate: <1%

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate

Endocrine & metabolic: Hyperglycemia (9%), hyperuricemia (2%), increased lactate dehydrogenase (7%)

Gastrointestinal: Dyspepsia (3%), oral candidiasis (9%), upper abdominal pain (2%), vomiting (10%; grades 3/4: 1%)

Genitourinary: Urinary tract infection (8%)

Hematologic & oncologic: Pancytopenia (grades 3/4: 3%; can be prolonged)

Hepatic: Exacerbation of hepatitis B (grades 3/4: 2%)

Infection: Fungal infection (1%), viral infection (10%; including herpes zoster)

Nervous system: Anxiety (2% to 5%), dizziness (6% to 10%), migraine (2%), paresthesia (2%), rigors (10%)

Neuromuscular & skeletal: Back pain (9% to 10%), myalgia (10%)

Respiratory: Bronchospasm (8%), dyspnea (7% to 10%), sinusitis (6%), throat irritation (2% to 9%) (table 9)

Rituximab: Adverse Reaction: Throat Irritation

Drug (Rituximab)

Comparator

Dose

Indication

Number of Patients (Rituximab)

Number of Patients (Comparator)

Comments

9%

N/A

Most patients received 375 mg/m² weekly for 4 doses

Relapsed or refractory, low-grade or follicular, CD-20 positive, B-cell, non-Hodgkin lymphoma

356

N/A

N/A

2%

Placebo plus methotrexate: 0%

2 x 1,000 mg

Rheumatoid arthritis

540

398

Rituximab plus methotrexate

<1%: Hematologic & oncologic: Hemolytic anemia, pure red cell aplasia

Postmarketing:

Cardiovascular: Acute myocardial infarction (Kasi 2012), cardiac tamponade (Cohen 2006), cardiogenic shock (Kasi 2012), heart failure (Kasi 2012), Kawasaki syndrome (Sato 2020), myocarditis (Ghielmini 2004), vasculitis (systemic; with rash) (Kim 2009), ventricular fibrillation (Kasi 2012), ventricular tachycardia (Kasi 2012),

Dermatologic: Epidermolysis bullosa (Wu 2020), lichenoid dermatitis (Scheinfeld 2006), pemphigus (paraneoplastic) (Scheinfeld 2006), pyoderma gangrenosum (including genital presentation) (Georgakopoulos 2018, Maloney 2018), Stevens-Johnson syndrome (Scheinfeld 2006), toxic epidermal necrolysis (Scheinfeld 2006), vesiculobullous dermatitis (Scheinfeld 2006)

Gastrointestinal: Crohn’s disease (Cavalcanti 2020), enterocolitis (including ileocolitis, ulcerative colitis, microscopic colitis) (Tsuzuki 2021), intestinal obstruction (Kasi 2012), intestinal perforation (mean onset: 6 days [range: 1 to 77 days in patients with non-Hodgkin lymphoma]) (Cornejo 2009, Kollmar 2002)

Hematologic & oncologic: Bone marrow depression (Kasi 2012), increased serum immunoglobulins (hyperviscosity syndrome in Waldenström's macroglobulinemia), Kaposi sarcoma (including new onset and progression) (Billon 2018, Geller 2018), sarcoidosis (children: Scar sarcoidosis) (Vesely 2020), tumor lysis syndrome (Yang 1999)

Hepatic: Fulminant hepatitis (Evens 2011), hepatic failure (Evens 2011)

Hypersensitivity: Anaphylaxis (Liccioli 2020), serum sickness (Fouda 2020)

Infection: Reactivation of HBV (Evens 2011)

Nervous system: Progressive multifocal leukoencephalopathy (Carson 2009, Molloy 2012), reversible posterior leukoencephalopathy syndrome (Mustafa 2019)

Neuromuscular & skeletal: Arthritis (polyarticular), lupus-like syndrome (Chessa 2021)

Ophthalmic: Optic neuritis, uveitis

Renal: Nephrotoxicity

Respiratory: Acute respiratory distress syndrome (Kasi 2012), bronchiolitis obliterans (Shen 2012), hypoxia (Kasi 2012), interstitial pulmonary disease (Wagner 2007), pleurisy, pneumonia, pulmonary infiltrates (Kasi 2012)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Known type 1 hypersensitivity or anaphylactic reaction to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or any component of the formulation; patients who have or have had progressive multifocal leukoencephalopathy (PML); patients with severe, active infections

Warnings/Precautions

Concerns related to adverse effects:

• Bowel obstruction/perforation: Abdominal pain, bowel obstruction, and perforation have been reported (rarely fatal), with an average onset of symptoms of ~6 days (range: 1 to 77 days); evaluate abdominal pain or repeated vomiting.

• Cytopenias: Rituximab is associated with lymphopenia, leukopenia, neutropenia, thrombocytopenia, and anemia; the duration of cytopenias may be prolonged and may extend months beyond treatment.

• Renal toxicity: May cause fatal renal toxicity in patients with non-Hodgkin lymphomas (NHL). Patients who received combination therapy with cisplatin and rituximab for NHL experienced renal toxicity during clinical trials; this combination is not an approved treatment regimen. Renal toxicity also occurred due to tumor lysis syndrome.

• Tumor lysis syndrome: Tumor lysis syndrome leading to acute renal failure requiring dialysis (sometimes fatal) may occur within 12 to 24 hours following the first dose when used as a single agent in the treatment of NHL. Hyperkalemia, hypocalcemia, hyperuricemia, and/or hyperphosphatemia may occur. Administer prophylaxis (antihyperuricemic therapy, aggressive hydration) in patients at high risk (high numbers of circulating malignant cells ≥25,000/mm3 or high tumor burden). Correct electrolyte abnormalities and administer supportive care as indicated.

Special populations:

• Granulomatosis with polyangiitis/microscopic polyangiitis: The safety of concomitant immunosuppressants other than corticosteroids has not been evaluated in patients with granulomatosis with polyangiitis or microscopic polyangiitis after rituximab-induced B-cell depletion.

• Older adult: There is a higher risk of cardiac (supraventricular arrhythmia) and pulmonary adverse events (pneumonia, pneumonitis), and the incidence of grade 3 or 4 adverse reactions are higher in patients ≥65 years of age.

• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold biologic disease-modifying antirheumatic drugs (DMARDs) prior to surgery and plan surgery after the next dose is due. Surgery can occur after holding medication for 1 full dosing cycle (eg, for medications administered every 4 weeks, schedule surgery 5 weeks from last administered dose); therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk). Decisions to withhold therapy should be based on shared decision making; ensure the patient and their provider weigh risks of interrupting therapy and disease control versus risks of continuing therapy and surgical complications (ACR/AAHKS [Goodman 2022]).

• Pemphigus vulgaris: The safety of concomitant immunosuppressants other than corticosteroids has not been evaluated in patients with pemphigus vulgaris after rituximab-induced B-cell depletion.

• Rheumatoid arthritis: There are limited data on the safety of other biologics or DMARDs other than methotrexate in patients with rheumatoid arthritis (RA) with B-cell depletion following rituximab treatment. Monitor patients closely for infection if biologic agents or DMARDs are used concomitantly. The use of rituximab is not recommended in RA patients who have not had prior inadequate response to one or more tumor necrosis factor antagonists.

Dosage form specific issues:

• Administration: Rituximab is for IV administration only. Do not substitute rituximab and hyaluronidase (SUBQ) for rituximab (IV). Use caution during product selection, preparation, and administration.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Immunizations: In the oncology setting, live vaccines should not be given before or during rituximab treatment; the safety of live vaccines following rituximab treatment has not been studied. When using for the treatment of multiple sclerosis, avoid live-attenuated vaccines in patients who currently receive or have recently discontinued rituximab; consider using live-attenuated vaccines only if risk of infection is high and killed vaccines are unavailable (AAN [Farez 2019]). Review vaccination status for all patients, and if possible, bring up to date with all immunizations (following current immunization guideline recommendations) prior to rituximab initiation and administer nonlive vaccines at least 4 weeks prior to initiating a rituximab course of therapy. Response to some immunizations may be lower in some patients receiving rituximab.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous [preservative free]:

Riabni: rituximab-arrx 100 mg/10 mL (10 mL); rituximab-arrx 500 mg/50 mL (50 mL) [contains polysorbate 80]

Rituxan: 100 mg/10 mL (10 mL [DSC]); 10 mg/mL (10 mL, 50 mL) [contains polysorbate 80]

Ruxience: rituximab-pvvr 100 mg/10 mL (10 mL); rituximab-pvvr 500 mg/50 mL (50 mL) [contains edetate (edta) disodium dihydrate, polysorbate 80]

Truxima: rituximab-abbs 100 mg/10 mL (10 mL); rituximab-abbs 500 mg/50 mL (50 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (Riabni Intravenous)

100 mg/10 mL (per mL): $86.02

500 mg/50 mL (per mL): $86.02

Solution (Rituxan Intravenous)

100 mg/10 mL (per mL): $112.74

500 mg/50 mL (per mL): $112.74

Solution (Ruxience Intravenous)

100 mg/10 mL (per mL): $86.02

500 mg/50 mL (per mL): $86.02

Solution (Truxima Intravenous)

100 mg/10 mL (per mL): $101.47

500 mg/50 mL (per mL): $101.47

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Concentrate, Intravenous:

Riabni: 10 mg/mL (10 mL, 50 mL) [contains polysorbate 80]

Rituxan: 10 mg/mL (10 mL, 50 mL) [contains polysorbate 80]

Riximyo: 10 mg/mL (10 mL, 50 mL) [contains polysorbate 80]

Ruxience: 10 mg/mL (10 mL, 50 mL) [contains edetate (edta) disodium dihydrate, polysorbate 80]

Solution, Intravenous:

Truxima: 100 mg/10 mL (10 mL); 500 mg/50 mL (50 mL) [contains polysorbate 80]

Administration: Pediatric

IV infusion: Must be diluted prior to administration; do not administer undiluted or as an IV push or rapid injection. Premedicate with acetaminophen, an antihistamine, with/without corticosteroid as indicated. For oncology uses in pediatric patients, in addition to prednisone which is part of the chemotherapeutic regimen, premedicate 30 to 60 minutes prior to the rituximab infusion with acetaminophen and an H1 antihistamine (eg, diphenhydramine). For granulomatosis with polyangiitis, microscopic polyangiitis, and Wegener granulomatosis, in addition to an antihistamine and acetaminophen, patients should also be premedicated 30 minutes prior to each infusion with methylprednisolone (eg, 100 mg IV in adults or equivalent).

In pediatric trials, described infusion rates vary and are indication specific. One retrospective report (Ref) evaluated rituximab infusion in 67 pediatric patients for multiple uses (mostly autoimmune disease [58%] and oncology uses [36%]) and used a 2 mg/mL concentration. In the trial, patients were premedicated with intravenous diphenhydramine (1 mg/kg up to 50 mg/dose) and oral acetaminophen (10 mg/kg up to 650 mg/dose); corticosteroid premedication was at prescriber discretion. Overall, infusions were well tolerated; 5 (2.7% incidence) infusion related reactions were reported and were grade 1 or 2 severity). Infusions were administered with the following:

First dose: Initial rate: 0.5 mg/kg/hour (maximum rate: 50 mg/hour) for 1 hour; if tolerated, then rate increase in 0.5 mg/kg/hour increments every 30 minutes up to a maximum 400 mg/hour (Ref). If hypersensitivity or infusion-related reactions occur, slow or interrupt the infusion. If symptoms completely resolve, resume infusion at 50% of the previous rate.

Subsequent doses (if first dose well tolerated): Initial rate: 1 mg/kg/hour (maximum rate: 50 mg/hour [per the manufacturer]; 100 mg/hour has been reported (Ref)) for 1 hour; if tolerated, then increase rate in 1 mg/kg/hour increments every 30 minutes up to a maximum 400 mg/hour (Ref). If hypersensitivity or infusion-related reactions occur, slow or interrupt the infusion. If symptoms completely resolve, resume infusion at 50% of the previous rate.

Refer to specific protocols for administration rate guidelines.

Indication-specific information: Limited data available: Infusion data reported from experience in pediatric trials. If hypersensitivity or infusion-related reactions occur, slow or interrupt the infusion. If symptoms completely resolve, resume infusion at 50% of the previous rate (manufacturer's labeling).

Acute leukemia: 0.5 mg/kg/hour for the first hour; if tolerated, rate was increased every 30 minutes to maximum rate of 400 mg/hour in trials (Ref); in some oncology trials, doses were infused over 6 to 8 hours (Ref).

Autoimmune hemolytic anemia: Doses were infused over 5 hours (Ref).

Granulomatosis with polyangiitis and microscopic polyangiitis: Note: Although an FDA-approved indication, administration to pediatric patients is not described in the manufacturer's labeling.

Initial infusions: In the clinical trial (n=25, age range: 6 to 17 years), infusions were initiated at a rate of 25 mg/hour. If no hypersensitivity or infusion-related reactions occurred, infusion rates were increased in 25 mg/hour increments every 30 minutes to a maximum infusion rate of 200 mg/hour as tolerated (Ref). Note: In the clinical trial utilizing these rates of administration, the youngest patient enrolled was 6 years of age.

Nephrotic syndrome: Doses were infused over 3 to 4 hours (Ref).

Non-Hodgkin lymphoma: 0.5 mg/kg/hour for the first hour; if tolerated, rate was increased every 30 minutes to maximum rate of 400 mg/hour in trials (Ref).

Posttransplant lymphoproliferative disorder: Doses were infused over 2 to 8 hours (Ref).

Systemic lupus erythematosus: Doses of 187.5 mg/m2 were infused over 4 hours (Ref); doses of 375 mg/m2 were infused over 6 to 8 hours (Ref); the infusion time of the higher 750 mg/m2 doses was not reported.

Rapid rate infusions: Children and Adolescents: Multiple regimens have been reported and most experience reported with nononcologic uses of rituximab (Ref). Note: Rapid infusion rates should not be used for initial infusions, in unstable patients, patients at risk for tumor lysis syndrome or with an absolute lymphocyte count >5,000/mm3 (Ref).

90-minute infusion: IV: Infuse 20% of the dose over the first 30 minutes; if tolerated, increase rate to deliver the remaining 80% of the dose over 60 minutes (Ref). Infusion protocol reported in 17 pediatric and young adult patients (age range: 2 to 23 years of age) for 37 infusions (majority of doses were 375 mg/m2); patients were premedicated with diphenhydramine and acetaminophen (doses not reported); concentration of infusion not reported. The results showed one grade 1 infusion related reaction (hypotension) in a single patient who also took amlodipine on the morning prior to infusion (which was not recommended) (Ref).

60-minute infusion: Reported only in nononcologic uses and for doses of 375 mg/m2: IV: Infuse dose over 60 minutes (Ref). Infusion protocol reported in 20 pediatric patients (mean age: 10.2 years; range: 4 months to 14 years) for 64 pediatric infusions with mostly autoimmune cytopenias, Epstein-Barr viremia, and graft-vs-host disease; patients were premedicated with diphenhydramine and acetaminophen (doses not reported); corticosteroids were administered according to clinician discretion and protocols (4 of the 20 patients did not receive corticosteroids nor have infusion-related reactions); 2 adverse events were observed; 1 resolved and the other lead to therapy discontinuation; concentration of infusion not reported (Ref).

Administration: Adult

Note: Refer to specific protocol for administration rate guidelines.

IV: For IV administration only. Do not administer IV push or bolus. Do not administer IV rituximab subcutaneously. If an infusion-related reaction occurs, slow or stop the infusion. If the reaction abates, restart infusion at 50% of the previous rate. Discontinue infusion in the event of serious or life-threatening cardiac arrhythmias.

Initial infusion: Start infusion at a rate of 50 mg/hour; if there is no infusion-related reaction, increase the rate by 50 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour.

Subsequent infusions:

Standard infusion rate: If patient tolerated initial infusion, start at 100 mg/hour; if there is no infusion-related reaction, increase the rate by 100 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour.

Accelerated infusion rate (90 minutes): For adult patients with previously untreated follicular NHL and diffuse large B-cell NHL who are receiving a corticosteroid as part of their combination chemotherapy regimen, have a circulating lymphocyte count <5,000/mm3, or have no significant cardiovascular disease. After tolerance has been established (no grade 3 or 4 infusion-related event) at the recommended infusion rate in cycle 1, a rapid infusion rate may be used beginning with cycle 2. The daily corticosteroid, acetaminophen, and diphenhydramine are administered prior to treatment, then the rituximab dose is administered over 90 minutes, with 20% of the dose administered over the first 30 minutes and the remaining 80% is given over 60 minutes (Ref). If the 90-minute infusion in cycle 2 is tolerated, the same rate may be used for the remainder of the treatment regimen (through cycles 6 or 8).

Storage/Stability

Storage time varies by product; refer to individual product labeling for details.

Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Do not shake. Protect vials from direct sunlight.

Rituxan, Truxima: Solutions diluted for infusion in NS or D5W may be stored at 2°C to 8°C (36°F to 46°F) for 24 hours and are stable at room temperature for an additional 24 hours (Rituxan or Truxima), although because there is no preservative, the manufacturers recommend storing refrigerated.

Riabni: If not used immediately, solutions diluted for infusion in NS may be stored at 2°C to 8°C (36°F to 46°F) for 7 days and solutions diluted for infusion in D5W may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours.

Ruxience: If not used immediately, solutions diluted for infusion in NS may be stored at 2°C to 8°C (36°F to 46°F) for up to 16 days and solutions diluted for infusion in D5W may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Riabni: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761140s001lbl.pdf#page=41

Rituxan: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf#page=56

Ruxience: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761103s011lbl.pdf#page=42

Truxima: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf#page=49

Use

Nononcologic uses: Treatment of granulomatosis with polyangiitis (Wegener granulomatosis) and microscopic polyangiitis in combination with glucocorticoids (Rituxan: FDA approved in ages ≥2 years and adults; Ruxience: FDA approved in adults); treatment of moderately- to severely-active rheumatoid arthritis (in combination with methotrexate) in patients with inadequate response to one or more tumor necrosis factor antagonists (Rituxan: FDA approved in adults); treatment of moderate to severe pemphigus vulgaris (Rituxan: FDA approved in adults).

Oncologic uses: Treatment of previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL) in combination with chemotherapy (FDA approved in pediatric patients ≥6 months of age). Treatment of CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) (including relapsed or refractory, low-grade or follicular B-cell NHL [as a single agent]; follicular B-cell NHL, previously untreated [in combination with first-line chemotherapy, and as single-agent maintenance therapy if response to first-line rituximab with chemotherapy]; nonprogressing, low-grade B-cell NHL [as a single agent after first-line CVP treatment]; diffuse large B-cell NHL, previously untreated [in combination with CHOP chemotherapy or other anthracycline-based regimen]) and treatment of CD20-positive chronic lymphocytic leukemia (in combination with cyclophosphamide and fludarabine) (Rituxan, Ruxience, Truxima: FDA approved in adults).

Has also been used for the treatment of systemic autoimmune disorders (eg, autoimmune hemolytic anemia); refractory systemic lupus erythematosus; steroid-refractory chronic graft-versus-host disease; refractory nephrotic syndrome; chronic immune thrombocytopenia; posttransplant lymphoproliferative disorder.

Note: Ruxience (rituximab-pvvr) and Truxima (rituximab-abbs), are approved as biosimilar agents; market availability unknown (see Product Availability). Approved ages and uses may vary (consult product labeling).

Medication Safety Issues
Sound-alike/look-alike issues:

Rituxan may be confused with Remicade, Rituxan Hycela

RiTUXimab may be confused with bevacizumab, brentuximab vedotin, dinutuximab, inFLIXimab, obinutuzumab, ofatumumab, polatuzumab vedotin, ramucirumab, rituximab and hyaluronidase, ruxolitinib, siltuximab, ustekinumab

High alert medication:

This medication is in a class the Institute for Safe Medication Practices includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

Administration issues:

Rituximab is for intravenous (IV) administration only. Do not substitute rituximab and hyaluronidase (SubQ) for rituximab (IV). Use caution during product selection, preparation, and administration.

The rituximab dose for rheumatoid arthritis is a flat dose (1,000 mg) and is not based on body surface area (BSA). Follow-up dosing for granulomatosis with polyangiitis and microscopic polyangiitis are flat doses and not based on BSA.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Antithymocyte Globulin (Equine): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of anti-CD20 B-cell depleting therapy is reduced. Anti-CD20 B-Cell Depleting Therapies may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid combination

Belimumab: May enhance the immunosuppressive effect of RiTUXimab. Risk X: Avoid combination

Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chikungunya Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider therapy modification

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Poliovirus Vaccine (Live/Trivalent/Oral): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification

Vaccines (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Yellow Fever Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Verify pregnancy status prior to treatment initiation in patients who may become pregnant.

The manufacturer recommends patients who may become pregnant use effective contraception during therapy and for 12 months following the last rituximab dose.

Based on limited data, use of rituximab may be continued through conception in patients with rheumatic and musculoskeletal diseases who are planning a pregnancy and not able to use alternative therapies; use should be discontinued once pregnancy is confirmed. Conception should be planned during a period of quiescent/low disease activity (ACR [Sammaritano 2020]).

Rituximab has been evaluated off-label for neuromyelitis optica spectrum disorder (NMOSD). Use of rituximab prior to pregnancy may prevent pregnancy-related attacks (Borisow 2018; Kim 2020).

Based on limited data, use of rituximab may be continued in patients with rheumatic and musculoskeletal diseases who are planning to father a child (ACR [Sammaritano 2020]).

Pregnancy Considerations

Rituximab crosses the placenta and can be detected in the newborn.

Rituximab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009). In one infant born at 41 weeks' gestation, in utero exposure occurred from week 16 to 37; rituximab concentrations were higher in the neonate at birth (32,095 ng/mL) than the mother (9,750 ng/mL) and still measurable at 18 weeks of age (700 ng/mL infant; 500 ng/mL mother) (Friedrichs 2006).

Outcome data following maternal use of rituximab during pregnancy are available (Chakravarty 2011; Das 2018; De Cock 2017; Dernoncourt 2023; Ghalandari 2022; Perrotta 2021). Although reassuring, available safety data are limited (ACOG 2019). B-cell lymphocytopenia generally lasting <6 months may occur following in utero exposure. Infants and newborns exposed to rituximab during pregnancy should be monitored for infection.

The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team) approach. Based on limited data, if pregnancy occurs during rituximab treatment, rituximab should ideally be withheld. However, if postponing rituximab would significantly compromise maternal outcomes in patients diagnosed with B-cell lymphoma during pregnancy, rituximab use is not discouraged (ESMO [Peccatori 2013]). An international consensus panel has published guidelines for hematologic malignancies during pregnancy. In patients with aggressive lymphomas, rituximab (as a component of the R-CHOP chemotherapy regimen) may be administered in the second and third trimesters, however, it should be avoided within 3 weeks of anticipated delivery (Lishner 2016).

Although approved for the treatment of rheumatoid arthritis, based on available data, rituximab should be discontinued once pregnancy is detected in patients treated for rheumatic and musculoskeletal diseases; treatment during pregnancy should only be considered for pregnant patients with life- or organ-threatening disease (ACR [Sammaritano 2020]).

Rituximab is used off-label for the treatment of primary immune thrombocytopenia (ITP). Although data specific to pregnancy are limited, use can be considered in pregnant patients with very severe ITP. Monitor for perinatal and neonatal immunosuppression and subsequent infection (Donohoe 2019; Provan 2019).

Rituximab has been evaluated off-label for neurological indications such as multiple sclerosis (Ciplea 2020; Das 2018; Smith 2020) and neuromyelitis optica spectrum disorder (NMOSD). Maternal NMOSD may be associated with adverse pregnancy outcomes, including miscarriage and preeclampsia. Data related to the treatment of NMOSD during pregnancy are limited; however, use of rituximab prior to pregnancy may prevent pregnancy-related attacks (Borisow 2018; Chang 2020; Kim 2020; Miranda-Acuña 2019; Munger 2020; Seyed Ahadi 2021; Zhu 2020).

A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (1-877-635-4499).

Monitoring Parameters

CBC with differential and platelets (pediatric and adult pediatric with lymphoid malignancies: baseline, prior to each treatment course, at weekly to monthly intervals and more frequently if cytopenias develop; pediatric and adult patients with granulomatosis with polyangiitis and microscopic polyangiitis: at 2- to 4-month intervals; in adult patients with rheumatoid arthritis: at 2- to 4-month intervals); continue to monitor for cytopenias after the final dose and until resolution, electrolytes (in patients at risk for tumor lysis syndrome [TLS]), renal function (in patients at risk for TLS), fluid/hydration status balance; blood pressure, vital signs.

Monitor for infusion reactions; signs of active hepatitis B infection (during and for up to 12 months after therapy completion); cardiac monitoring during and after infusion (in rheumatoid arthritis patients and in patients with preexisting cardiac disease or if arrhythmias develop during or after subsequent infusions); monitor for signs/symptoms of bowel obstruction/perforation (abdominal pain, vomiting); signs or symptoms of progressive multifocal leukoencephalopathy (PML) (focal neurologic deficits, which may present as hemiparesis, visual field deficits, cognitive impairment, aphasia, ataxia, and/or cranial nerve deficits); if PML is suspected, obtain brain MRI scan and lumbar puncture; signs/symptoms of TLS and/or mucocutaneous skin reactions.

Screen all patients for hepatitis B virus (HBV) infection prior to therapy initiation (eg, hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [anti-HBc] measurements). In addition, carriers and patients with evidence of current infection or recovery from prior hepatitis B infection should be monitored closely for clinical and laboratory signs of HBV reactivation and/or infection during therapy and for up to 2 years following completion of treatment. HBV screening recommendations from adult experience (Hwang 2015): Screen for HBV infection with HBsAg and anti-HBc tests prior to treatment initiation; either a total anti-HBc (with both IgG and IgM) or anti-HBc IgG test should be used to screen for chronic or resolved HBV infection (do not use anti-HBc IgM as it may only confirm acute HBV infection). HBsAg negative/anti-HBc positive patients should be monitored for HBV reactivation with HBV DNA and ALT testing approximately every 3 months during treatment.

Mechanism of Action

Rituximab is a monoclonal antibody directed against the CD20 antigen on the surface of B-lymphocytes. CD20 regulates cell cycle initiation; and, possibly, functions as a calcium channel. Rituximab binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity. B-cells are believed to play a role in the development and progression of rheumatoid arthritis. Signs and symptoms of rheumatoid arthritis are reduced by targeting B-cells and the progression of structural damage is delayed.

Pharmacokinetics (Adult Data Unless Noted)

Onset:

Immune thrombocytopenia: Initial response: 7 to 56 days; Peak response: 14 to 180 days (ASH [Neunert 2011]).

Non-Hodgkin lymphomas: B-cell depletion: Within 3 weeks.

Rheumatoid arthritis: B-cell depletion: Within 2 weeks.

Duration:

Non-Hodgkin lymphomas: Detectable in serum 3 to 6 months after completion of treatment; B-cell depletion is sustained for up to 6 to 9 months and B-cell recovery begins ~6 months following completion of treatment; median B-cell levels return to normal by 12 months following completion of treatment.

Rheumatoid arthritis: B-cell depletion persists for at least 6 months.

Distribution:

Pemphigus vulgaris: Median: 3.49 L (range: 2.48 to 5.22 L).

Rheumatoid arthritis: 3.1 L.

Granulomatosis with polyangiitis/microscopic polyangiitis:

Children ≥6 years of age and Adolescents ≤17 years of age: Median: 2.28 L (range: 1.43 to 3.17 L).

Adults: Median: 3.12 L (range: 2.42 to 3.91 L).

Half-life elimination:

Chronic lymphocytic leukemia: Median terminal half-life: 32 days (range: 14 to 62 days).

Non-Hodgkin lymphomas: Median terminal half-life: 22 days (range: 6 to 52 days).

Pemphigus vulgaris: Median terminal half-life: First cycle (1,000 mg on days 1, 15): 21.1 days (range: 9.3 to 36.2 days); second cycle (1,000 mg on days 168, 182): 26.2 days (range: 16.4 to 42.8 days).

Rheumatoid arthritis: Mean terminal half-life: 18 days (range: 5 to 78 days).

Granulomatosis with polyangiitis/microscopic polyangiitis:

Children ≥6 years of age and Adolescents ≤17 years of age: Median terminal half-life: 22 days (range: 11 to 42 days).

Adults: Median terminal half-life: 25 days (range: 11 to 52 days).

Excretion: Clearance:

Pemphigus vulgaris: Median: First cycle (1,000 mg on days 1, 15): 0.3 L/day (range: 0.16 to 1.51 L/day); second cycle (1,000 mg on days 168, 182): 0.24 L/day (range: 0.13 to 0.45 L/day).

Rheumatoid arthritis: 0.335 L/day.

Granulomatosis with polyangiitis/microscopic polyangiitis:

Children ≥6 years and Adolescents ≤17 years of age: Median: 0.222 L/day (range: 0.0996 to 0.381 L/day).

Adults: Median: 0.279 L/day (range: 0.133 to 0.653 L/day).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Mabthera | Rixathon | Ruxience | Truxima;
  • (AR) Argentina: Mabthera | Novex | Rixathon | Ruxience | Truxima;
  • (AT) Austria: Mabthera | Ritemvia | Rixathon | Riximyo | Ruxience | Truxima;
  • (AU) Australia: Mabthera | Riximyo | Truxima;
  • (BE) Belgium: Mabthera | Rixathon | Ruxience | Truxima;
  • (BG) Bulgaria: Rixathon | Truxima;
  • (BR) Brazil: Riximyo | Ruxience | Truxima | Vivaxxia;
  • (CH) Switzerland: Mabthera | Rixathon | Truxima;
  • (CI) Côte d'Ivoire: Mabthera;
  • (CL) Chile: Mabthera | Reditux;
  • (CN) China: Han li kang | Mabthera;
  • (CO) Colombia: Acellbia | Iximab | Maball | Mabthera | Ritoxen | Rituxan | Rixathon | Ruxience | Rytuzeq | Truxima;
  • (CZ) Czech Republic: Mabthera | Rixathon | Ruxience | Truxima;
  • (DE) Germany: Blitzima | Mabthera | Rixathon | Ruxience | Truxima;
  • (DO) Dominican Republic: Mabthera | Usmal;
  • (EC) Ecuador: Mabthera | Reditux | Truxima;
  • (EE) Estonia: Mabthera | Rixathon | Ruxience;
  • (EG) Egypt: Mabthera | Rixathon;
  • (ES) Spain: Mabthera | Rixathon | Ruxience | Truxima;
  • (ET) Ethiopia: Maball | Mabthera;
  • (FI) Finland: Mabthera | Ritemvia | Rixathon | Ruxience | Truxima;
  • (FR) France: Rixathon | Ruxience | Truxima;
  • (GB) United Kingdom: Mabthera | Rixathon | Ruxience | Truxima;
  • (GR) Greece: Mabthera | Rixathon;
  • (HK) Hong Kong: Mabthera | Truxima;
  • (HR) Croatia: Rixathon;
  • (HU) Hungary: Blitzima | Mabthera | Ritemvia | Rituzena | Rixathon | Ruxience | Truxima;
  • (ID) Indonesia: Mabthera | Rituxikal | Rituxsanbe;
  • (IE) Ireland: Mabthera | Rixathon | Riximyo | Ruxience | Truxima;
  • (IL) Israel: Mabthera;
  • (IN) India: Emtux | Enfiera | Maball | Mabtas | Mabtas t | Rituxipca | Rituxirel | X mab | Zestmab;
  • (IT) Italy: Mabthera | Rixathon | Ruxience | Truxima;
  • (JO) Jordan: Mabthera | Tromax;
  • (JP) Japan: Rituxan;
  • (KE) Kenya: Intamab | Mabthera | Rilast | Rituxirel;
  • (KR) Korea, Republic of: Mabthera | Truxima;
  • (LB) Lebanon: Mabthera | Rixathon;
  • (LT) Lithuania: Mabthera | Rixathon | Ruxience;
  • (LV) Latvia: Mabthera | Rixathon | Truxima;
  • (MA) Morocco: Mabthera | Zelva;
  • (MX) Mexico: Arasamila | Blitzima | Kikuzubam | Mabthera | Rigetuxer | Ruxience;
  • (MY) Malaysia: Mabthera | Truxima;
  • (NL) Netherlands: Mabthera | Rixathon | Ruxience | Truxima;
  • (NO) Norway: Mabthera | Rixathon;
  • (NZ) New Zealand: Mabthera | Riximyo | Truxima;
  • (PE) Peru: Mabthera | Reditux | Rilast | Rixathon | Truxima | Zaytux;
  • (PH) Philippines: Mabthera;
  • (PK) Pakistan: Mabthera | Tuximab;
  • (PL) Poland: Blitzima | Mabthera | Riximyo;
  • (PR) Puerto Rico: Rituxan;
  • (PT) Portugal: Blitzima | Mabthera | Rixathon | Riximyo | Ruxience | Truxima;
  • (PY) Paraguay: Mabthera | Rituximab bioeticos | Tidecron;
  • (QA) Qatar: Mabthera | Rixathon | Truxima;
  • (RO) Romania: Rixathon;
  • (RU) Russian Federation: Acelbia | Acellbia | Mabthera | Reddytux;
  • (SA) Saudi Arabia: Mabthera | Truxima;
  • (SE) Sweden: Mabthera | Ritemvia | Rixathon | Ruxience | Truxima;
  • (SG) Singapore: Mabthera | Rixathon | Truxima;
  • (SI) Slovenia: Blitzima | Mabthera | Rixathon;
  • (SK) Slovakia: Blitzima | Mabthera | Rixathon | Riximyo | Ruxience;
  • (TH) Thailand: Mabthera | Redditux | Rixathon | Truxima;
  • (TN) Tunisia: Mabthera | Redditux;
  • (TR) Turkey: Mabthera | Redditux | Truxima;
  • (TW) Taiwan: Mabthera | Rixathon;
  • (UA) Ukraine: Mabthera | Reditux | Rituxim | Rixathon | Ruxience | Truxima;
  • (UG) Uganda: Mabthera;
  • (UY) Uruguay: Mabthera | Novex | Rixathon;
  • (ZA) South Africa: Blitzima | Mabthera | Redditux | Rixathon;
  • (ZW) Zimbabwe: Mabthera
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