rituximab (Rx)

Brand and Other Names:Rituxan, Truxima, more...rituximab-abbs, Ruxience, rituximab-pvvr, rituximab-arrx, Riabni
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution (single-dose vials)

  • 10mg/mL (10mL, 50mL vials)

Non-Hodgkin Lymphoma

Rituxan, Ruxience, Riabni, Truxima

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL

  • Indicated for treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
  • 375 mg/m2 IV once weekly x 4-8 doses  
  • Retreatment: 375 mg/m2 IV once weekly x 4 doses
  • In combination with ibritumomab
    • Day 1: Rituximab 250 mg/m2 IV
    • Day 7, 8, or 9: Rituximab 250 mg/m2 IV; administer ibritumomab within 4 hr following completion of rituximab infusion
    • Refer to ibritumomab tiuxetan for full prescribing information regarding regimen

Previously untreated follicular, CD20-positive, B-cell NHL

  • Indicated in previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab product in combination with chemotherapy, as single-agent maintenance therapy
  • 375 mg/m2 IV on Day 1 of each chemotherapy cycle for up to 8 doses
  • Maintenance therapy following 8 weeks after completion of combination chemotherapy in patients with complete or partial response: Initiate as a single-agent q8weeks x 12 doses
  • In combination with ibritumomab
    • Day 1: Rituximab 250 mg/m2 IV
    • Day 7, 8, or 9: Rituximab 250 mg/m2 IV; administer ibritumomab within 4 hr following completion of rituximab infusion
    • Refer to ibritumomab tiuxetan for full prescribing information regarding regimen

Nonprogressing (including stable disease), low-grade, CD20-positive, B-cell NHL

  • Indicated for treatment in patients with nonprogressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
  • Following completion of 6-8 cycles of CVP chemotherapy, 375 mg/m2 IV once weekly x 4 doses at 6-month intervals for up to 16 doses

Previously untreated diffuse large B-cell, CD20-positive NHL

  • Indicated for treatment in patients with previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
  • 375 mg/m2 IV on Day 1 of each cycle of chemotherapy for up to 8 infusions

Chronic Lymphocytic Leukemia

Rituxan, Ruxience, Riabni, Truxima

Indicated for untreated and previously treated CD20-positive CLL; combined therapy with fludarabine and cyclophosphamide (FC)

375 mg/m2 IV infusion on Day 1 of 1st cycle (for 1st cycle, administer 1 day before chemotherapy with FC), THEN  

500 mg/m2 IV on Day 1 of cycles 2-6 (administer on same day as chemotherapy with FC)

Fludarabine & cyclophosphamide dosage

  • Fludarabine: 25 mg/m2 IV qDay x 3 days
  • Cyclophosphamide: 250 mg/m2 IV qDay x 3 days
  • Repeat q28 days x 6 cycles

Rheumatoid Arthritis

Rituxan or Truxima

1000 mg IV infusion, repeat after 2 week (2 infusions separated by 2 week is 1 course)

Repeat course q24weeks or based on clinical evaluation (but no sooner than 16 weeks)

Use in combination with methotrexate

Premedicate with glucocorticoids 30 minutes before infusion to reduce infusion rxn

Not to exceed 1000 mg/dose

Wegener Granulomatosis

Rituxan, Ruxience, Riabni, Truxima

Indicated for adults with granulomatosis with polyangiitis (GPA; Wegener granulomatosis) in combination with glucocorticoids

Induction: 375 mg/m2 IV qWeek x 4 weeks  

Follow up treatment

  • If disease control achieved with induction treatment, initiate follow up treatment
  • Induction treatment with rituximab: Initiate follow up treatment within 24 weeks after last rituximab induction dose or based on clinical evaluation, but no sooner than 16 weeks after last induction dose
  • Induction treatment with other standard of care immunosuppressants: Initiate follow up treatment within 4 weeks following achievement of disease control
  • 500 mg IV on Days 1 and 15, THEN q6months thereafter based on clinical evaluation

Glucocorticoid regimen

  • Also see premedication
  • Induction
    • Methylprednisolone 1000 mg IV qDay x 1-3 days followed by prednisone PO 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms
    • Begin within 14 days before or with initiation of rituximab and may continue during and after the 4 week induction course
  • Follow up treatment
    • Methylprednisolone 100 mg IV to be completed 30 minutes before each rituximab IV infusion

Microscopic Polyangiitis

Rituxan, Ruxience, Riabni, Truxima

Indicated for adults with microscopic polyangiitis (MPA) in combination with glucocorticoids

Induction: 375 mg/m2 IV qWeek x 4 weeks  

Follow up treatment

  • If disease control achieved with induction treatment, initiate follow up treatment
  • Induction treatment with rituximab: Initiate follow up treatment within 24 weeks after last rituximab induction dose or based on clinical evaluation, but no sooner than 16 weeks after last induction dose
  • Induction treatment with other standard of care immunosuppressants: Initiate follow up treatment within 4 weeks following achievement of disease control
  • 500 mg IV on Days 1 and 15, THEN q6months thereafter based on clinical evaluation

Glucocorticoid regimen

  • Also see premedication
  • Induction
    • Methylprednisolone 1000 mg IV qDay x 1 to 3 days followed by prednisone PO 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms
    • Begin within 14 days before or with initiation of rituximab and may continue during and after the 4 week induction course
  • Follow up treatment
    • Methylprednisolone 100 mg IV to be completed 30 minutes before each rituximab IV infusion

Pemphigus Vulgaris

Rituxan only

Indicated for adults with moderate-to-severe pemphigus vulgaris (PV)

Initial: 1000 mg IV once, then repeat dose in 2 weeks (ie, two 1000-mg doses 2 weeks apart); use in combination with a tapering course of glucocorticoids

Maintenance: 500 mg IV at Month 12 and q6Months thereafter or based on clinical evaluation

Treatment relapse: 1000 mg IV and consider resuming or increasing the glucocorticoid dose based on clinical evaluation

Orphan Designations

Treatment of immune thrombocytopenic purpura (ITP)

Sponsor

  • Genentech, Inc; 1 DNA Way; South San Francisco, CA 94080-4990

Rasmussen Encephalitis (Orphan)

Orphan designation for treatment of Rasmussen encephalitis

Sponsor

  • Keck Graduate Institute of Applied Life Sciences; 535 Watson Drive; Claremont, California 91711

Dosage Forms & Strengths

injectable solution (single-dose vials)

  • 10mg/mL (10mL, 50mL vials)

Granulomatosis with Polyangiitis and Microscopic Polyangiitis

Indicated in combination with glucocorticoids for children aged ≥2 years with granulomatosis with polyangiitis (GPA) (Wegener granulomatosis) and for microscopic polyangiitis (MPA)

Induction: 375 mg/m2 IV qWeek for 4 weeks

Before first infusion, administer methylprednisolone 30 mg/kg IV (not to exceed 1g/day) qDay for 3 days

Following methylprednisolone IV, continue oral corticosteroids per clinical practice

Follow up treatment of patients who achieve disease control with induction treatment

  • 250 mg/m2 IV x2 doses separated by 2 weeks, THEN
  • 250 mg/m2 IV q6months thereafter based on clinical evaluation
  • If induction treatment of active disease was with a rituximab product, initiate follow up treatment with rituximab within 24 weeks, but no sooner than 16 weeks after last induction infusion based on clinical evaluation
  • If induction treatment of active disease was with other standard of care immunosuppressants, initiate rituximab follow up treatment within the 4 week period following achievement of disease control

Rheumatoid Arthritis

Not studied in pediatric patients with polyarticular juvenile idiopathic arthritis (PJIA) due to concerns regarding the potential for prolonged immunosuppression as a result of B-cell depletion in the developing juvenile immune system

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Interactions

Interaction Checker

and rituximab

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    Contraindicated

      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (14)

              • adenovirus types 4 and 7 live, oral

                rituximab, adenovirus types 4 and 7 live, oral. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • baricitinib

                baricitinib, rituximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

              • certolizumab pegol

                rituximab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

              • influenza virus vaccine quadrivalent, intranasal

                rituximab, influenza virus vaccine quadrivalent, intranasal. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • measles (rubeola) vaccine

                rituximab, measles (rubeola) vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • measles mumps and rubella vaccine, live

                rituximab, measles mumps and rubella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • measles, mumps, rubella and varicella vaccine, live

                rituximab, measles, mumps, rubella and varicella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • palifermin

                palifermin increases toxicity of rituximab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • rotavirus oral vaccine, live

                rituximab, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • rubella vaccine

                rituximab, rubella vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • smallpox (vaccinia) vaccine, live

                rituximab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • varicella virus vaccine live

                rituximab, varicella virus vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • yellow fever vaccine

                rituximab, yellow fever vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              • zoster vaccine live

                rituximab, zoster vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

              Monitor Closely (33)

              • amphotericin B deoxycholate

                amphotericin B deoxycholate and rituximab both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Caution should be exercised when concurrent therapy is used. Patients should be monitored for signs of renal failure.

              • belatacept

                belatacept and rituximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cholera vaccine

                rituximab, cholera vaccine. immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • cisplatin

                cisplatin and rituximab both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Potential for renal toxicity when used in combination with cisplatin.

              • dengue vaccine

                rituximab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                rituximab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fingolimod

                rituximab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • hepatitis A vaccine inactivated

                rituximab, hepatitis A vaccine inactivated. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • hepatitis a/b vaccine

                rituximab, hepatitis a/b vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • hepatitis b vaccine

                rituximab, hepatitis b vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • HIV vaccine

                rituximab, HIV vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • human papillomavirus vaccine, nonavalent

                rituximab, human papillomavirus vaccine, nonavalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • human papillomavirus vaccine, quadrivalent

                rituximab, human papillomavirus vaccine, quadrivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza A (H5N1) vaccine

                rituximab, influenza A (H5N1) vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine (H5N1), adjuvanted

                rituximab, influenza virus vaccine (H5N1), adjuvanted. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine quadrivalent

                rituximab, influenza virus vaccine quadrivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine quadrivalent, adjuvanted

                rituximab, influenza virus vaccine quadrivalent, adjuvanted. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine quadrivalent, cell-cultured

                rituximab, influenza virus vaccine quadrivalent, cell-cultured. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine trivalent

                rituximab, influenza virus vaccine trivalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • influenza virus vaccine trivalent, adjuvanted

                rituximab, influenza virus vaccine trivalent, adjuvanted. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • ioversol

                ioversol and rituximab both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.

              • Japanese encephalitis virus vaccine

                rituximab, Japanese encephalitis virus vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • mechlorethamine

                mechlorethamine, rituximab. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with mechlorethamine may increase the risk of immunosuppression and myelosuppression.

              • ofatumumab SC

                ofatumumab SC, rituximab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • poliovirus vaccine inactivated

                rituximab decreases effects of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response may be suboptimal. Patients on chemotherapy with anti-B cell antibodies should wait =6 months after therapy before being vaccinated with inactivated vaccines.

              • ponesimod

                ponesimod and rituximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • rabies vaccine

                rituximab, rabies vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • rabies vaccine chick embryo cell derived

                rituximab, rabies vaccine chick embryo cell derived. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • siponimod

                siponimod and rituximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                rituximab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab

                trastuzumab, rituximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, rituximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • zoster vaccine recombinant

                rituximab, zoster vaccine recombinant. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              Minor (0)

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                Adverse Effects

                >10%

                NHL

                • Angioedema (11%)
                • Asthenia (26%), chills (33%), dizziness (10%), fever (53%), headache (19%)
                • Pruritus (14%), rash (15%)
                • Abdominal pain (14%), diarrhea (10%), nausea (23%), vomiting (10%)
                • Leukopenia (14%), lymphopenia (48%), neutropenia (14%), thrombocytopenia (12%)
                • Back pain (10%), myalgia (10%)
                • Cough (13%), rhinitis (12%)
                • Infection (31%), night sweats (15%)

                GPA and MPA

                • Nausea (18%)
                • Diarrhea (17%)
                • Headache (17%)
                • Muscle spasms (17%)
                • Anemia (16%)
                • Peripheral edema (16%)
                • Insomnia (14%)
                • Arthralgia (13%)
                • Cough (13%)
                • Fatigue (13%)
                • Increased ALT (13%)
                • Hypertension (12%)
                • Epistaxis (11%)

                PV

                • Infusion reactions (58%)
                • Depression (18%)
                • Herpes simplex (13%)
                • Alopecia (13%)

                1-10%

                NHL

                • Edema
                • Flushing
                • Hypertension
                • Anxiety
                • Anemia
                • Elevated LDH
                • Hyperglycemia
                • Bronchospasm, dyspnea, sinusitis, throat irritation, urticaria

                RA (Rituximab+Methotrexate vs Methotrexate Alone)

                • Hypertension
                • Anxiety, asthenia, chills, migraine, paresthesia, pyrexia
                • Pruritus, urticaria
                • Dyspepsia, nausea, upper abd pain
                • Hypercholesterolemia
                • Arthralgia
                • Rhinitis, throat irritation, URI

                GPA and MPA

                • Dyspnea (10%)
                • Leukopenia (10%)
                • Rash (10%)

                PV

                • Fatigue (8%)
                • Upper abdominal pain (5%)
                • Conjunctivitis (5%)
                • Dizziness, headache (5%)
                • Herpes zoster (5%)
                • Irritability (5%)
                • Muscular pain (5%)
                • Pyrexia (5%)
                • Tachycardia (5%)
                • Pruritus, skin disorder, skin papilloma, urticaria (5%)

                Frequency Not Defined

                Tumor lysis syndrome

                Lymphoid malignancies

                Hypogammaglobulinemia

                Postmarketing Reports

                Hematologic: Prolonged pancytopenia, marrow hypoplasia, Grade 3-4 prolonged or late-onset neutropenia, hyperviscosity syndrome in Waldenstrom macroglobulinemia, prolonged hypogammaglobulinemia

                Cardiac: Fatal cardiac failure

                Immune/autoimmune events: Uveitis, optic neuritis, systemic vasculitis, pleuritis, lupus-like syndrome, serum sickness, polyarticular arthritis, and vasculitis with rash

                Infection: Viral infections, including progressive multifocal leukoencephalopathy (PML), increase in fatal infections in HIV-associated lymphoma, and a reported increased incidence of Grade 3 and 4 infections

                Neoplasia: Disease progression of Kaposi sarcoma

                Skin: Severe mucocutaneous reactions, pyoderma gangrenosum (including genital presentation)

                Gastrointestinal: Bowel obstruction and perforation

                Pulmonary: Fatal bronchiolitis obliterans and fatal interstitial lung disease

                Nervous system: Posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS)

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                Warnings

                Black Box Warnings

                Fatal infusion reaction

                • Can result in serious, including fatal reactions
                • Deaths within 24 hr of infusion have occurred
                • Approximately 80% of fatal infusion reactions occurred in association with the first infusion
                • Carefully monitor patients during infusion
                • In patients with NHL receiving rituximab monotherapy, grade 3 and 4 cytopenias reported; reactions included lymphopenia, neutropenia, leukopenia, anemia, and thrombocytopenia; discontinue infusion and provide medical treatment for grade 3 or 4 reactions

                Severe mucocutaneous reactions

                • Severe, including fatal, mucocutaneous reactions reported including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis

                Progressive multifocal leukoencephalopathy

                • John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy and death has been reported in patients treated with rituximab

                Hepatitis B virus reactivation

                • Reactivation of hepatitis B virus (HBV) infection reported, including deaths
                • Screen all patients for HBV infection before initiating drug by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc)
                • Consult with hepatitis experts regarding monitoring and use of HBV antiviral therapy when screening identifies patients at risk of HBV reactivation due to evidence of prior HBV infection
                • Monitor patients with evidence of prior HBV infection for clinical and laboratory signs of hepatitis B or HBV reactivation during therapy and for several months thereafter, since reactivations have occurred several months following completion of therapy
                • In patients who develop reactivation of HBV, immediately discontinue drug and start appropriate HBV treatment, also discontinue any chemotherapy until the HBV infection is controlled or resolved
                • Because of insufficient data, no recommendation can be made regarding the resumption of the drug in patients who develop HBV reactivation

                Contraindications

                None

                Cautions

                Severe, including fatal, infusion-related reactions may occur; severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes; premedicate as recommended according to indication; have appropriate medical management available if reaction occurs (eg, glucocorticoids, epinephrine, bronchodilators, oxygen) (see Black Box Warnings and Administration); methylprednisolone 100 mg intravenously or its equivalent recommended 30 min prior to each infusion

                Risk of potentially fatal mucocutaneous reactions (see Black Box Warnings)

                Increased risk of potentially fatal hepatitis B virus reactivation (see Black Box Warnings)

                Potential risk of progressive multifocal leukoencephalopathy (see Black Box Warnings)

                Risk of potentially fatal tumor lysis syndrome

                Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of therapy; not recommended for patients with severe, active infections

                Cardiac adverse reactions (eg, ventricular fibrillation, myocardial infarction, cardiogenic shock) may occur; discontinue infusions for serious or life-threatening cardiac arrhythmias; cardiac monitoring needed during and after all infusions patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

                Severe, including fatal, renal toxicity can occur after administration in patients with NHL; renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials; the combination of cisplatin and rituximab is not an approved treatment regimen

                Abdominal pain, bowel obstruction and perforation reported, including cases leading to death

                Based on human data, rituximab can cause fetal harm owing to B-cell lymphocytopenia in infants exposed in utero (see Pregnancy)

                Use in patients with rheumatoid arthritis who have not had prior inadequate response to more than 1 TNF antagonists is not recommended

                Hypogammaglobulinemia has been observed in pediatric patients treated with rituximab

                Majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant; patients with autoimmune diseases had prior or concurrent immunosuppressive therapy; most cases of PML were diagnosed within 12 months of their last infusion of rituximab

                Drug interaction overview

                • Safety of immunization with live viral vaccines following rituximab has not been studied and vaccination with live virus vaccines is not recommended before or during treatment; for patients with RA, follow current immunization guidelines and administer non-live vaccines at least 4 weeks before treatment
                • Limited data are available on the safety of the use of biologic agents or disease modifying antirheumatic drugs (DMARDs) other than methotrexate in RA patients exhibiting peripheral B-cell depletion following treatment; observe closely for signs of infection if biologic agents and/or DMARDs are used concomitantly
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                Pregnancy & Lactation

                Pregnancy

                Verify pregnancy status in females of reproductive potential prior to initiating therapy

                Based on human data, can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to rituximab in-utero

                Observe newborns and infants for signs of infection and manage accordingly

                Animal data

                • IV administration to pregnant cynomolgus monkeys during organogenesis caused lymphoid B-cell depletion in newborn offspring at doses resulting in 80% of exposure (based on AUC) of those achieved following a 2 gram-dose in humans
                • Advise pregnant females of the risk to a fetus

                Contraception

                • Females of childbearing potential: Use effective contraception during and for 12 months following treatment

                Lactation

                Data unavailable on drug presence in human milk, effects on breastfed children, or effects on milk production

                Detected in the milk of lactating cynomolgus monkeys, and IgG is present in human milk

                Rituximab reported to be excreted at low concentrations in human breast milk; given that clinical significance of this finding for children is not known, advise women not to breastfeed during treatment and for 6 months after last dose due to potential of serious adverse reactions in breastfed children

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Humanized monoclonal antibody, binds to CD20 antigen, inducing complement- or antibody-mediated cytolysis

                Absorption

                Peak plasma concentration (RA): 157 mcg/mL (first infusion); 183 mcg/mL (second infusion); 318 mcg/mL (2 x 500 mg); 381 mcg/mL (2 x 1000 mg)

                Distribution

                Vd: 3.1 L (RA); 4.5 L (GPA and MPA)

                Elimination

                Clearance: 0.335 L/day (RA); 0.312 L/day (GPA and MPA)

                Half-life

                • RA: 18 days
                • NHL: 22 days
                • CLL: 32 days
                • GPA and MPA: 23 days
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                Administration

                IV Compatibilities

                0.9% NaCl

                D5W

                IV Preparation

                Withdraw necessary amount of rituximab and dilute to a final concentration of 1-4 mg/mL into an infusion bag containing either 0.9% NaCl or D5W

                Visually inspect vials, solution should appear clear and colorless, do not use vial if particular is present

                Gently invert the bag to mix the solution

                Do not mix with other drugs

                Discard any unused portion left in the vial

                Premedication

                Before each infusion: Premedicate with acetaminophen and an antihistamine; add glucocorticoid as per the following recommendations

                Rapid 90-min infusion: Administer glucocorticoid component of the chemotherapy regimen before infusion

                RA, GPA, MPA, PV: Methylprednisolone 100 mg IV (or equivalent) 30 minutes before each infusion

                PCP and herpes virus prophylaxis

                • Consider antiviral prophylaxis to prevent hepatitis B reactivation for all patients receiving rituximab (oncology and non-oncology indications) with resolved hepatitis B virus infection
                • PCP prophylaxis
                  • CLL: During and for up to 12 months following treatment as appropriate
                  • GPA and MPA: During and for up to 6 months following final infusion
                  • PV: Consider during and following treatment

                IV Administration

                Administer IV infusion only; do not give IV push or bolus

                First infusion

                • Initiate infusion rate at 50 mg/hr; if no infusion reaction, increase infusion rate by 50 mg/hr increments q30min, to a maximum of 400 mg/hr

                Subsequent infusions

                • Standard infusions
                  • Initiate infusion rate at 100 mg/hr; if no infusion reaction, increase rate by 100 mg/hr increments at q30min, to a maximum of 400 mg/hr
                • Patients with previously untreated follicular NHL and DLBCL
                  • No Grade 3 or 4 infusion-related events during Cycle 1: Infuse over 90 min during Cycle 2 with a glucocorticoid-containing chemotherapy regimen
                  • Do NOT administer 90-min infusions to patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count ≥5,000/mm3 before Cycle 2
                  • Initiate rate of 20% of total dose given in the first 30 min and remaining 80% given over the next 60 min
                  • If 90-minute infusion tolerated in Cycle 2, administer the same rate for remaining treatment cycles (through Cycle 6 or 8)
                  • Interrupt infusion or slow infusion rate for IRR; continue infusion at one-half the previous rate upon improvement of symptoms

                Storage

                IV

                • Unused vials: Refrigerate at 2-8°C (36-46°F); protect vials from direct sunlight
                • Diluted solutions: Store at 2-8°C (36-46°F) for 24 hr; shown also be stable for additional 24 hr at room temperature
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Rituxan intravenous
                -
                10 mg/mL vial
                Rituxan intravenous
                -
                10 mg/mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                rituximab intravenous

                RITUXIMAB - INJECTION

                (ri-TUX-i-mab)

                COMMON BRAND NAME(S): Rituxan, Ruxience, Truxima

                WARNING: Rituximab may rarely cause serious (sometimes fatal) side effects including severe breathing problems or heart problems (such as heart attack, irregular heartbeat). If these serious side effects occur, they usually happen during the first treatment with rituximab. Your doctor will carefully watch you during treatment and may stop or slow down your treatment if you have any signs of a reaction. Get medical help right away if you have trouble breathing, itching, swelling (especially of the throat/lips), dizziness, fast/slow/irregular heartbeat, or chest pain.Rarely, people using this medication have had serious (sometimes fatal) skin reactions (such as Stevens-Johnson syndrome). Get medical help right away if you develop any rash, blisters, peeling skin, or sores on your skin, lips, or in your mouth.This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.Rituximab may cause serious (possibly fatal) liver disease in people who have a current or past infection with hepatitis B. This may occur during treatment or up to 2 years after treatment is finished. Before starting this medication, tell your doctor if you have ever had hepatitis B. Your doctor should order a test to see if you have the hepatitis B infection before starting treatment. Tell your doctor right away if you have symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, or dark urine.

                USES: Rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). It works by slowing or stopping the growth of cancer cells.Some brands of rituximab are also used to treat rheumatoid arthritis and can decrease joint pain and swelling. This drug is also used to treat certain types of blood vessel disease (such as granulomatosis with polyangiitis, microscopic polyangiitis) and can decrease the swelling of the blood vessels. Rituximab is also used to treat a certain skin condition (pemphigus vulgaris). It helps to reduce the number of skin lesions.This monograph is about the following rituximab products: rituximab, rituximab-abbs, rituximab-arrx, and rituximab-pvvr.

                HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using rituximab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Your doctor should prescribe other medications (such as acetaminophen, an antihistamine, methylprednisolone) for you to take before each treatment to help reduce side effects, such as fever and chills. Carefully follow your doctor's instructions.This medication is given by slow injection into a vein by a health care professional as directed by your doctor. The dosage and treatment schedule are based on your medical condition, body size, and response to treatment.

                SIDE EFFECTS: See also Warning section.Nausea, vomiting, headache, dizziness, joint/muscle pain, weakness, or flushing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: swelling hands/ankles/feet, increased thirst/urination, numbness/tingling of arms/legs.Rituximab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.This medication can decrease blood cells, which can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds, signs of an infection (such as sore throat that doesn't go away, fever, chills), unusual tiredness, pale skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using rituximab, tell your doctor or pharmacist if you are allergic to it; or to any rituximab products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, heart problems (such as irregular heartbeat, previous heart attack), bleeding/blood disorders, current/recent infections.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Rituximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be at greater risk for heart problems (such as irregular heartbeat) or lung problems while using this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using rituximab. Rituximab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 1 year after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.This drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 6 months after treatment is not recommended. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: other drugs that weaken the immune system/increase the risk of infection (such as tofacitinib, natalizumab, fingolimod).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Lab and/or medical tests (such as complete blood count, hepatitis B virus, kidney/liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.