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Truxima Generic Name & Formulations
Legal Class
Rx
General Description
Rituximab-abbs 10mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
CD20-directed cytolytic monoclonal antibody.
How Supplied
Single-dose vial (10mL, 50mL)—1
Manufacturer
Generic Availability
NO
Truxima Indications
Indications
In combination with methotrexate (MTX): for the treatment of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more TNF antagonist therapies.
Truxima Dosage and Administration
Adult
Give by IV infusion. Give glucocorticoids 30mins prior to each infusion. First infusion: initially at a rate of 50mg/hr; may increase by 50mg/hr increments every 30mins. Subsequent infusions: initially at a rate of 100mg/hr; may increase by 100mg/hr increments every 30mins. Both: max 400mg/hr if infusion reactions do not occur. In combination with MTX: two 1000mg separated by 2 weeks. Subsequent courses should be given every 24 weeks or based on response, but not sooner than every 16 weeks.
Children
Not established.
Truxima Contraindications
Not Applicable
Truxima Boxed Warnings
Boxed Warning
Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.
Truxima Warnings/Precautions
Warnings/Precautions
Discontinue if severe infusion-related or mucocutaneous reactions occur (eg, urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, anaphylactoid events, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid or vesiculobullous dermatitis, toxic epidermal necrolysis). Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Discontinue if SCr rises or oliguria occurs. Severe, active infections: not recommended. Discontinue and treat if serious infections (eg, bacterial, fungal, viral) occur. Pre-existing cardiovascular or pulmonary disease, high circulating malignant cells; monitor closely. Monitor CBCs, platelet counts prior to each dose and during therapy, then periodically as indicated. Monitor for cytopenias. Update vaccination status prior to initiation. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥12 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥6 months after the last dose).
Truxima Pharmacokinetics
See Literature
Truxima Interactions
Interactions
Concomitant live virus vaccines: not recommended. Give non-live vaccines at least 4 weeks prior to Truxima. Concomitant biologics/DMARDs; monitor for infection. Concomitant immunosuppressants other than corticosteroids have not been studied. Renal toxicity with concomitant cisplatin.
Truxima Adverse Reactions
Adverse Reactions
Infusion-related reactions (may be fatal), fever, lymphopenia, chills, infections (may be serious), asthenia, CV events; mucocutaneous reactions (may be fatal), PML, tumor lysis syndrome, renal toxicity, HBV reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious). Also with concomitant chemotherapy: bowel obstruction and perforation; evaluate if abdominal pain or persistent vomiting occur.
Truxima Clinical Trials
See Literature
Truxima Note
Not Applicable
Truxima Patient Counseling
See Literature
Truxima Generic Name & Formulations
Legal Class
Rx
General Description
Rituximab-abbs 10mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
CD20-directed cytolytic monoclonal antibody.
How Supplied
Single-dose vial (10mL, 50mL)—1
Manufacturer
Generic Availability
NO
Truxima Indications
Indications
Relapsed or refractory, low-grade or follicular, CD20(+), B-cell non-Hodgkin's lymphoma (NHL). Previously untreated follicular, CD20(+), B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20(+), B-cell NHL as a single agent after first-line CVP chemotherapy. Previously untreated diffuse large B-cell, CD20(+) NHL (DLBCL) in combination with CHOP or other anthracycline-based chemotherapy regimens. CD20(+) chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.
Truxima Dosage and Administration
Adult
Give by IV infusion. Premedicate with an antihistamine and acetaminophen prior to each infusion. First infusion: initially at a rate of 50mg/hr; may increase by 50mg/hr increments every 30mins. Subsequent infusions: initially at a rate of 100mg/hr; may increase by 100mg/hr increments every 30mins. Both: max 400mg/hr if infusion reactions do not occur. Previously untreated follicular NHL and DLBCL patients: if no Grade 3 or 4 infusion related adverse events during Cycle 1, a 90-minute infusion may be given in Cycle 2 with a glucocorticoid-containing chemotherapy regimen (see full labeling). NHL: 375mg/m2 once weekly for 4 or 8 doses. Retreatment therapy: 375mg/m2 once weekly for 4 doses. Previously untreated, follicular, CD20(+), B-cell NHL: 375mg/m2 on Day 1 of each cycle of chemotherapy for up to 8 doses. In patients with complete or partial response, initiate Truxima maintenance 8 weeks following completion of Truxima in combination with chemotherapy. Administer Truxima as a single-agent every 8 weeks for 12 doses. Non-progressing, low-grade, CD20(+), B-cell NHL after CVP chemotherapy: 375mg/m2 once weekly for 4 doses every 6 months for up to 16 doses. Diffuse large B-cell NHL: 375mg/m2 on Day 1 of each chemotherapy cycle for up to 8 infusions. CLL: 375mg/m2 the day prior to FC chemotherapy, then 500mg/m2 on Day 1 of cycles 2–6 (every 28 days). Give PCP and antiherpetic viral prophylaxis during and up to 12 months after CLL therapy. As a component of Zevalin regimen: see full labeling.
Children
Not established.
Truxima Contraindications
Not Applicable
Truxima Boxed Warnings
Boxed Warning
Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.
Truxima Warnings/Precautions
Warnings/Precautions
Discontinue if severe infusion-related or mucocutaneous reactions occur (eg, urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, anaphylactoid events, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid or vesiculobullous dermatitis, toxic epidermal necrolysis). Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Discontinue if SCr rises or oliguria occurs. Severe, active infections: not recommended. Discontinue and treat if serious infections (eg, bacterial, fungal, viral) occur. Pre-existing cardiovascular or pulmonary disease, high circulating malignant cells; monitor closely. Monitor CBCs, platelet counts prior to each dose and during therapy, then periodically as indicated. Monitor for cytopenias. Update vaccination status prior to initiation. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥12 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥6 months after the last dose).
Truxima Pharmacokinetics
See Literature
Truxima Interactions
Interactions
Concomitant live virus vaccines: not recommended. Give non-live vaccines at least 4 weeks prior to Truxima. Concomitant biologics/DMARDs; monitor for infection. Concomitant immunosuppressants other than corticosteroids have not been studied. Renal toxicity with concomitant cisplatin.
Truxima Adverse Reactions
Adverse Reactions
Infusion-related reactions (may be fatal), fever, lymphopenia, chills, infections (may be serious), asthenia, CV events; mucocutaneous reactions (may be fatal), PML, tumor lysis syndrome, renal toxicity, HBV reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious). Also with concomitant chemotherapy: bowel obstruction and perforation; evaluate if abdominal pain or persistent vomiting occur.
Truxima Clinical Trials
See Literature
Truxima Note
Not Applicable
Truxima Patient Counseling
See Literature
Truxima Generic Name & Formulations
Legal Class
Rx
General Description
Rituximab-abbs 10mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
CD20-directed cytolytic monoclonal antibody.
How Supplied
Single-dose vial (10mL, 50mL)—1
Manufacturer
Generic Availability
NO
Truxima Indications
Indications
Treatment of granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) and microscopic polyangiitis (MPA), in combination with glucocorticoids.
Truxima Dosage and Administration
Adult
Give by IV infusion. Premedicate with an antihistamine and acetaminophen prior to each infusion. First infusion: initially at a rate of 50mg/hr; may increase by 50mg/hr increments every 30mins. Subsequent infusions: initially at a rate of 100mg/hr; may increase by 100mg/hr increments every 30mins. Both: max 400mg/hr if infusion reactions do not occur. Induction: 375mg/m2 once weekly for 4 weeks. Begin glucocorticoids within 14 days prior to or with initiation of Truxima and continue during and after the 4 week course (see full labeling). Follow-up treatment (in patients who achieved disease control with induction therapy): initiate within 24 weeks after last rituximab product induction dose or as clinically indicated, but no sooner than 16 weeks after last induction infusion; or within the 4 week period after disease controlled with other immunosuppressants. 500mg once, followed by second 500mg 2 weeks later, then 500mg every 6 months thereafter as clinically indicated. Give glucocorticoids 30mins before each infusion (see full labeling). PCP prophylaxis recommended during and for at least 6 months following last infusion.
Children
Not established.
Truxima Contraindications
Not Applicable
Truxima Boxed Warnings
Boxed Warning
Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.
Truxima Warnings/Precautions
Warnings/Precautions
Discontinue if severe infusion-related or mucocutaneous reactions occur (eg, urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, anaphylactoid events, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid or vesiculobullous dermatitis, toxic epidermal necrolysis). Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Discontinue if SCr rises or oliguria occurs. Severe, active infections: not recommended. Discontinue and treat if serious infections (eg, bacterial, fungal, viral) occur. Pre-existing cardiovascular or pulmonary disease, high circulating malignant cells; monitor closely. Monitor CBCs, platelet counts prior to each dose and during therapy, then periodically as indicated. Monitor for cytopenias. Update vaccination status prior to initiation. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥12 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥6 months after the last dose).
Truxima Pharmacokinetics
See Literature
Truxima Interactions
Interactions
Concomitant live virus vaccines: not recommended. Give non-live vaccines at least 4 weeks prior to Truxima. Concomitant biologics/DMARDs; monitor for infection. Concomitant immunosuppressants other than corticosteroids have not been studied. Renal toxicity with concomitant cisplatin.
Truxima Adverse Reactions
Adverse Reactions
Infusion-related reactions (may be fatal), fever, lymphopenia, chills, infections (may be serious), asthenia, CV events; mucocutaneous reactions (may be fatal), PML, tumor lysis syndrome, renal toxicity, HBV reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious). Also with concomitant chemotherapy: bowel obstruction and perforation; evaluate if abdominal pain or persistent vomiting occur.
Truxima Clinical Trials
See Literature
Truxima Note
Not Applicable
Truxima Patient Counseling
See Literature
