- Arthritis/rheumatic disorders
- Leukemias, lymphomas, and other hematologic cancers
- Miscellaneous immune disorders
Arthritis/rheumatic disorders:
Indications for: TRUXIMA
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.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.
TRUXIMA 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 Classification:
CD20-directed cytolytic monoclonal antibody.
TRUXIMA 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.
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.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (10mL, 50mL)—1
Leukemias, lymphomas, and other hematologic cancers:
Indications for: TRUXIMA
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.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.
TRUXIMA 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 Classification:
CD20-directed cytolytic monoclonal antibody.
TRUXIMA 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.
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.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (10mL, 50mL)—1
Miscellaneous immune disorders:
Indications for: TRUXIMA
Treatment of granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) and microscopic polyangiitis (MPA), in combination with glucocorticoids.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.
TRUXIMA 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 Classification:
CD20-directed cytolytic monoclonal antibody.
TRUXIMA 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.
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.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (10mL, 50mL)—1
