Generic Name and Formulations:
Rituximab 10mg/mL; soln for IV infusion; preservative-free.
Company:
Genentech, Inc.
In combination with methotrexate (MTX): to reduce signs/symptoms and inhibit progression of structural damage in moderately-to-severely active rheumatoid arthritis patients who have had an inadequate response to one or more TNF antagonist therapies.
Give glucocorticoids 30 minutes prior to each infusion. In combination with MTX: give two 1000mg IV infusions separated by 2 weeks. Subsequent courses should be given every 24 weeks or based on response, but not sooner than every 16 weeks.
Not recommended.
B-lymphocyte-restricted differentiation antigen [CD20] inhibitor.
Severe, active infections: not recommended. Discontinue if severe infusion or mucocutaneous reactions occur (eg, hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis). Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Pre-existing cardiovascular disease; monitor during and after treatment. Hepatitis B reactivation with fulminant hepatitis may occur; monitor for signs of active HBV infection, discontinue if occurs. Monitor CBCs, platelet counts at 2-4 month intervals during treatment, then periodically. Concomitant biologic agents and DMARDs except MTX: monitor for infections. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Live virus vaccines: not recommended. Renal toxicity with cisplatin.
Fever, chills, rigors, nausea, pruritus, angioedema, asthenia, hypotension, headache, bronchospasm, throat irritation, rhinitis, urticaria, rash, vomiting, myalgia, dizziness, hypertension, cough, flushing, chest tightness; myelosuppression (eg, lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia), infusion reactions (may be fatal), mucocutaneous reactions (may be fatal), progressive multifocal leukoencephalopathy, viral infections (discontinue if serious), tumor lysis syndrome, renal toxicity, bowel obstruction/perforation, hepatitis B reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious).
Single-use vial (10mL, 50mL)—1
Relapsed or refractory, low-grade or follicular, CD20(+), B-cell non-Hodgkin's lymphoma (NHL). Previously untreated follcular, CD20(+), B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan 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.
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 infusion rate in 50mg/hr increments every 30 minutes. Subsequent infusions: initially at a rate of 100mg/hr; may increase infusion rate in 100mg/hr increments every 30 minutes. 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 CVP chemotherapy for up to 8 doses. In patients with complete or partial response, initiate Rituxan maintenance 8 weeks following completion of Rituxan in combination with chemotherapy. Administer Rituxan as a single-agent every 8 weeks for 12 doses. Low-grade, CD20(+), B-cell NHL: 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 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.
Not recommended.
B-lymphocyte-restricted differentiation antigen [CD20] inhibitor.
Severe, active infections: not recommended. Discontinue if severe infusion or mucocutaneous reactions occur (eg, hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis). Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Pre-existing cardiovascular disease; monitor during and after treatment. Hepatitis B reactivation with fulminant hepatitis may occur; monitor for signs of active HBV infection, discontinue if occurs. Monitor CBCs, platelet counts during treatment, then periodically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Live virus vaccines: not recommended. Renal toxicity with cisplatin.
Fever, chills, rigors, nausea, pruritus, angioedema, asthenia, hypotension, headache, bronchospasm, throat irritation, rhinitis, urticaria, rash, vomiting, myalgia, dizziness, hypertension, cough, flushing, chest tightness; myelosuppression (eg, lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia), infusion reactions (may be fatal), mucocutaneous reactions (may be fatal), progressive multifocal leukoencephalopathy, viral infections (discontinue if serious), tumor lysis syndrome, renal toxicity, bowel obstruction/perforation, hepatitis B reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious).
Testing considerations: FCGR3A genotype testing
Single-use vial (10mL, 50mL)—1
For the treatment of Wegener's granulomatosis and microscopic polyangiitis, in combination with glucocorticoids.
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 infusion rate in 50mg/hr increments every 30 minutes. Subsequent infusions: initially at a rate of 100mg/hr; may increase infusion rate in 100mg/hr increments every 30 minutes. Both: max 400mg/hr if infusion reactions do not occur. 375mg/m2 once weekly for 4 weeks. Begin glucocorticoids within 14 days prior to or with initiation of Rituxan and continue during and after the 4 week course (see full labeling). PCP prophylaxis recommended during and for at least 6 months following last infusion. Retreatment: safety and efficacy not established.
Not recommended.
B-lymphocyte-restricted differentiation antigen [CD20] inhibitor.
Severe, active infections: not recommended. Discontinue if severe infusion or mucocutaneous reactions occur (eg, hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis). Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Pre-existing cardiovascular disease; monitor during and after treatment. Hepatitis B reactivation with fulminant hepatitis may occur; monitor for signs of active HBV infection, discontinue if occurs. Monitor CBCs, platelet counts at 2-4 month intervals during treatment, then periodically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Live virus vaccines: not recommended. Renal toxicity with cisplatin. Concomitant immunosuppressants other than corticosteroids have not been studied.
Infections, GI upset, headache, muscle spasms, anemia, peripheral edema; myelosuppression (eg, lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia), infusion reactions (may be fatal), mucocutaneous reactions (may be fatal), progressive multifocal leukoencephalopathy, viral infections (discontinue if serious), tumor lysis syndrome, renal toxicity, bowel obstruction/perforation, hepatitis B reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious).
Single-use vial (10mL, 50mL)—1