Monograph Details
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Neoplasms
> Monoclonal antibodies
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RITUXAN |
| Manufacturer |
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Genentech, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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B-lymphocyte-restricted differentiation antigen [CD20] inhibitor. |
| Generic Name |
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Rituximab 10mg/mL; soln for IV infusion; preservative-free. |
| Indications |
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Relapsed or refractory, low-grade or follicular, CD20(+), B-cell non-Hodgkin's lymphoma (NHL). First-line treatment of follicular, CD20(+), B-cell NHL in combination with CVP chemotherapy. Low-grade, CD20(+), B-cell NHL in patients with stable disease or who achieve a partial or complete reponse following 1st line treatment with CVP regimen. First-line treatment of diffuse large B-cell, CD20(+) NHL in combination with CHOP or other anthracycline-based chemotherapy regimens. |
| Children |
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Not recommended. |
| Adults |
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Give by IV infusion initially at a rate of 50mg/hr; may increase infusion rate in 50mg/hr increments every 30 minutes to a max of 400mg/hr if infusion reactions do not occur. NHL: 375mg/m2 once weekly for 4–8 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. Previously untreated, 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. As a component of Zevalin regimen: see literature. |
| Precautions |
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Discontinue if severe infusion or mucocutaneous reactions occur (eg, hypoxia, pulmonary infiltrates, acute respiratory stress disorder, 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). 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. |
| Interactions |
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Avoid live virus vaccines. Renal toxicity with cisplatin. |
| Adverse Reactions |
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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, tumor lysis syndrome, renal toxicity, bowel obstruction/perforation, hepatitis B reactivation with fulminant hepatitis, cardiac arrhythmias. |
| How Supplied |
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Single-use vial (10mL, 50mL)—1 |
| Additional Resources |
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• Related Prescribing Note |
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