RITUXAN—ESTABLISHED DOSING REGIMENS FOR TREATMENT SETTINGS IN NHL AND CLL

*In PRIMA, patients were randomized to receive either RITUXAN or no further therapy if they achieved a CR/CRu or PR with R-CHEMO induction therapy. In ECOG 1496, patients were randomized to receive either RITUXAN or no further therapy if they achieved a CR, PR, or SD with CVP induction therapy. 1 
R-CHEMO: Approximately 75% of trial patients in both trial arms received R-CHOP, 22% received R-CVP, and 3% received R-FCM. 1

Diffuse Large B-Cell NHL (DLBCL) 1

Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens.

RITUXAN is not recommended for use in patients with severe, active infections.

  • The dose of RITUXAN is 375 mg/m2 IV infusion given on Day 1 of each cycle of chemotherapy for up to 8 doses 

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Previously Untreated Follicular, B-Cell NHL 1

Previously untreated follicular, CD20-positive, 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.

RITUXAN is not recommended for use in patients with severe, active infections.

  • The dose of RITUXAN in combination with first-line chemotherapy is 375 mg/m2 IV infusion, given on Day 1 of each cycle of chemotherapy, for up to 8 doses 
  • The dose of RITUXAN in patients achieving a complete or partial response is 375 mg/m2 IV infusion, given 8 weeks after the completion of RITUXAN in combination with chemotherapy, every 8 weeks, for up to 12 doses

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Non-Progressing, Low-Grade, B-Cell NHL 1

Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy.

RITUXAN is not recommended for use in patients with severe, active infections.

  • The dose of RITUXAN in patients who have not progressed following six to eight cycles of CVP chemotherapy is 375 mg/mIV infusion once weekly for 4 weeks, every 6 months, for up to 16 doses

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Relapsed Or Refractory, Low-Grade Or Follicular, B-Cell NHL 1

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.

RITUXAN is not recommended for use in patients with severe, active infections.

  • The dose of RITUXAN is 375 mg/m2 IV infusion once weekly for 4 or 8 doses 

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Chronic Lymphocytic Leukemia (CLL) 1

In combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL. 1

RITUXAN is not recommended for use in patients with severe, active infections.

  • The dose of RITUXAN is 375 mg/m2 IV infusion the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2−6 (every 28 days)

RITUXAN is not approved as monotherapy in CLL.

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SELECT IMPORTANT SAFETY INFORMATION

Infusion Reactions
  • RITUXAN can cause severe, including fatal, infusion reactions. Severe reactions typically occurred during the first infusion, with time to onset of 30 to 120 minutes 
  • RITUXAN-induced infusion reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death
  • Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed. Depending on the severity of the infusion reaction and the required interventions, slow the infusion rate, interrupt the infusion, or permanently discontinue RITUXAN. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved
  • Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm3)

NHL=non-Hodgkin's lymphoma; CLL=chronic lymphocytic leukemia; DLBCL=diffuse large B-cell lymphoma; R=RITUXAN; CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone; CVP=cyclophosphamide, vincristine, and prednisone; FC=fludarabine and cyclophosphamide; FCM=fludarabine, cyclophosphamide, and mitoxantrone.

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