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-related reactions. Severe reactions typically occurred during the first infusion, with time to onset of 30 to 120 minutes 
  • RITUXAN-induced infusion-related 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-related reactions as needed. Depending on the severity of the infusion-related 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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