Non-Hodgkin's Lymphoma

Rituxan® (Rituximab) is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma.

Rituxan® (Rituximab) is indicated for the first-line treatment of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP chemotherapy.

Rituxan® (Rituximab) is indicated for the treatment of low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.

Rituxan® (Rituximab) is indicated for the first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens.

Rheumatoid Arthritis

Rituxan® (Rituximab) in combination with methotrexate is indicated to reduce signs and symptoms in adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell Non-Hodgkin's Lymphoma

The recommended dose of Rituxan is 375 mg/m² IV infusion once weekly for 4 or 8 doses.

Retreatment Therapy

The recommended dose of Rituxan is 375 mg/m² IV infusion once weekly for 4 doses in responding patients who develop progressive disease after previous Rituxan therapy. Currently there are limited data concerning more than 2 courses.

Previously Untreated, Follicular, CD20-Positive, B-Cell NHL

The recommended dose of Rituxan is 375 mg/m² IV infusion, given on Day 1 of each cycle of CVP chemotherapy, for up to 8 doses.

Previously Untreated, Low-Grade, CD20-Positive, B-Cell NHL

The recommended dose of Rituxan in patients who have not progressed following 6-8 cycles of CVP chemotherapy is 375 mg/m² IV infusion, once weekly for 4 doses every 6 months for up to 16 doses.

Diffuse Large B-Cell NHL

The recommended dose of Rituxan is 375 mg/m² IV per infusion given on Day 1 of each cycle of chemotherapy for up to 8 infusions.

Rheumatoid Arthritis

Rituxan is given as two-1000 mg IV infusions separated by 2 weeks. Glucocorticoids administered as methylprednisolone 100 mg IV or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions. Safety and efficacy of retreatment have not been established in controlled trials (see PRECAUTIONS: Retreatment in patients with RA).

Rituxan is given in combination with methotrexate.

Rituxan as a Component of Zevalin® (Ibritumomab tiuxetan) Therapeutic Regimen

As a required component of the Zevalin therapeutic regimen, Rituxan 250 mg/m²should be infused within 4 hours prior to the administration of Indium-111- (In-111-) Zevalin and within 4 hours prior to the administration of Yttrium-90- (Y-90-) Zevalin. Administration of Rituxan and In-111-Zevalin should precede Rituxan and Y-90-Zevalin by 7-9 days. Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen.

Rituxan may be administered in an outpatient setting. DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS. (See Administration).

Instructions for Administration

Preparation for Administration

Use appropriate aseptic technique. Withdraw the necessary amount of Rituxan and dilute to a final concentration of 1 to 4 mg/mL into an infusion bag containing either 0.9% Sodium Chloride, USP, or 5% Dextrose in Water, USP. Gently invert the bag to mix the solution. Discard any unused portion left in the vial. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Rituxan solutions for infusion may be stored at 2°C–8°C (36°F–46°F) for 24 hours. Rituxan solutions for infusion have been shown to be stable for an additional 24 hours at room temperature. However, since Rituxan solutions do not contain a preservative, diluted solutions should be stored refrigerated (2°C–8°C). No incompatibilities between Rituxan and polyvinylchloride or polyethylene bags have been observed.

Administration

DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS

Infusion reactions may occur (see BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS). Premedication consisting of acetaminophen and an antihistamine should be considered before each infusion of Rituxan. Premedication may attenuate infusion reactions. Since transient hypotension may occur during Rituxan infusion, consideration should be given to withholding antihypertensive medications 12 hours prior to Rituxan infusion.

First Infusion

The Rituxan solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Rituxan should not be mixed or diluted with other drugs. If infusion reactions do not occur, escalate the infusion rate in 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. If an infusion reaction develops, the infusion should be temporarily slowed or interrupted (see BOXED WARNINGS and WARNINGS). The infusion can continue at one-half the previous rate upon improvement of patient symptoms.

Subsequent Infusions

If the patient tolerated the first infusion well, subsequent Rituxan infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated. If the patient did not tolerate the first infusion well, follow the guidelines under First Infusion.

Stability and Storage

Rituxan vials are stable at 2°C–8°C (36°F–46°F). Do not use beyond expiration date stamped on carton. Rituxan vials should be protected from direct sunlight. Do not freeze or shake. Refer to the “Preparation for Administration” section for information on the stability and storage of solutions of Rituxan diluted for infusion.

Rituxan® (Rituximab) is supplied as 100 mg and 500 mg of sterile, preservative-free, single-use vials.

Single unit 100 mg carton: Contains one 10 mL vial of Rituxan (10 mg/mL).

NDC 50242-051-21

Single unit 500 mg carton: Contains one 50 mL vial of Rituxan (10 mg/mL).

NDC 50242-053-06

Jointly Marketed by: Biogen Idec Inc., and Genentech, Inc. Manufactured by: Genentech, Inc., 1 DNA Way, San Francisco, CA 94080-4990 4835502
Revision Date August 22, 2007. FDA rev date: 8/22/2007

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