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Rituxan (Rituximab) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

INITIAL THERAPY:

RITUXAN is given at 375 mg/m2 IV infusion once weekly for 4 or 8 doses.

Retreatment Therapy:    Patients who subsequently develop progressive disease may be safely retreated with RITUXAN 375 mg/m2 IV infusion once weekly for 4 doses. Currently there are limited data concerning more than 2 courses.

RITUXAN as a Component of Zevalin™ (Ibritumomab Tiuxetan) Therapeutic Regimen:    As a required component of the Zevalin therapeutic regimen, RITUXAN 250 mg/m2 should 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 2-8°C (36-46°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 (2-8°C). No incompatibilities between RITUXAN and polyvinylchloride or polyethylene bags have been observed.

ADMINISTRATION: DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.

Infusion and hypersensitivity reactions may occur (see BOX WARNINGS, WARNINGS, and ADVERSE REACTIONS). Premedication consisting of acetaminophen and diphenhydramine 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 hypersensitivity or 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 a hypersensitivity (non-IgE-mediated) or an infusion reaction develops, the infusion should be temporarily slowed or interrupted (see BOX 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 2-8°C (36-46°F). Do not use beyond expiration date stamped on carton. RITUXAN vials should be protected from direct sunlight. Refer to the "Preparation and Administration" section for information on the stability and storage of solutions of RITUXAN diluted for infusion.

HOW SUPPLIED

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

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