"The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.
Rituxan, an anti-cancer drug, is intended fo"...
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Non–Hodgkin's Lymphoma (NHL)
Rituxan® (rituximab) is indicated for the treatment of patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- 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.
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
Chronic Lymphocytic Leukemia (CLL)
Rituxan® (rituximab) is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.
Rheumatoid Arthritis (RA)
Rituxan® (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
Limitations of Use
Rituxan is not recommended for use in patients with severe, active infections.
DOSAGE AND ADMINISTRATION
Administer only as an Intravenous Infusion [see Recommended Concomitant Medications].
Do not administer as an intravenous push or bolus.
Premedicate before each infusion [see Recommended Concomitant Medications].
Rituxan should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur [see WARNINGS AND PRECAUTIONS].
- First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
- Subsequent Infusions:
Standard Infusion: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr.
For previously untreated follicular NHL and DLBCL patients:
If patients did not experience a Grade 3 or 4 infusion related adverse event during Cycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen.
Initiate at a rate of 20% of the total dose given in the first 30 minutes and the remaining 80% of the total dose given over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used when administering the remainder of the treatment regimen (through Cycle 6 or 8).
Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count ≥ 5000/mm³ before Cycle 2 should not be administered the 90-minute infusion [see Clinical Studies].
- Interrupt the infusion or slow the infusion rate for infusion reactions [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. Continue the infusion at one-half the previous rate upon improvement of symptoms.
Recommended Dose for Non-Hodgkin's Lymphoma (NHL)
The recommended dose is 375 mg/m² as an intravenous infusion according to the following schedules:
- Relapsed or Refractory, Low-Grade or Follicular,
CD20-Positive, B-Cell NHL
Administer once weekly for 4 or 8 doses.
- Retreatment for Relapsed or Refractory, Low-Grade or
Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 doses.
- Previously Untreated, Follicular, CD20-Positive,
Administer on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate Rituxan maintenance eight weeks following completion of Rituxan in combination with chemotherapy. Administer Rituxan as a single-agent every 8 weeks for 12 doses.
- Non-progressing, Low-Grade, CD20-Positive, B-cell NHL,
after first-line CVP chemotherapy
Following completion of 6-8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
- Diffuse Large B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions.
Recommended Dose for Chronic Lymphocytic Leukemia (CLL)
The recommended dose is:
- 375 mg/m² the day prior to the initiation of FC chemotherapy, then 500 mg/m² on Day 1 of cycles 2-6 (every 28 days).
Recommended Dose as a Component of Zevalin®
- Infuse rituximab 250 mg/m² 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.
- Administer Rituxan and In-111-Zevalin 7-9 days prior to Rituxan and Y-90- Zevalin.
- Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen.
Recommended Dose for Rheumatoid Arthritis (RA)
- Administer Rituxan as two-1000 mg intravenous infusions separated by 2 weeks.
- Glucocorticoids administered as methylprednisolone 100 mg intravenous or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions.
- Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.
- Rituxan is given in combination with methotrexate.
Recommended Dose for Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
- Administer Rituxan as a 375 mg/m² intravenous infusion once weekly for 4 weeks.
- Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of Rituxan and may continue during and after the 4 week course of Rituximab treatment.
- Safety and efficacy of treatment with subsequent courses of Rituxan have not been established [see WARNINGS AND PRECAUTIONS].
Recommended Concomitant Medications
Premedicate before each infusion with acetaminophen and an antihistamine. For patients administered Rituxan according to the 90-minute infusion rate, the glucocorticoid component of their chemotherapy regimen should be administered prior to infusion [see Clinical Studies].
For RA patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion.
For GPA and MPA patients, glucocorticoids are given in combination with Rituxan.
PCP prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last Rituxan infusion.
Preparation for Administration
Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use vial if particulates or discoloration is present. Withdraw the necessary amount of Rituxan and dilute to a final concentration of 1 to 4 mg/mL in an infusion bag containing either 0.9% Sodium Chloride, USP, or 5% Dextrose in Water, USP. Gently invert the bag to mix the solution. Do not mix or dilute with other drugs. Discard any unused portion left in the vial.
Dosage Forms And Strengths
100 mg/10 mL single-use vial
500 mg/50 mL single-use vial
Storage And Handling
Rituxan vials [100 mg/10 mL single-use vials (NDC 50242-051-21) and 500 mg/50 mL single-use vials (NDC 50242-053-06)] 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.
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.
RITUXAN® [rituximab] Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990. Revision Date: September 2013
Last reviewed on RxList: 10/21/2013
This monograph has been modified to include the generic and brand name in many instances.
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