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Uses

Non-Hodgkin’s Lymphoma

Treatment of relapsed or refractory low-grade or follicular, antigen CD20-positive, B-cell non-Hodgkin’s lymphoma.

First-line treatment of follicular, antigen CD20-positive, B-cell non-Hodgkin’s lymphoma; used in combination with CVP (cyclophosphamide, vincristine, and prednisone) chemotherapy.

Treatment of low-grade, antigen CD20-positive, B-cell non-Hodgkin’s lymphoma in patients with stable disease or a partial or complete response following first-line treatment with CVP chemotherapy.

First-line treatment of diffuse large B-cell, antigen CD20-positive, non-Hodgkin’s lymphoma; used in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy.

Being investigated for the treatment of advanced-stage low-grade or follicular non-Hodgkin’s lymphoma in conjunction with combination chemotherapy (e.g., initial therapy† in combination with CHOP).

Designated an orphan drug by FDA for the treatment of non-Hodgkin’s lymphoma.

Used as a required component of a radioimmunotherapeutic regimen for relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma that is refractory to rituximab therapy; used in conjunction with ibritumomab tiuxetan, a radioimmunotherapeutic agent. Rituximab is used prior to each dose of ibritumomab to deplete peripheral B cells and to improve distribution of the radioimmunotherapeutic agent.

Rheumatoid Arthritis

Used in conjunction with methotrexate to manage the signs and symptoms of rheumatoid arthritis in adults with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF; TNF-α) blocking agents. Manufacturer states that use in patients who have not demonstrated an inadequate response to TNF blocking agents is not recommended.

Although efficacy has been demonstrated in clinical studies in patients with prior inadequate response to nonbiologic disease-modifying antirheumatic drugs (DMARDs), manufacturer states that favorable risk-to-benefit ratio has not been established in this population.

Dosage and Administration

General

• To minimize the risk of hypersensitivity reactions and infusion-related events, consider premedication with acetaminophen and diphenhydramine before each infusion. Premedication with methylprednisolone 100 mg IV (or equivalent) is recommended 30 minutes prior to each infusion in patients with rheumatoid arthritis (given in conjunction with antihistamines and acetaminophen in clinical studies). (See Infusion-related Effects under Cautions.)
• Because transient hypotension may occur during administration, it may be appropriate to withhold antihypertensive therapy during the 12-hour period preceding each infusion.
• May be administered in outpatient setting; however, appropriate diagnostic and treatment facilities, including medications for the treatment of severe adverse reactions (e.g., infusion-related reactions, hypersensitivity reactions, cardiac arrhythmias) must be readily available.

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion; do not administer by rapid IV injection (such as IV push or bolus).

Do not admix with other drugs or administer other drugs in the same IV line with rituximab infusion.

Dilution

Must be diluted prior to IV infusion.

Use aseptic technique since drug product contains no preservative.

Withdraw the appropriate dose of rituximab concentrate and dilute in an appropriate volume of 0.9% sodium chloride or 5% dextrose injection to yield a final rituximab concentration of 1–4 mg/mL; gently invert infusion bag several times to ensure complete mixing.

Discard any unused solution remaining in the vial.

Rate of Administration

Infuse initial dose at an initial rate of 50 mg/hour; if hypersensitivity reactions and/or infusion-related events do not occur, infusion rate may be increased in increments of 50 mg/hour every 30 minutes to a maximum infusion rate of 400 mg/hour.

If first infusion is tolerated well, administer subsequent infusions at an initial rate of 100 mg/hour; infusion rate may be increased in increments of 100 mg/hour every 30 minutes as tolerated to a maximum infusion rate of 400 mg/hour.

If first infusion is not tolerated well, administer subsequent infusions at the infusion rates recommended for the initial dose.

Decrease infusion rate or interrupt infusion if hypersensitivity reactions or infusion-related events occur. Employ a slower infusion rate (one-half the previous infusion rate) when therapy is resumed following complete resolution of symptoms.

Dosage

Adults

Non-Hodgkin’s Lymphoma

Relapsed or Refractory Low-grade or Follicular, Antigen CD20-positive, B-cell Non-Hodgkin’s Lymphoma

IV

375 mg/m² administered by IV infusion once weekly for 4 weeks or 8 weeks.

If disease subsequently progresses, administer an additional course of 375 mg/m² once weekly for 4 weeks.

Previously Untreated Follicular, Antigen CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma

IV

375 mg/m² administered by IV infusion on day 1 of each cycle of CVP chemotherapy for up to 8 infusions.

Previously Untreated Low-Grade, Antigen CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma

IV

For patients with stable disease or a partial or complete response following 6–8 cycles of CVP chemotherapy, 375 mg/m² administered by IV infusion once weekly for 4 infusions; repeat every 6 months for up to 16 infusions.

Diffuse Large B-cell, Antigen CD20-positive, Non-Hodgkin’s Lymphoma

IV

375 mg/m² administered by IV infusion on day 1 of each chemotherapy cycle for up to 8 infusions.

Radioimmunotherapy with Rituximab and Ibritumomab

IV

Administer rituximab 250 mg/m² within 4 hours prior to an imaging dose of indium In 111 ibritumomab tiuxetan (coupled with 1 or more whole body scans to assess distribution); 7–9 days later, administer rituximab 250 mg/m² within 4 hours prior to a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan.

Rheumatoid Arthritis

IV

Two doses of 1 g each given by IV infusion 2 weeks apart.

Therapy Interruptions or Discontinuance for Toxicity

Depending on the nature and severity of rituximab-related toxicities, slowing of the infusion rate, interruption of the infusion, or discontinuance of the drug may be required; provide appropriate treatment as indicated. (See Warnings and also General Precautions under Cautions and see Rate of Administration under Dosage and Administration.)

Prescribing Limits

Adults

Non-Hodgkin’s Lymphoma

Relapsed or Refractory Low-grade or Follicular, Antigen CD20-positive, B-cell Non-Hodgkin’s Lymphoma

IV

Safety and efficacy of >2 courses of therapy not established.

Previously Untreated Follicular, Antigen CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma

IV

Maximum 8 infusions.

Previously Untreated Low-Grade, Antigen CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma

IV

Maximum 16 infusions.

Diffuse Large B-cell, Antigen CD20-positive, Non-Hodgkin’s Lymphoma

IV

Maximum 8 cycles of therapy (i.e., 8 rituximab infusions recommended.

Rheumatoid Arthritis

IV

Safety and efficacy of >2 doses (i.e., 1 course of therapy) not established in controlled clinical trials. Limited experience in uncontrolled setting with 2–5 courses (2 doses per course; subsequent courses generally administered 24 weeks, but no sooner than 16 weeks, after previous course).

Special Populations

No special population dosage recommendations at this time.