Rituximab Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for non-Hodgkin's Lymphoma

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

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: 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 Non-Hodgkins Lymphoma (NHL) and Diffuse Large B-cell NHL (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. Begin the infusion at a rate of 20% of the total dose given in the first 30 minutes and administer the remaining 80% of the total dose over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used for subsequent cycles. Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count greater than or equal to 5000/mm3 before Cycle 2 should not be given the 90-minute infusion.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's Lymphoma (NHL): 375 mg/m2 IV once weekly for 4 or 8 doses.

Retreatment for Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell NHL: 375 mg/m2 IV once weekly for 4 doses.

Previously untreated, follicular, CD20-positive, B-cell NHL: 375 mg/m2 IV, administered on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate rituximab maintenance 8 weeks following completion of rituximab in combination with chemotherapy. Administer rituximab 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 to 8 cycles of CVP chemotherapy, administer 375 mg/m2 IV once weekly for 4 doses at 6 month intervals to a maximum of 16 doses.

DLBCL: 375 mg/m2 IV given on day 1 of each cycle of chemotherapy for up to 8 doses.

Chronic Lymphocytic Leukemia (CLL): 375 mg/m2 the day prior to initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 through 6 (every 28 days).

As a required component of ibritumomab tiuxetan therapeutic regimen: rituximab 250 mg/m2 should be infused within 4 hours prior to the administration of Indium-111- (In-111-) ibritumomab tiuxetan and within 4 hours prior to the administration of Yttrium-90- (Y-90-) ibritumomab tiuxetan. Administration of rituximab and In-111-ibritumomab tiuxetan should precede rituximab and Y-90-ibritumomab tiuxetan by 7 to 9 days. (Note: The ibritumomab tiuxetan therapeutic regimen is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular non-Hodgkin's lymphoma.)

Usual Adult Dose for Rheumatoid Arthritis

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

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: 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.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Rheumatoid Arthritis: Rituximab is given in combination with methotrexate. Rituximab 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. Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.

Usual Adult Dose for Chronic Lymphocytic Leukemia

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

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: 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.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Chronic Lymphocytic Leukemia (CLL): 375 mg/m2 IV the day prior to the initiation of fludarabine and cyclophosphamide (FC) chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 to 6 (every 28 days).

Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

Usual Adult Dose for Wegener's Granulomatosus

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

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: 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.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA): 375 mg/m2 IV administered once weekly for 4 weeks.

Glucocorticoids administered as methylprednisolone 1000 mg IV daily 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 rituximab and may continue during and after the 4 week course of rituximab treatment.

Safety and efficacy of treatment with subsequent courses of rituximab have not been established.

PCP prophylaxis is recommended for patients with WG and MPA during treatment and for at least 6 months following the last rituximab infusion.

Usual Adult Dose for Microscopic Polyangiitis

Information for all healthcare professionals administering rituximab: Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

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: 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.

Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA): 375 mg/m2 IV administered once weekly for 4 weeks.

Glucocorticoids administered as methylprednisolone 1000 mg IV daily 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 rituximab and may continue during and after the 4 week course of rituximab treatment.

Safety and efficacy of treatment with subsequent courses of rituximab have not been established.

PCP prophylaxis is recommended for patients with WG and MPA during treatment and for at least 6 months following the last rituximab infusion.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Do not administer as IV push or bolus.

Premedication consisting of acetaminophen and diphenhydramine should be considered before each infusion of rituximab.

Since transient hypotension may occur during rituximab infusion, consideration should be given to withholding antihypertensive medications 12 hours prior to rituximab infusion.

The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. 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. The infusion can continue at one-half the previous rate upon improvement of patient symptoms. If the patient tolerated the first infusion well, subsequent rituximab 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.

Because rituximab targets all CD20-positive B lymphocytes, malignant and nonmalignant, complete blood counts (CBC) and platelet counts should be obtained at regular intervals during rituximab therapy and more frequently in patients who develop cytopenias. The duration of cytopenias caused by rituximab can extend well beyond the treatment period.

There have been no formal drug interaction studies performed with rituximab. However, renal toxicity was seen with this drug in combination with cisplatin in clinical trials.

The safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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