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Rituximab Dosage

Applies to the following strength(s): 10 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for non-Hodgkin's Lymphoma

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine.

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 NON-HODGKIN'S 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:
-Initiate 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.

RECOMMENDED DOSE FOR NON-HODGKIN'S LYMPHOMA (NHL):
Recommended dose: 375 mg/m2 IV according to the following schedules:
-Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell 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
-Diffuse Large B-Cell NHL: 375 mg/m2 on Day 1 of each cycle of chemotherapy for up to 8 infusions

RECOMMENDED DOSE AS A COMPONENT OF IBRITUMOMAB TIUXETAN THERAPY FOR TREATMENT OF NHL:
-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.
-Refer to the ibritumomab tiuxetan package insert for full prescribing information regarding the ibritumomab tiuxetan therapeutic regimen.

Use: Non-Hodgkin's Lymphoma (NHL):
-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 this drug 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

Usual Adult Dose for Rheumatoid Arthritis

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. 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.

-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.

RECOMMENDED DOSE FOR RHEUMATOID ARTHRITIS (RA):
-This drug is given in combination with methotrexate
-Administer rituximab 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

Use: Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies

Usual Adult Dose for Chronic Lymphocytic Leukemia

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. 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.

RECOMMENDED DOSE FOR CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): 375 mg/m2 IV the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 through 6 (every 28 days)

Use: This drug is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL

Usual Adult Dose for Wegener's Granulomatosus

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. Pneumocystis jiroveci pneumonia (PCP) is recommended for patients with GPA and MPA during treatment and for at least 6 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.

RECOMMENDED DOSE FOR GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER'S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA):
-Administer rituximab as a 375 mg/m2 intravenous infusion once weekly for 4 weeks
-Glucocorticoids administered as methylprednisolone 1000 mg IV 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 rituximab and may continue during and after the 4 week course of rituximab treatment.
-Safety and efficacy of treatment with subsequent courses of this drug have not been established

Use: This drug, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

Usual Adult Dose for Microscopic Polyangiitis

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. Pneumocystis jiroveci pneumonia (PCP) is recommended for patients with GPA and MPA during treatment and for at least 6 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.

RECOMMENDED DOSE FOR GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER'S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA):
-Administer rituximab as a 375 mg/m2 intravenous infusion once weekly for 4 weeks
-Glucocorticoids administered as methylprednisolone 1000 mg IV 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 rituximab and may continue during and after the 4 week course of rituximab treatment.
-Safety and efficacy of treatment with subsequent courses of this drug have not been established

Use: This drug, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY:
-INFUSION REACTIONS: This drug can cause serious, including fatal infusion reactions. Deaths within 24 hours of infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Patients should be monitored closely. Discontinue the infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions.
-SEVERE MUCOCUTANEOUS REACTIONS: Severe, including fatal, mucocutaneous reactions can occur in patients receiving this drug.
-HEPATITIS B VIRUS (HBV) REACTIVATION: HBV reactivation can occur in patients treated with this drug, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with this drug. Discontinue this drug and concomitant medications in the event of HBV reactivation.
-PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): PML, including fatal cases, can occur in patients receiving this drug.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Do not administer as an intravenous push or bolus. Administer only as an IV infusion.

General:
-Extreme caution and careful monitoring are recommended in patients who have a high number of circulating malignant cells (greater than 25 x 10(9)/L). These patients may have an increased risk of severe infusion-related reactions, which can have a fatal outcome. This is particularly applicable to patients with a high tumor burden, such as chronic lymphocytic leukemia or mantle cell lymphoma. A reduced infusion rate should be considered for the first infusion in these patients.
-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.
-Since transient hypotension may occur during the infusion, consideration should be given to withholding antihypertensive medications 12 hours prior to the infusion.

Storage requirements:
-Consult the manufacturer product information.

Reconstitution/preparation techniques:
-Consult the manufacturer product information.

IV compatibility:
-Consult the manufacturer product information.

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

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