Generic name: rituximab 10mg in 1mL
Dosage form: injection, solution
Medically reviewed on February 4, 2019.
Important Dosing Information
Administer only as an Intravenous Infusion [see Dosage and Administration (2.8)].
Do not administer as an intravenous push or bolus. RITUXAN should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur [see Warnings and Precautions (5.1)].
Premedicate before each infusion [see Dosage and Administration (2.8)].
Prior to First Infusion: Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RITUXAN [see Warnings and Precautions (5.3)]. Obtain complete blood counts including platelets (CBC) prior to the first dose.
During RITUXAN Therapy: In patients with lymphoid malignancies, during treatment with RITUXAN monotherapy, obtain complete blood counts (CBC) with differential and platelet counts prior to each RITUXAN course. During treatment with RITUXAN and chemotherapy, obtain CBC with differential and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias [see Adverse Reactions (6.1)]. In patients with RA, GPA or MPA, obtain CBC with differential and platelet counts at two to four month intervals during RITUXAN therapy. Continue to monitor for cytopenias after final dose and until resolution.
- 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).
- Interrupt the infusion or slow the infusion rate for infusion-related reactions [see Boxed Warning, Warnings and Precautions (5.1)]. 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, B-Cell NHL
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 a rituximab product 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® for treatment of NHL
- 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-related 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)
Induction Treatment of Patients with Active GPA/MPA
- Administer RITUXAN as a 375 mg/m2 intravenous infusion once weekly for 4 weeks for patients with active GPA or MPA.
- 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 induction course of RITUXAN treatment.
Follow up Treatment of Patients with GPA/MPA who have achieved disease control with induction treatment
- Administer RITUXAN as two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation.
- Patients should receive 100 mg intravenous methylprednisolone to be completed 30 minutes prior to each RITUXAN infusion.
- If induction treatment of active disease was with RITUXAN, follow up treatment with RITUXAN should be initiated within 24 weeks after the last RITUXAN induction infusion or based on clinical evaluation, but no sooner than 16 weeks after the last RITUXAN induction infusion.
- If induction treatment of active disease was with other standard of care immunosuppressants, RITUXAN follow up treatment should be initiated within the 4 week period that follows achievement of disease control.
Recommended Dose for Pemphigus Vulgaris (PV)
- Administer RITUXAN as two-1000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids.
- Maintenance treatment
Administer RITUXAN as a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation.
- Treatment of relapse
Administer RITUXAN as a 1000 mg intravenous infusion on relapse, and consider resuming or increasing the glucocorticoid dose based on clinical evaluation.
Subsequent infusions of RITUXAN may be administered no sooner than 16 weeks following the previous infusion.
Recommended Dose for Premedication and Prophylactic Medications
Premedicate with acetaminophen and an antihistamine before each infusion of RITUXAN. 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 (14.4)].
For RA and PV 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 [see Dosage and Administration (2.6)].
Provide prophylaxis treatment for Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections for patients with CLL during treatment and for up to 12 months following treatment as appropriate [see Warnings and Precautions (5.6)].
PCP prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last RITUXAN infusion.
PCP prophylaxis should be considered for patients with PV during and following RITUXAN treatment.
Administration and Storage
Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. RITUXAN should be a clear, colorless liquid. Do not use vial if particulates or discoloration is present.
Withdraw the necessary amount of RITUXAN and dilute to a final concentration of 1 mg/mL to 4 mg/mL in an infusion bag containing either 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, 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.
Diluted RITUXAN solutions for infusion may be stored at 2°C to 8°C (36°F to 46°F) for 24 hours. Diluted 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 to 8°C). No incompatibilities between RITUXAN and polyvinylchloride or polyethylene bags have been observed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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