How to use Rituxiver:
Administer only as an Intravenous Infusion. Do not administer as an intravenous push or bolus. RITUXIVER 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.
Premedicate before each infusion.
Prior to First Infusion: Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RITUXIVER. Obtain complete blood counts (CBC) including platelets prior to the first dose.
During RITUXIVER Therapy: In patients with lymphoid malignancies, during treatment with RITUXIVER monotherapy, obtain complete blood counts (CBC) with differential and platelet counts prior to each RITUXIVER course. During treatment with RITUXIVER and chemotherapy, obtain CBC with differential and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias. In patients with RA, GPA or MPA, obtain CBC with differential and platelet counts at two to four month intervals during RITUXIVER 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).
Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count ≥5,000/mm3 before Cycle 2 should not be administered the 90-minute infusion.
- Interrupt the infusion or slow the infusion rate for infusion-related reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.
Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. RITUXIVER should be a clear, colorless liquid. Do not use vial if particulates or discoloration is present.
Use a sterile needle and syringe to prepare RITUXIVER. Withdraw the necessary amount of RITUXIVER 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 RITUXIVER solutions for infusion may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for 24 hours. Diluted RITUXIVER solutions for infusion have been shown to be stable for an additional 24 hours at room temperature. However, since RITUXIVER solutions do not contain a preservative, diluted solutions should be stored refrigerated (2°C to 8°C). No incompatibilities between RITUXIVER and polyvinylchloride or polyethylene bags have been observed.