Rituximab is available as a preservative-free 10-mg/mL concentrate solution in 100- and 500-mg single-use vials.3083 Each mL also contains polysorbate 80 0.7 mg, sodium chloride 9 mg, sodium citrate dihydrate 7.35 mg, and water for injection.3083
Before preparing a solution for intravenous infusion, rituximab vials should be visually inspected for particulate matter or discoloration; vials should not be used if particulates or discoloration is present.3083 The appropriate dose of rituximab should be withdrawn and diluted in an infusion bag containing sodium chloride 0.9% or dextrose 5% to yield a final concentration of 1 to 4 mg/mL.3083 The bag should be gently inverted to mix the solution.3083 Any unused portion remaining in the vial should be discarded.3083
pH
6.5.3083
Osmolality
Rituximab is nearly isotonic with an osmolality of approximately 360 mOsm/kg.3085
Trade Name(s)
Rituxan, MabThera
Rituximab is administered only by intravenous infusion after dilution in dextrose 5% or sodium chloride 0.9%.3083 The drug should not be administered by intravenous push or bolus injection.3083 Patients should receive appropriate premedications as indicated.3083
The first infusion should be initiated at a rate of 50 mg/hr.3083 In the absence of infusion toxicity, the rate may be increased every 30 minutes in increments of 50 mg/hr to a maximum rate of 400 mg/hr.3083 Subsequent standard infusions may be initiated at 100 mg/hr and, in the absence of infusion toxicity, the rate may be increased every 30 minutes in increments of 100 mg/hr to a maximum rate of 400 mg/hr.3083 Certain patients treated for specific indications may be eligible for a 90-minute subsequent infusion (i.e., 20% of the dose administered over 30 minutes followed by the remaining 80% administered over 60 minutes); specific product labeling should be consulted for additional administration details.3083
Rituximab concentrate is a clear, colorless solution.3083 Intact vials are stable at 2 to 8°C.3083 Vials should be protected from direct sunlight and should not be frozen or shaken.3083
Rituximab solutions diluted for infusion may be stored for 24 hours at 2 to 8°C.3083 Diluted solutions have demonstrated stability for an additional 24 hours at room temperature; however, since such solutions do not contain a preservative, the manufacturer recommends that diluted solutions be stored under refrigeration at 2 to 8°C.3083
Sorption
No incompatibilities have been observed with rituximab and bags composed of polyvinyl chloride (PVC) or polyethylene.3083 The manufacturer states that the use of containers other than those made of PVC or polyethylene (e.g., evacuated glass bottles) with rituximab has not been evaluated and is therefore not recommended.3085
Filtration
Use of an inline filter is not required for administration of rituximab-containing solutions.3085 Based on the results of a study evaluating the effects of using a 0.2-µm inline filter to administer various concentrations of diluted rituximab, inadvertent use of an inline filter is not expected to be problematic.3085
For a list of references cited in the text of this monograph, search the monograph titled References.