Temozolomide is available as a lyophilized powder in single-use vials containing 100 mg of the drug.3145 Each vial also contains mannitol 600 mg, L-threonine 160 mg, polysorbate 80 120 mg, sodium citrate dihydrate 235 mg, and hydrochloric acid 160 mg.3145
Vials containing temozolomide should be allowed to reach room temperature prior to reconstitution.3145 Each 100-mg vial of temozolomide should be reconstituted with 41 mL of sterile water for injection to yield a solution with a final temozolomide concentration of 2.5 mg/mL.3145 Vials should be gently swirled until the contents are dissolved; vials should not be shaken.3145 The reconstituted solution should be visually inspected; if particulate matter is visible, the solution should not be used.3145 Up to 40 mL may be withdrawn from each reconstituted vial and transferred to an empty 250-mL infusion bag to make up the total dose.3145 The reconstituted solution should not be further diluted.3145
Trade Name(s)
Temodar
Temozolomide is administered only by intravenous infusion over 90 minutes using an infusion pump.3145 Infusion over a period of time other than 90 minutes may result in suboptimal dosing.3145
Temozolomide should be infused through a separate line, or, if a common infusion line is being used to administer other drugs, the line should be flushed (e.g., with sodium chloride 0.9%) prior to and following infusion of temozolomide.3145
As with other toxic drugs, temozolomide should be prepared and administered with care.3145 Vials of the drug should not be opened.3145 Protective measures (e.g., the use of gloves and eye protection) should be taken to avoid inadvertent contact with or inhalation of the drug in the case of breakage of the vial or other accidental spillage.3145 Applicable disposal procedures for the drug should be followed.3145
Temozolomide is a white to light tan or light pink powder.3145 Intact vials of temozolomide should be stored at 2 to 8°C.3145
The reconstituted solution should be stored at room temperature (i.e., 25°C).3145 The total time from reconstitution through completion of administration should not exceed 14 hours.3145
pH Effects
Temozolomide is stable at acidic pH (less than 5) and is alkali labile.3145
Additional Compatibility Information
Infusion Solutions
The manufacturer states that temozolomide solution may be administered in the same intravenous infusion line only with sodium chloride 0.9%.3145
For a list of references cited in the text of this monograph, search the monograph titled References.