n Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1500/µL) and the platelet count exceeds 100 × 109/L (100,000/µL). The next cycle of TEMODAR should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst non-hematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 2 and 3 in the Full Prescribing Information under 2.1 Recommended Dosing and Dose Modification Guidelines.
How is TEMODAR for Injection prepared? [See Full Prescribing Information, Preparation and Administration, TEMODAR for Injection (2.2)].
Care should be exercised in the handling and preparation of TEMODAR. Vials should not be opened. If vials are accidentally opened or damaged, rigorous precautions should be taken with the contents to avoid inhalation or contact with the skin or mucous membranes. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial. Procedures for proper handling and disposal of anticancer drugs should be considered1–4. Several guidelines on this subject have been published.
TEMODAR for Injection vials should be stored refrigerated at 2°–8°C (36°–46°F).
Bring the vial to room temperature prior to reconstitution with Sterile Water for Injection.
Using aseptic technique, reconstitute each vial with 41 mL Sterile Water for Injection. The resulting solution will contain 2.5 mg/mL temozolomide.
Vial should be gently swirled and not shaken. Inspect vials, and any vial containing visible particulate matter should not be used. Do not further dilute the reconstituted solution. Upon reconstitution, store at room temperature for up to 14 hours, including infusion time.
Using aseptic technique, withdraw up to 40 mL from each vial to make up the total dose and transfer into an empty 250 mL PVC infusion bag. Studies with non-PVC bags have not been conducted.
Attach the pump tubing to the bag, purge the tubing and then cap.
How is TEMODAR for Injection administered? [See Full Prescribing Information, Preparation and Administration, TEMODAR for Injection (2.2)].
TEMODAR for Injection is administered as an intravenous infusion over 90 minutes. Bioequivalence has been established only when TEMODAR for Injection was given over 90 minutes. TEMODAR for Injection should be administered only by intravenous infusion. Flush the lines before and after each TEMODAR infusion.
Because no data are available on the compatibility of TEMODAR for Injection with other intravenous substances or additives, other medications should not be infused simultaneously through the same intravenous line.
What should the patient avoid during treatment with TEMODAR? [See Full Prescribing Information, Use in Specific Populations, Pregnancy (8.1) and Nursing Mothers (8.3)].
There are no dietary restrictions for patients taking TEMODAR. TEMODAR may affect testicular function, so male patients should exercise adequate birth control measures. TEMODAR may cause birth defects. Female patients should avoid becoming pregnant while receiving this drug. It is not known whether TEMODAR is excreted into breast milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing in |
