Generic name: DEXRAZOXANE HYDROCHLORIDE 500mg
Dosage form: injection, powder, lyophilized, for solution
Medically reviewed on February 8, 2018.
Vial contents and diluted with 50 mL of 0.167 M sodium lactate injection solution before use [see Dosage and Administration (2.3)].
Administer Totect once daily for 3 consecutive days. Initiate the first infusion as soon as possible and within the first six hours after extravasation [see Dosage and Administration (2.4)].
The individual dosage is based on calculation of the Body Surface Area (BSA) up to a maximum dose of 2000 mg (each on Day 1 and 2) and 1000 mg (Day 3), corresponding to a BSA of 2 m2.
|The recommended dose is:||Maximum daily dose:|
|Day one: 1000 mg/m2||2000 mg|
|Day two: 1000 mg/m2||2000 mg|
|Day three: 500 mg/m2||1000 mg|
Reduce the Totect dose by 50% in patients with creatinine clearance values < 40 mL/min.
Directions for Mixing and Final Dilution
Read this entire section carefully before mixing and diluting.
Aseptic technique should be used during preparation.
Use caution when handling and preparing the reconstituted solution. The use of gloves is recommended. If Totect powder or solutions contact the skin or mucosae, wash exposed area immediately and thoroughly with soap and water. Follow special handling and disposal procedures.1
Totect should not be mixed or administered with any other drug during the infusion.
Preparation of Totect
Step 1. Each vial of Totect (dexrazoxane for injection) (500 mg) must first be mixed with 50 mL of 0.167M sodium lactate injection solution.
Dilution of sodium lactate injection to 0.167M is required before using it to reconstitute Totect. Add 1.67 mL of 5 mEq/mL sodium lactate injection to 50 mL sterile water for injection to make 50 mL of 0.167M sodium lactate injection solution.
After reconstitution of Totect with 50 mL of 0.167M sodium lactate injection solution, the resultant Totect solution contains 10 mg/mL. This resultant solution should be further diluted within 2 hours. It contains no antibacterial preservative.
Step 2. Withdraw the recommended dose from the Totect solution containing 10 mg/mL as prepared in Step 1 and further dilute into an infusion bag containing 1000 mL 0.9% Sodium Chloride. In order to obtain the required dose, more than one vial may be needed. Totect must not be mixed with any other drugs.
The infusion bag should be used immediately after preparation. The product is stable for 4 hours from the time of preparation when stored below 25ºC (77ºF).
The solution of Totect is slightly yellow.
Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Solutions containing a precipitate should be discarded. Vials are for single use only. Unused solution should be discarded.
Do not administer or mix Totect with any other drug during the infusion.
Remove cooling procedures such as ice packs, if used, from the extravasation area at least 15 minutes before Totect administration in order to allow sufficient blood flow to the area of extravasation.
Administer as an intravenous infusion over 1 to 2 hours at room temperature and normal light conditions in a large caliber vein in an extremity/area other than the one affected by the extravasation.
Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day.
Perform local examination for extravasation on a regular basis after treatment and until resolution.
If vesicant compounds other than anthracyclines are being used through the same IV access, (e.g. vincristine, mitomycin, and vinorelbine), consider treatments for these other vesicant compounds. Totect is not effective against the effects of vesicants other than anthracyclines [see Clinical Studies (14)].
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: miscellaneous uncategorized agents
Other brands: Zinecard