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Totect Dosage

Generic name: DEXRAZOXANE HYDROCHLORIDE 500mg
Dosage form: injection, powder, lyophilized, for solution

Medically reviewed by Drugs.com. Last updated on Nov 21, 2018.

Recommended Dose

Reconstitute and further dilute Totect 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

Dose Modifications

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.

The prepared 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.

Totect solution can be prepared with EITHER Sterile Water for Injection, USP and Lactated Ringer’s Injection OR 0.167M sodium lactate injection and 0.9% Sodium Chloride Injection– refer carefully to the instructions below.

Preparation of Totect Solution using Sterile Water for Injection, USP and Lactated Ringer’s Injection, USP

Step 1. Reconstitute each Totect vial with 50 mL of Sterile Water for Injection, USP. Once reconstituted, the reconstituted Totect solution contains 10 mg/mL of Totect.

Step 2. Calculate the volume of the 10 mg/mL reconstituted Totect solution needed for the recommended dose. In order to obtain the required dose, more than one vial may be needed. The reconstituted solution should be further diluted within 30 minutes after initial reconstitution. It contains no antibacterial preservative.

Step 3. Withdraw the calculated volume from the reconstituted Totect solution and further dilute into an infusion bag containing 1000 mL of Lactated Ringer’s Injection. Do not mix Totect with any other drugs.

Use the Totect infusion bag immediately after preparation. If not used immediately, the product is stable for 4 hours from the time of preparation when stored at room temperature or for up to 12 hours when stored refrigerated between 2-8ºC (36-46°F).

Preparation of Totect Solution using 0.167M Sodium Lactate Injection and 0.9% Sodium Chloride Injection

Step 1. Reconstitute each Totect vial with 50 mL of 0.167M sodium lactate injection solution.

Preparation 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, USP to make 50 mL of 0.167M sodium lactate injection solution.

Once reconstituted, the reconstituted Totect solution contains 10 mg/mL of Totect.

Step 2. Calculate the volume of the 10 mg/mL reconstituted Totect solution needed for the recommended dose. In order to obtain the required dose, more than one vial may be needed. The reconstituted solution should be further diluted within 30 minutes after initial reconstitution. It contains no antibacterial preservative.

Step 3. Withdraw the calculated volume from the reconstituted Totect solution and further dilute into an infusion bag containing 1000 mL of 0.9% Sodium Chloride Injection. Do not mix Totect with any other drugs.

Use the Totect infusion bag immediately after preparation. If not used immediately, the product is stable for 4 hours from the time of preparation when stored at room temperature or for up to 12 hours when stored refrigerated between 2-8ºC (36-46°F).

Administration

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)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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