Drug Information for Totect Kit (dexrazoxane) for injection, for intravenous infusion onlyInitial U.S. Approval: 2007 (TopoTarget USA): 2 DOSAGE AND ADMINISTRATION

Vial contents must be mixed and diluted before use.

Totect^® should be given once daily for 3 consecutive days. The first infusion should be initiated as soon as possible and within the first six hours after extravasation.

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 Totect^® dose should be reduced by 50% in patients with creatinine clearance values < 40 mL/min.

Read this entire section carefully before mixing and diluting.

Aseptic technique should be used during preparation.

Caution must be exercised when handling Totect^® and preparing the mixed solution. [see How Supplied/Storage and Handling (16)]

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 the enclosed diluent. The resultant solution contains 10 mg/mL. This resultant solution should be used immediately (within 2 hours) after preparation. It contains no antibacterial preservative.

Step 2. Withdraw the recommended dose from the 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.

Totect^® should not be mixed or administered with any other drug during the infusion. 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. Cooling procedures such as ice packs, if used, should be removed from the extravasation area at least 15 minutes before Totect^® administration in order to allow sufficient blood flow to the area of extravasation. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day.