DOSAGE AND ADMINISTRATION
Vial contents must be mixed and diluted before use.
Dose:
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 recommended dose is: | | maximum recommended dose: |
| Day one: | 1000 mg/m2 | 2000 mg |
| Day two: | 1000 mg/m2 | 2000 mg |
| Day three: | 500 mg/m2 | 1000 mg |
The Totect™ dose should be reduced by 50% in patients with creatinine clearance values <40 mL/min.
Preparation and administration:
The indicated dose should be administered as an intravenous infusion over 1 to 2 hours 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 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.
Directions for Mixing and Diluting:
Read this entire section carefully before mixing and diluting.
Aseptic technique should be used during preparation.
Totect™ should not be mixed or administered with any other drug during infusion.
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.
Totect™ is provided in a carton containing 10 vials of Totect™ (dexrazoxane for injection) and 10 vials of diluent, to provide 3 days of treatment for 1 patient.
Before infusion, each vial of dexrazoxane (contains 589 mg dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane) must be mixed with 50 mL of diluent. The mixed solution should be further diluted in 1000 mL 0.9% NaCl.
Preparation of the Totect™ mixed and diluted solution.
- Each vial of Totect™ (dexrazoxane for injection ) (500 mg) must be mixed with 50 mL of diluent.
- The solution should be used immediately (within 2 hours) after preparation. It contains no antibacterial preservative.
- Inject the mixed volume into the infusion bag with 1000 mL 0.9% NaCl. Totect™ must not be mixed with any other drugs.
- Repeat steps 1 and 2. in order to obtain the required dose, and inject all the required mixed solutions into the same 1000 mL 0.9% NaCl bag.
- Totect™ should be infused over 1 to 2 hours at room temperature and normal light conditions.
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.
The reconstituted product should be used immediately after mixing and diluting as it contains no antibacterial preservative. The product is stable for 4 hours from the time of mixing and diluting when stored below 25°C (77°F).
Instructions for handling and disposal
Caution must be exercised when handling TotectTM, preparing the mixed solution and disposing of the product. Procedures for proper handling of cytotoxic drugs should be adopted, as outlined in the references1-5. Direct contact of TotectTM with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water.
|
