Each TOTECT® carton contains 1 single dose vial of TOTECT (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder.
Vial contents must be mixed and diluted with 50 mL of 0.167 M sodium lactate injection solution before use.
TOTECT should be given once daily for 3 consecutive days. Initiate the first infusion 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.
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.
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.
INDICATION: TOTECT® (dexrazoxane) is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Vial contents must be reconstituted and diluted with 50 mL of 0.167 M sodium lactate injection solution and further mixed and diluted with the recommended dose in 1000 mL 0.9% Sodium Chloride before use. The TOTECT dose should be reduced by 50% in patients with creatinine clearance values < 40 mL/min.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Myelosuppression: TOTECT is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring during treatment with TOTECT and cytotoxic chemotherapy as the myelosuppression and cytotoxic potential may be additive to that of chemotherapy alone.
Anaphylactic/Hypersensitivity Reactions: Hypersensitivity reactions including anaphylactic reaction, angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have occurred in patients treated with dexrazoxane products and anthracyclines. Previous history of allergy to dexrazoxane products should be carefully considered prior to administration. Consider permanent discontinuation in patients with severe hypersensitivity reactions.
Embryo-Fetal Toxicity: TOTECT can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk and to use effective contraception during treatment and 6 months following the last dose of TOTECT. Use in patients with hepatic impairment is not recommended.
TOTECT is not recommended for use with dimethyl sulfoxide (DMSO).
In the clinical studies, TOTECT was administered to patients also receiving chemotherapeutic agents for cancer, and the adverse reaction profile reflects the combination of TOTECT, underlying disease, and already administered chemotherapy. The most common adverse reactions (≥15%) are nausea, fever, injection site pain, vomiting, and postoperative infection.
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