Administer TOTECT within 6 hours of the extravasation.
It must be re-administered as follows:
Second dose, day 2: 24 (±3) hours after day 1
Third dose, day 3: 48 (±3) hours after day 1
|Calculate the dose required. In order to obtain the required dose, more than one vial may be needed.|
|Each vial of TOTECT (500 mg) must first be mixed with 50 mL of sodium lactate injection solution (0.167 M). To create this sodium lactate injection solution, add 1.67 mL of 5 mEq/mL sodium lactate injection to 50 mL sterile water for injection. After reconstitution, the resultant TOTECT solution contains 10 mg/mL.|
|Withdraw the recommended dose from the solution containing 10 mg/mL as prepared in Step 2 and further dilute into an infusion bag containing 1000 mL 0.9% Sodium Chloride. The solution of TOTECT is slightly yellow. The product is stable for 4 hours from the time of preparation when stored below 25ºC (77ºF).|
|Remove any local cooling at least 15 minutes prior to administration.|
|Administer TOTECT as an intravenous infusion over 1-2 hours. Infusion should be in a large vein of an extremity or area other than the one affected by the extravasation, as soon as possible within the first 6 hours after the incident. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day.|
As TOTECT is a hazardous drug, follow all hazardous drug safety precautions.
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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