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Each TOTECT carton contains 1 single dose vial of TOTECT (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder.
NDC 66220-110-01: Carton of 1 vial of TOTECT
Store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use. Follow special handling and disposal procedures [see Dosage and Administration].1
INDICATION: TOTECT® (dexrazoxane) is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Vial contents must be mixed and diluted with 50 mL of 0.167 M sodium lactate injection solution 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.
Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman. Apprise women of potential harm to the fetus.
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 (≥16%) are nausea, fever, injection site pain and vomiting.
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