Totect (Dexrazoxane Hydrochloride) - Summary

TOTECT SUMMARY

Totect™ Package Insert

Totect™ (dexrazoxane for injection) is a sterile, pyrogen-free lyophilizate intended for intravenous (IV) administration. Totect™ is provided in a carton consisting of 10 vials of Totect™ and 10 vials of diluent.

Totect™ is indicated for the treatment of extravasation resulting from IV anthracycline chemotherapy.

TOTECT NEWS HIGHLIGHTS

Published Studies Related to Totect (Dexrazoxane)

Absence of secondary malignant neoplasms in children with high-risk acute lymphoblastic leukemia treated with dexrazoxane. [2008.03.01]

Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. [2007.02.10]

Multicenter randomized phase III study of the cardioprotective effect of dexrazoxane (Cardioxane) in advanced/metastatic breast cancer patients treated with anthracycline-based chemotherapy. [2006.04]

Effect of epirubicin-based chemotherapy and dexrazoxane supplementation on QT dispersion in non-Hodgkin lymphoma patients. [2005.12]

The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. [2004.07.08]

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Clinical Trials Related to Totect (Dexrazoxane)

Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer [Completed]

Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients [Recruiting]

Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone Sarcoma [Active, not recruiting]

Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma [Completed]

Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease [Completed]

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