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.
Published Studies Related to Totect (Dexrazoxane)
Assessment of dexrazoxane as a cardioprotectant in doxorubicin-treated children with high-risk acute lymphoblastic leukaemia: long-term follow-up of a prospective, randomised, multicentre trial. [2010.10]
BACKGROUND: Doxorubicin chemotherapy is associated with cardiomyopathy. Dexrazoxane reduces cardiac damage during treatment with doxorubicin in children with acute lymphoblastic leukaemia (ALL). We aimed to establish the long-term effect of dexrazoxane on the subclinical state of cardiac health in survivors of childhood high-risk ALL 5 years after completion of doxorubicin treatment... INTERPRETATION: Dexrazoxane provides long-term cardioprotection without compromising oncological efficacy in doxorubicin-treated children with high-risk ALL. Dexrazoxane exerts greater long-term cardioprotective effects in girls than in boys. FUNDING: US National Institutes of Health, Children's Cardiomyopathy Foundation, University of Miami Women's Cancer Association, Lance Armstrong Foundation, Roche Diagnostics, Pfizer, and Novartis. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
In vitro and in vivo study on the antioxidant activity of dexrazoxane. [2010.04]
OBJECTIVES: The iron chelator dexrazoxane has been shown to significantly reduce anthracycline-induced cardiac toxicity in several randomized controlled studies. Aim of the present study was to assess the in vitro and in vivo antioxidant effects of dexrazoxane... CONCLUSIONS: Dexrazoxane has in vitro antioxidant capacity. In vivo, it is able to reduce the epirubicin-induced free radical production. The intrinsic antioxidant effect of this compound could explain the reduction of the anthracyclines-induced toxicity in those patients treated with dexrazoxane supplementation. (c) 2009 Elsevier Masson SAS. All rights reserved.
Absence of secondary malignant neoplasms in children with high-risk acute lymphoblastic leukemia treated with dexrazoxane. [2008.03.01]
PURPOSE: Dexrazoxane is a drug used to prevent anthracycline-induced cardiotoxicity. A recent report found an association between the use of dexrazoxane and the risk of developing secondary malignant neoplasms (SMNs) in children with Hodgkin's disease. We report the absence of an association of SMNs in children with acute lymphoblastic leukemia (ALL) treated on Dana-Farber Cancer Institute ALL Consortium Protocol 95-01... CONCLUSION: Dexrazoxane was not associated with an increased risk of SMNs in children treated for HR ALL. Given the potential importance of dexrazoxane as a cardioprotectant, we recommend that dexrazoxane continue to be used and studied in doxorubicin-containing pediatric regimens.
Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. [2007.02.10]
PURPOSE: Pediatric Oncology Group (POG) studies 9426 and 9425 evaluated dexrazoxane (DRZ) as a cardiopulmonary protectant during treatment for Hodgkin's disease (HD). We evaluated incidence and risk factors of acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) and second malignant neoplasms (SMNs)... CONCLUSION: DRZ is a topoisomerase II inhibitor with a mechanism distinct from etoposide and doxorubicin. Adding DRZ to ABVE and ABVE-PC may have increased the incidence of SMN and AML/MDS.
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]
BACKGROUND: Anthracycline-induced cardiotoxicity has led to the adoption of empirical dose limits that may restrict continued use of anthracyclines among patients who might benefit. Dexrazoxane, a cardioprotective agent, has been shown to reduce the risk of anthracycline-associated cardiotoxicity when given from first dose of anthracycline. This study sought to confirm the benefit of dexrazoxane in patients at high risk of cardiotoxicity due to prior anthracycline use... CONCLUSION: Dexrazoxane significantly reduced the occurrence and severity of anthracycline-induced cardiotoxicity in patients at increased risk of cardiac dysfunction due to previous anthracycline treatment without compromising the antitumor efficacy of the chemotherapeutic regimen.
Clinical Trials Related to Totect (Dexrazoxane)
Obatoclax Mesylate, Vincristine Sulfate, Doxorubicin Hydrochloride, and Dexrazoxane Hydrochloride in Treating Young Patients With Relapsed or Refractory Solid Tumors, Lymphoma, or Leukemia [Terminated]
This phase I trial is studying the side effects and best dose of obatoclax mesylate when
given together with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane
hydrochloride in treating young patients with relapsed or refractory solid tumors, lymphoma,
or leukemia. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the
proteins needed for cell growth and causing the cells to self-destruct. Drugs used in
chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane
hydrochloride, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving obatoclax mesylate together with
combination chemotherapy may kill more cancer cells.
Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer [Terminated]
Randomized phase III trial to compare the effectiveness of combination chemotherapy,
surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women
who have stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use
different ways to stop tumor cells from dividing so they stop growing or die.
Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects
of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either
kill them or deliver tumor-killing substances to them without harming normal cells.
Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if
chemotherapy combined with surgery and radiation therapy is more effective with or without
dexrazoxane and trastuzumab in treating breast cancer
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients [Active, not recruiting]
1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and
Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free
survival seen with standard VAC therapy.
2. To evaluate the feasibility and describe the toxicity associated with VACdxr.
3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a
weekly basis for 50- 52 weeks.
4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.
Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in Combination [Active, not recruiting]
This study will primarily address the question whether the combination of Mitoxantrone
therapy with dexrazoxane can reduce cardiotoxic side effects in the treatment of Multiple
Sclerosis patients in comparison to Mitoxantrone monotherapy.
Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer [Terminated]
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop
growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from
the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor
cells and either kill them or deliver tumor-killing substances to them without harming
normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells.
CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity.
There are excellent correlations between the total cumulative dose of doxorubicin, the
severity of the resulting cardiomyopathy, and the level of serum troponin-T.
Page last updated: 2011-12-09