Overview
An antimitotic agent with immunosuppressive properties. Dexrazoxane, the (+)-enantiomorph of razoxane, provides cardioprotection against anthracycline toxicity. It appears to inhibit formation of a toxic iron-anthracycline complex. [PubChem] The Food and Drug Administration has designated dexrazoxane as an orphan drug for use in the prevention or reduction in the incidence and severity of anthracycline-induced cardiomyopathy.
Indication
For reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m^2 and would benefit from continued doxorubicin therapy. Also approved for the treatment of extravasation from intravenous anthracyclines.
Associated Conditions
- Doxorubicin Induced Cardiomyopathy
- Drug Extravasation
Research Report
Dexrazoxane (DB00380): A Comprehensive Monograph on its Cardioprotective and Chemoprotective Roles in Oncology
Section 1: Introduction to Dexrazoxane
Executive Summary
Dexrazoxane (DrugBank ID: DB00380) is a unique, systemically administered cytoprotective agent belonging to the bisdioxopiperazine class of compounds.[1] It occupies a distinct niche in modern oncology, primarily defined by its dual, yet highly specific, roles in mitigating the toxicities of anthracycline chemotherapy. First, it serves as a cardioprotective agent, administered to reduce the incidence and severity of cumulative, dose-dependent cardiomyopathy, a major source of long-term morbidity and mortality in cancer survivors treated with drugs like doxorubicin.[4] Second, it functions as a targeted chemoprotective agent, acting as the only approved antidote for the treatment of severe local tissue damage (extravasation) that can occur when intravenous anthracyclines leak from the vein into surrounding tissues.[7] Marketed under brand names including Zinecard®, Totect®, and Cardioxane®, Dexrazoxane addresses critical unmet needs that arise directly from the use of one of the most effective and widely used classes of anticancer drugs.[4]
The Central Clinical Problem
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/10/18 | Phase 3 | Recruiting | |||
2024/02/16 | Phase 2 | Recruiting | Princess Maxima Center for Pediatric Oncology | ||
2024/01/23 | Phase 3 | Recruiting | Stichting Hemato-Oncologie voor Volwassenen Nederland | ||
2023/05/15 | Phase 1 | Completed | |||
2022/03/23 | Phase 1 | Active, not recruiting | Andrew E. Place, MD | ||
2021/08/09 | Phase 1 | UNKNOWN | |||
2020/03/03 | Phase 3 | Recruiting | |||
2019/04/29 | Phase 1 | Completed | |||
2018/12/26 | Phase 2 | Active, not recruiting | |||
2018/10/05 | Phase 2 | Terminated | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Almaject, Inc. | 72611-716 | INTRAVENOUS | 500 mg in 50 mL | 12/1/2016 | |
Gland Pharma Limited | 68083-388 | INTRAVENOUS | 250 mg in 25 mL | 6/23/2025 | |
Fosun Pharma USA Inc. | 72266-101 | INTRAVENOUS | 500 mg in 50 mL | 6/13/2022 | |
Hikma Pharmaceuticals USA Inc. | 0143-9248 | INTRAVENOUS | 10 mg in 1 mL | 12/13/2018 | |
Breckenridge Pharmaceutical, Inc. | 51991-942 | INTRAVENOUS | 500 mg in 50 mL | 2/10/2021 | |
Gland Pharma Limited | 68083-195 | INTRAVENOUS | 500 mg in 50 mL | 6/23/2025 | |
Novadoz Pharmaceuticals LLC | 72205-247 | INTRAVENOUS | 250 mg in 25 mL | 4/9/2025 | |
Almaject, Inc. | 72611-716 | INTRAVENOUS | 500 mg in 50 mL | 12/1/2016 | |
Fosun Pharma USA Inc. | 72266-235 | INTRAVENOUS | 250 mg in 25 mL | 6/13/2022 | |
Clinigen Healthcare Ltd | 76310-002 | INTRAVENOUS | 500 mg in 1 1 | 7/14/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/27/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
DEXRAZOXANE-REACH dexrazoxane 250 mg powder for injection for infusion vial | 428033 | Medicine | A | 3/24/2025 | |
DEXRAZOXANE-REACH dexrazoxane 500 mg powder for injection for infusion vial | 428034 | Medicine | A | 3/24/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
DEXRAZOXANE FOR INJECTION | Juno Pharmaceuticals Corp. | 02544091 | Powder For Solution - Intravenous | 500 MG / VIAL | N/A |
ZINECARD | 02153440 | Powder For Solution - Intravenous | 500 MG / VIAL | 12/31/1995 | |
ZINECARD | 02153432 | Powder For Solution - Intravenous | 250 MG / VIAL | 12/31/1995 | |
DEXRAZOXANE FOR INJECTION | hikma canada limited | 02557649 | Powder For Solution - Intravenous | 250 MG / VIAL | N/A |
DEXRAZOXANE FOR INJECTION | Juno Pharmaceuticals Corp. | 02544083 | Powder For Solution - Intravenous | 250 MG / VIAL | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CARDIOXANE 500 mg POLVO PARA SOLUCION PARA PERFUSION | 67673 | POLVO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
SAVENE 20 mg/ml POLVO PARA CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | 06350001 | POLVO Y DISOLVENTE PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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