pharmacopeia
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/api/v1/drug/dexrazoxane

Mechanism of action

Sourced from openFDA

The mechanism by which dexrazoxane for injection exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes.

Indications

Sourced from openFDA
  • Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )] .ICD-10: C50.919

Contraindications

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  • Do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. Dexrazoxane for injection should not be used with non-anthracycline chemotherapy regimens.contraindicated

Dosage & administration

Sourced from openFDA

Reconstitute vial contents and dilute before use. (2.3) Administer Dexrazoxane for injection by intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. ( 2.1 , 2.3 ) The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. ( 2.1 ) Reduce dose by 50% for patients with creatinine clearance <40 mL/min. ( 2.2 , 8.7 ) 2.1 Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion. 2.2 Dose Modifications Dosing in Patients with Renal Impairment Reduce dexrazoxane for injection dosage in patients with moderate to severe renal impairment (creatinine clearance values less than 40 mL/min) by 50% (dexrazoxane for injection to doxorubicin ratio reduced to 5:1; such as 250 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin) [see Use in Specific Populations (8.6 ) and Clinical Pharmacology (12.3 )] .

Warnings & precautions

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Myelosuppression: Dexrazoxane for injection may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. (5.1) Embryo-Fetal Toxicity: Can cause fetal harm. Advise female patients of reproductive potential of the potential hazard to the fetus. ( 5.5 , 8.1 ) 5.1 Myelosuppression Dexrazoxane for injection may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane for injection and chemotherapy only when adequate hematologic parameters are met. 5.2 Concomitant Chemotherapy Only use dexrazoxane for injection in those patients who have received a cumulative doxorubicin dose of 300 mg/m 2 and are continuing with doxorubicin therapy. Do not use with chemotherapy initiation as dexrazoxane for injection may interfere with the antitumor activity of the chemotherapy regimen. In a trial conducted in patients with metastatic breast cancer who were treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC) with or without dexrazoxane for injection starting with their first cycle of FAC therapy, patients who were randomized to receive dexrazoxane for injection had a lower response rate (48% vs. 63%) and shorter time to progression than patients who were randomized to receive placebo. 5.3 Cardiac Toxicity Treatment with dexrazoxane for injection does not completely eliminate the risk of anthracycline-induced cardiac toxicity.

Adverse reactions

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In clinical studies, dexrazoxane for injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving dexrazoxane for injection versus placebo. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The adverse reaction profile described in this section was identified from randomized, placebo- controlled, double-blind studies in patients with metastatic breast cancer who received the combination of the FAC chemotherapy regimen with or without dexrazoxane for injection. The dose of doxorubicin was 50 mg/m 2 in each of these trials. Treatment was administered every three weeks until disease progression or cardiac toxicity. Patients in clinical trials who received FAC with dexrazoxane for injection experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without dexrazoxane for injection [see Warnings and Precautions (5.1 )] . Table 1 below lists the incidence of adverse reactions for patients receiving FAC with either dexrazoxane for injection or placebo in the breast cancer studies.

Use in specific populations

Sourced from openFDA

Nursing Mothers: Discontinue drug or nursing. (8.3) 8.1 Pregnancy Teratogenic Effects. Pregnancy Category D Risk Summary Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.5)] . Animal Data Dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m 2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) when given daily to pregnant rats during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m 2 basis) were embryotoxic and teratogenic.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of dexrazoxane have been studied in advanced cancer patients with normal renal and hepatic function. The pharmacokinetics of dexrazoxane can be adequately described by a two-compartment open model with first-order elimination.

Overdosage

Sourced from openFDA

There are no data on overdosage in the cardioprotective trials; the maximum dose administered during the cardioprotective trials was 1000 mg/m 2 every three weeks. Disposition studies with dexrazoxane for injection have not been conducted in cancer patients undergoing dialysis, but retention of a significant dose fraction (>0.4) of the unchanged drug in the plasma pool, minimal tissue partitioning or binding, and availability of greater than 90% of the systemic drug levels in the unbound form suggest that it could be removed using conventional peritoneal or hemodialysis. There is no known antidote for dexrazoxane. Instances of suspected overdose should be managed with good supportive care until resolution of myelosuppression and related conditions is complete. Management of overdose should include treatment of infections, fluid regulation, and maintenance of nutritional requirements.

Approval history

Sourced from openFDA
  • Sep 28, 2004ANDAANDA076068Hikma
  • Oct 19, 2011ANDAANDA200752Eugia Pharma
  • Nov 28, 2016ANDAANDA207321Gland
  • Mar 26, 2025ANDAANDA216748Msn

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
895 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Febrile Neutropenia13715%
  2. 2Off Label Use12814%
  3. 3Neutropenia10312%
  4. 4Product Use Issue546.0%
  5. 5Pyrexia525.8%
  6. 6Nausea424.7%
  7. 7Myelosuppression414.6%
  8. 8White Blood Cell Count Decreased384.2%
  9. 9Vomiting364.0%
  10. 10Platelet Count Decreased353.9%
  11. 11Anaemia343.8%
  12. 12Cardiotoxicity343.8%
  13. 13Decreased Appetite333.7%
  14. 14Product Use In Unapproved Indication333.7%
  15. 15Neutrophil Count Decreased323.6%

Literature

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Recent PubMed references pinned to Dexrazoxane as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 63 ClinicalTrials.gov registrations naming Dexrazoxane as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dexrazoxane work?
The mechanism by which dexrazoxane for injection exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes.
What is Dexrazoxane used for?
According to FDA labeling, Dexrazoxane carries indications including: Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dexrazoxane?
Dexrazoxane is classified as Detoxifying agents for antineoplastic treatment, Cytoprotective Agent, Chelating Activity, Unknown Cellular or Molecular Interaction.
What are the brand names for Dexrazoxane?
Dexrazoxane is marketed under brand names including Totect.
What are the contraindications for Dexrazoxane?
Dexrazoxane labeling lists contraindications including: Do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. Dexrazoxane for injection should not be used with non-anthracycline chemotherapy regimens.. Always consult the full prescribing information and a clinician.
Note. Data for dexrazoxane is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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