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Dexrazoxane

DEXRAZOXANE

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 142.0

Quick Summary

Dexrazoxane is a cardioprotective agent used to reduce the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer. The recommended dosage ratio of dexrazoxane to doxorubicin is 10:1. Dexrazoxane is contraindicated in patients with non-anthracycline chemotherapy regimens. The most common adverse reactions include pain on injection, nausea, vomiting, fatigue, and alopecia. Dexrazoxane can cause fetal harm when administered to pregnant women and is not recommended for use in pediatric patients.

Key Clinical Findings and Indications

  • Reduces the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer
  • Indicated for use in patients who have received a cumulative doxorubicin dose of 300 mg/m2 and will continue to receive doxorubicin therapy

Important Safety Information

Warning

Dexrazoxane can cause fetal harm when administered to pregnant women

Contraindications

  • Non-anthracycline chemotherapy regimens

Adverse Reactions

  • Pain on injection
  • Nausea
  • Vomiting
  • Fatigue
  • Alopecia

Dosing Recommendations

General Guidance

Reduce dose by 50% in patients with moderate to severe renal impairment (creatinine clearance values less than 40 mL/min)

Metastatic breast cancer

Adult Dose

500 mg/m2 dexrazoxane for injection to 50 mg/m2 doxorubicin

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Dexrazoxane can cause fetal harm when administered to pregnant women
  • Pregnancy Category D

Nursing Mothers

  • It is not known whether dexrazoxane or its metabolites are excreted in human milk
  • A decision should be made whether to discontinue nursing or discontinue the drug

Pediatric Use

  • The safety and effectiveness of dexrazoxane in pediatric patients have not been established

Geriatric Use

  • Clinical studies of dexrazoxane did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects
  • Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range

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