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Doxorubicin Hydrochloride

DOXORUBICIN

Manufacturer: Amneal Pharmaceuticals LLC

Score: 145.0

Quick Summary

Doxorubicin Hydrochloride is an anthracycline topoisomerase inhibitor used to treat various types of cancer, including breast cancer, leukemia, lymphoma, and sarcoma. The drug works by intercalating DNA and inhibiting the synthesis of nucleic acids, leading to cell death. However, it can cause serious side effects, including cardiomyopathy, secondary malignancies, and severe myelosuppression. The recommended dosage is 60-75 mg/m2 every 21 days, and dose adjustments are necessary for patients with hepatic impairment or other specific conditions. Special considerations are needed for use in pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Adjuvant treatment of breast cancer
  • Treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, and other cancers
  • Indicated for metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, and other metastatic cancers

Important Safety Information

Warning

Cardiomyopathy, secondary malignancies, extravasation and tissue necrosis, and severe myelosuppression can occur with doxorubicin hydrochloride use

Contraindications

  • Severe myocardial insufficiency
  • Recent myocardial infarction
  • Severe persistent drug-induced myelosuppression
  • Severe hepatic impairment
  • Severe hypersensitivity reaction to doxorubicin hydrochloride

Adverse Reactions

  • Alopecia
  • Nausea and vomiting
  • Leukopenia
  • Thrombocytopenia
  • Cardiac dysfunction
  • Secondary malignancies

Dosing Recommendations

General Guidance

Dose adjustments necessary for patients with hepatic impairment or other specific conditions

Adjuvant breast cancer

Adult Dose

60 mg/m2 every 21 days

Pediatric Dose

Not recommended

Other cancers

Adult Dose

60-75 mg/m2 every 21 days

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

  • Avoid use during the 1st trimester
  • Use with caution during the 2nd and 3rd trimesters

Nursing Mothers

  • Use with caution
  • Monitor for adverse reactions in the infant

Pediatric Use

  • Use with caution
  • Monitor for late cardiovascular dysfunction

Geriatric Use

  • Use with caution
  • Monitor for adverse reactions