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DOCETAXEL

DOCETAXEL ANHYDROUS

Manufacturer: Ingenus Pharmaceuticals, LLC

Score: 145.0

Quick Summary

Docetaxel is an antineoplastic agent used for the treatment of various cancers, including breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. It works by disrupting the microtubular network in cells, leading to inhibition of mitosis and cell death. The recommended dose of Docetaxel varies by indication and is typically administered intravenously every 3 weeks. Important safety information includes the risk of toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention. Contraindications include hypersensitivity to Docetaxel or polysorbate 80, and neutrophil counts of <1500 cells/mm^3. Special population considerations include use in pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Breast cancer: locally advanced or metastatic breast cancer after failure of prior chemotherapy
  • Non-small cell lung cancer: locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy
  • Prostate cancer: metastatic castration-resistant prostate cancer
  • Gastric adenocarcinoma: advanced gastric adenocarcinoma
  • Head and neck cancer: induction treatment of locally advanced squamous cell carcinoma of the head and neck

Important Safety Information

Warning

TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

Contraindications

  • Hypersensitivity to Docetaxel or polysorbate 80
  • Neutrophil counts of <1500 cells/mm^3

Adverse Reactions

  • Infections
  • Neutropenia
  • Anemia
  • Febrile neutropenia
  • Hypersensitivity reactions
  • Thrombocytopenia
  • Neuropathy
  • Dysgeusia
  • Dyspnea
  • Constipation
  • Anorexia
  • Nail disorders
  • Fluid retention
  • Asthenia
  • Pain
  • Nausea
  • Diarrhea
  • Vomiting
  • Mucositis
  • Alopecia
  • Skin reactions
  • Myalgia

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on neutrophil counts, liver function, and other factors.

Breast cancer

Adult Dose

60 mg/m^2 to 100 mg/m^2 every 3 weeks

Pediatric Dose

Not established

Non-small cell lung cancer

Adult Dose

75 mg/m^2 every 3 weeks

Pediatric Dose

Not established

Prostate cancer

Adult Dose

75 mg/m^2 every 3 weeks

Pediatric Dose

Not established

Gastric adenocarcinoma

Adult Dose

75 mg/m^2 every 3 weeks

Pediatric Dose

Not established

Head and neck cancer

Adult Dose

75 mg/m^2 every 3 weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Docetaxel can cause fetal harm when administered to a pregnant woman
  • Use in pregnancy is not recommended unless the potential benefits outweigh the risks

Nursing Mothers

  • It is not known whether Docetaxel is excreted in human milk
  • Use in nursing mothers is not recommended unless the potential benefits outweigh the risks

Pediatric Use

  • The efficacy and safety of Docetaxel in pediatric patients have not been established
  • Use in pediatric patients is not recommended unless the potential benefits outweigh the risks

Geriatric Use

  • Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy
  • Elderly patients may be more susceptible to the toxicities of Docetaxel