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PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND

PACLITAXEL

Manufacturer: American Regent, Inc.

Score: 141.0

Quick Summary

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor used for the treatment of metastatic breast cancer, non-small cell lung cancer, and adenocarcinoma of the pancreas. The drug has a boxed warning for severe myelosuppression and is contraindicated in patients with baseline neutrophil counts of less than 1,500 cells/mm^3 or a history of severe hypersensitivity reactions to the drug. The recommended dosages vary by condition, with 260 mg/m^2 every 3 weeks for metastatic breast cancer, 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for non-small cell lung cancer, and 125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle for adenocarcinoma of the pancreas. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Metastatic breast cancer
  • Non-small cell lung cancer
  • Adenocarcinoma of the pancreas

Important Safety Information

Warning

Severe myelosuppression

Contraindications

  • Baseline neutrophil counts of less than 1,500 cells/mm^3
  • History of severe hypersensitivity reactions to the drug

Adverse Reactions

  • Neutropenia
  • Sensory neuropathy
  • Fatigue
  • Nausea
  • Diarrhea

Dosing Recommendations

General Guidance

Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities.

Metastatic breast cancer

Adult Dose

260 mg/m^2 every 3 weeks

Pediatric Dose

Not established

Non-small cell lung cancer

Adult Dose

100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle

Pediatric Dose

Not established

Adenocarcinoma of the pancreas

Adult Dose

125 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Can cause fetal harm
  • Advise females of reproductive potential of the potential risk to a fetus

Nursing Mothers

  • Not established

Pediatric Use

  • Not established
  • Pharmacokinetics, safety, and antitumor activity of protein-bound paclitaxel were assessed in an open-label, dose escalation, dose expansion study in 96 pediatric patients

Geriatric Use

  • No overall difference in effectiveness was observed between patients 65 years or older and younger patients
  • Higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years or older