Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)

PACLITAXEL

Manufacturer: TWi Pharmaceuticals, 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

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