ARTG Entry
PACLITAXEL
ARTG entry for PACLITAXEL (paclitaxel), ARTG 168525 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Accord Healthcare
- Active ingredient: paclitaxel
- Therapeutic area: Oncology
What it is
Abraxane is nanoparticle albumin-bound paclitaxel, an albumin nanoparticle form of paclitaxel with a mean particle size of approximately 130 nanometres. Each vial contains paclitaxel and human albumin in the ratio of 1:9, with the paclitaxel contained within nanoparticles that consist of a majority of paclitaxel bound to human albumin. Each single-use vial contains paclitaxel 100 mg or 250 mg. Abraxane is free of solvents. Paclitaxel is a natural product with antitumour activity.
Approved indications
— Treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. — First-line treatment of non-small cell lung cancer in combination with carboplatin in patients who are not candidates for potentially curative surgery and/or radiation. — First-line treatment of patients with metastatic adenocarcinoma of the pancreas in combination with gemcitabine.
Dosing overview
No premedication to prevent hypersensitivity reactions is required prior to administration of Abraxane.
Key safety warnings
Patients who experience severe neutropenia or severe peripheral neuropathy during Abraxane therapy should have dosage reduced, with further reductions made for recurrence of these events. Abraxane should not be administered until neutrophil counts recover to greater than 1.5 × 10⁹/L. For patients with moderate to severe hepatic impairment, a 20% reduction in dose is recommended for indications of metastatic breast cancer and non-small cell lung cancer. There are insufficient data to permit dosage recommendations for patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment, and for patients with total bilirubin greater than 5 × ULN or AST greater than 10 × ULN regardless of indication. There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease.