Product Dossier
ABRAXANE
Product Dossier for ABRAXANE (paclitaxel, Abraxis BioScience). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Abraxis BioScience
- Active ingredient: paclitaxel
- Therapeutic area: Oncology
- Related brand: ANZATAX
- Related brand: TEKNOXEL
- Related brand: PACLIALL
- Same area: TALZENNA
- Same area: ZARZIO
What it is
ABRAXANE is a paclitaxel, a natural product with antitumour activity. It is an albumin nanoparticle form of paclitaxel with a mean particle size of approximately 130 nanometres. The paclitaxel is contained within nanoparticles that consist of a majority of paclitaxel bound to human albumin. ABRAXANE is free of solvents. It is supplied as a powder for injection (suspension). Each single-use vial contains 100 mg or 250 mg of paclitaxel.
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 (neutrophil <0.5 x 10⁹/L for a week or longer) or severe peripheral neuropathy during ABRAXANE therapy should have dosage reduced. For recurrence of severe neutropenia or severe peripheral neuropathy, further dose reduction should be made. ABRAXANE should not be administered until neutrophil counts recover to >1.5 x 10⁹/L. For grade 3 peripheral neuropathy, hold treatment until resolution to grade 1 or 2, followed by a dose reduction for all subsequent courses of ABRAXANE.
Contraindications
The provided documents do not contain information about contraindications.
PBS listing
The provided documents do not contain information about PBS listing, restrictions, or pricing.
Regulatory history
ABRAXANE 100 mg powder for injection was first listed on the ARTG on 17 October 2008. An AusPAR (Australian Public Assessment Report) was approved on 13 March 2014 for the indication of ABRAXANE in combination with gemcitabine for first-line treatment of patients with metastatic adenocarcinoma of the pancreas. ABRAXANE 250 mg powder for injection was first listed on the ARTG on 7 December 2018.