HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ABRAXANE safely and effectively.  See full prescribing information for ABRAXANE.
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)
(albumin-bound)
Initial U.S. Approval: 2005
WARNING: NEUTROPENIA
See full prescribing information for complete boxed warning.
Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm3. (4)
It is recommended that frequent peripheral blood cell counts be performed to monitor the occurrence of bone marrow suppression. (4, 5.1, 6.1, 6.2, 6.3)
DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
RECENT MAJOR CHANGES
Dosage and Administration (2.4, 2.8)                                  12/2014
Warnings and Precautions, Hepatic Impairment (5.6)      12/2014
INDICATIONS AND USAGE
ABRAXANE is a microtubule inhibitor indicated for the treatment of:
Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (1.1)
Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. (1.2)
Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. (1.3)
DOSAGE AND ADMINISTRATION
Metastatic Breast Cancer: Recommended dosage of ABRAXANE is 260 mg/m2 intravenously over 30 minutes every 3 weeks. (2.1)
Non-Small Cell Lung Cancer: Recommended dosage of ABRAXANE is 100 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after ABRAXANE. (2.2)
Adenocarcinoma of the Pancreas: Recommended dosage of ABRAXANE is 125 mg/m2 intravenously over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle; administer gemcitabine on Days 1, 8 and 15 of each 28-day cycle immediately after ABRAXANE. (2.3)
Do not administer ABRAXANE to any patient with AST > 10 x ULN or bilirubin > 5 x ULN. Do not administer ABRAXANE to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. For diseases other than metastatic adenocarcinoma of the pancreas, reduce starting dose in patients with moderate to severe hepatic impairment. (2.4)
Dose Reductions: Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities. (2.5)
Use caution when handling cytotoxic drugs. Closely monitor the infusion site for extravasation and infiltration. No premedication is required prior to administration. (2.6)
DOSAGE FORMS AND STRENGTHS
For injectable suspension: lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-use vial for reconstitution. (3)
CONTRAINDICATIONS
Neutrophil counts of < 1,500 cells/mm3. (4)
Severe hypersensitivit