Paclitaxel (Albumin-Bound)

Note: the content below does not include all the information needed to use Paclitaxel (Albumin-Bound) safely and effectively.

INDICATIONS AND USAGE

It is a microtubule inhibitor indicated for the treatment of:

1. 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.
2. 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.
3. Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

DOSAGE AND ADMINISTRATION

1. Metastatic Breast Cancer: Recommended dosage is 260 mg/m2 intravenously over 30 minutes every 3 weeks.
2. Non-Small Cell Lung Cancer: Recommended dosage 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 the use of drug.
3. Adenocarcinoma of the Pancreas: Recommended dosage 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 use of the drug.
4. Hepatic Impairment: Do not administer ABRAXANE to any patient with AST > 10 x ULN or bilirubin > 5 x ULN. Do not administer the drug 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.
5. Dose Reductions: Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities.
6. Use caution when handling cytotoxic drugs. Closely monitor the infusion site for extravasation and infiltration. No premedication is required prior to administration.

DOSAGE FORMS AND STRENGTHS

For injectable suspension: white to yellow, sterile, lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution.