Product Description

Paclitaxel for Injection (Albumin-bound)

Dosage form: powder for dispersion for infusion

Strength: 5 mg/mL

Description: White to yellow lyophilized cake or powder supplied in 50-mL borosilicate glass vial.

Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each mL of dispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.

Indication

1.1

Metastatic Breast Cancer

Paclitaxel for Injection is indicated for the treatment of 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.

1.2

Non-Small Cell Lung Cancer

Paclitaxel for Injection is indicated for the first-line treatment of locally advanced or metastatic non

small cell lung cancer, in combination with carboplatin, in patients who are not candidates

for curative surgery or radiation therapy.

1.3

Adenocarcinoma of the Pancreas

Paclitaxel for Injection is indicated for the first-line treatment of patients with metastatic

adenocarcinoma of the pancreas, in combination with gemcitabine.

Shelf life 36 months