Gemcitabine

Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.

Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in older people or those with performance status 2.

Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy.

Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.

PrGemcitabine Injection (gemcitabine hydrochloride) is indicated for the: • Treatment of patients with locally advanced (non-resectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas to achieve a Clinical Benefit Response (a composite measure of clinical improvement).

• Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) as either a single agent or in combination with cisplatin. • Treatment of patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder in combination with cisplatin.

• Treatment, in combination with paclitaxel, of patients with unresectable, locally recurrent or metastatic breast cancer, who have good performance status and have relapsed following adjuvant anthracycline-based chemotherapy. Gemcitabine Injection should be used only under the supervision of a qualified healthcare professional who is experienced in the use of chemotherapeutic agents and in the management of patients with cancer.

1 INDICATIONS AND USAGE Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

1 ) • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 2 ) • in combination with cisplatin for the treatment of non-small cell lung cancer.

3 ) • as a single agent for the treatment of pancreatic cancer. 1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.