INDICATIONS AND USAGE（适应症）

Ovarian Cancer

Gemcitabine 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.

Breast Cancer

Gemcitabine 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.

Non-Small Cell Lung Cancer

Gemcitabine in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).

Pancreatic Cancer

Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with fluorouracil.

DOSAGE（服用剂量）

Recommended Dose and Schedule for Ovarian Cancer

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with carboplatin AUC 4 administered intravenously on Day 1 after gemcitabine administration. Refer to carboplatin prescribing information for additional information.

Recommended Dose and Schedule for Breast Cancer

The recommended dosage of gemcitabine is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m2 administered as a 3-hour intravenous infusion on Day 1 before gemcitabine administration. Refer to paclitaxel prescribing information for additional information.

Recommended Dose and Schedule for Non-Small Cell Lung Cancer

28-day schedule

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine administration.

21-day schedule

The recommended dosage of gemcitabine is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine administration.

Refer to cisplatin prescribing information for additional information.

Recommended Dose and Schedule for Pancreatic Cancer

The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes. The recommended treatment schedule is as follows:

Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest.

After week 8: weekly dosing on Days 1, 8, and 15 of each 28-day cycle.

ADVERSE REACTIONS（不良反应）

Hypersensitivity

Schedule-Dependent Toxicity

Myelosuppression

Pulmonary Toxicity and Respiratory Failure

Hemolytic Uremic Syndrome

Hepatic Toxicity

Exacerbation of Radiation Therapy Toxicity

Capillary Leak Syndrome

Posterior Reversible Encephalopathy Syndrome

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a625c92b-c569-4b98-8d2e-2b3f5e12b34f/spl-doc?hl=Gemcitabine

Gemciteinformation