Gemita

The agent Gemcitabine is a cytostatic belonging to the therapeutic class of pyrimidine antimetabolite.

Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP. Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (selfpotentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death.

Recommended Dose and Schedule

Ovarian Cancer

The recommended dose of gemcitabine is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after gemcitabine administration on Day 1 of each 21-day cycle.

Breast Cancer

The recommended dose of gemcitabine is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before gemcitabine administration.

Non-Small Cell Lung Cancer

Every 4-week schedule

The recommended dose of gemcitabine is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine.

Every 3-week schedule

The recommended dose of gemcitabine is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine.

Pancreatic Cancer

The recommended dose of gemcitabine is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule is as follows: 

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

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

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

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 5-FU.

1 ml of reconstituted solution contains 38 mg Gemcitabine.

Strengths:

• Gemcitabine Injection (GEMITA® RTU) 200 mg/5.26 ml: In a 6 ml USP type-I, tubular clear colorless glass vial.
• Gemcitabine Injection (GEMITA® RTU): 1 g/26.3 ml: In a 30 ml USP type-I, tubular clear colorless glass vial.
• Gemcitabine Injection (GEMITA® RTU): 1.4 g/36.8 ml: In a 50 ml USP type-I, tubular clear colorless glass vial.

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory