Fonkogem 1000mg powder for injection
Ferron Par Pharmaceuticals
Ingredients in every vial
|Gemcitabine HCl||1000 mg|
Each package contains
|ATC Level 1||L - Antineoplastic and immunomodulating agents|
|ATC Level 2||L01 - Antineoplastic Agents|
|ATC Level 3||L01B - Antimetabolites|
18 YEARS OLD AND ABOVE
Pancreatic cancer: gemcitabine should be administered by intravenous infusion at a dose of 1,000 mg/m² over 30 minutes once weekly for up to 7 weeks, followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.
Dose modifications: dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient.
Non-small cell lung cancer: two schedules have been investigated and the optimum schedule has not been determined. With the 4-weeks schedule, gemcitabine should be administered intravenously at 1,000 mg/m² over 30 minutes on days 1, 8, and 15 of each 28-day cycle. With the 3-weeks schedule, gemcitabine should be administered intravenously at 1,250 mg/m² over 30 minutes on days 1 and 8 of each 21-day cycle. Cisplatin has been used at doses between 75-100 mg/m² after administration of gemcitabine on day 1 of each 21-day or 28-day cycle. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patients.
Breast cancer: gemcitabine should be administered intravenously at a dose of 1,250 mg/m² over 30 minutes on days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m² on day 1 as a 3 hours intravenous infusion before gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patient should have an absolute granulocyte count 1,500 x 106/l and a platelet count >100,000 x 106/l prior to each cycle. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
Ovarian cancer: gemcitabine should be administered intravenously at a dose of 1,000 mg/m² over 30 minutes on days 1 and 8 of each 21-day cycle. Carboplatin (at the dose required to obtain an AUC of 4 mg/ml) should be administered intravenously on day 1 after gemcitabine administration. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity.
65 YEARS OLD AND ABOVE
Gemcitabine clearance and half-life are affected by age
UP TO 18 YEARS
There is no studies in the efficacy and safety of gemcitabine in children.
HEPATIC AND RENAL IMPAIRMENT
Gemcitabine should be used with caution in patients with hepatic insufficiency or with impaired renal function as there is insufficient information to allow clear dose recommendation for this patient population.
– Ovarian cancer
Gemcitabine in combination with carboplatin indicated for the treatment of patients with recurrent epithelial ovarian carcinoma who have relapsed following platinum-based therapy.
– Breast cancer
Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer who have relapsed following adjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
– Non-small cell lung cell
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) non-small cell lung cancer.
– Pancreatic cancer
Gemcitabine is indicated as first-line treatment for patients with locally advanced (non-resectable stage II or stage III) or metastatic (stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with 5-FU