Gemtabin Dosage/Direction for Use

Adults: Non-Small Cell Lung Cancer: Single-Agent Use: Gemcitabine HCl should be administered by intravenous infusion at a dose of 1000 mg/m² over 30 minutes once weekly for up to 3 weeks (or until toxicity necessitates reducing or holding a dose), 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.
Combination Treatment: Two schedules have been investigated and the optimum schedule has not been determined. With the 4-week schedule, gemcitabine HCl should be administered intravenously at 1000 mg/m² over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m² on Day 1 after the infusion of gemcitabine HCl. With the 3-week schedule, gemcitabine HCl should be administered intravenously at 1250 mg/m² over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m² should be administered intravenously after the infusion of gemcitabine HCl on Day 1.
Pancreatic Cancer: Gemcitabine HCl should be administered by intravenous infusion at a dose of 1000 mg/m² over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), 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.
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-hour intravenous infusion before gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count 1500 x 10⁶/L and a platelet count ≥100,000 x 10⁶/L prior to each cycle.
Bladder Cancer: In combination treatment with cisplatin, gemcitabine HCl should be administered intravenously at 1000 mg/m² over 30 minutes on Days 1, 8, and 15 of each 28-day cycle, followed by a week of rest from treatment. In 28-day cycle, Cisplatin should be administered intravenously at 70 mg/m² on Day 1 after the infusion of gemcitabine HCl or Day 2. The 4- week cycle could be repeated. Before the chemotherapy, reduction of dosage and delay of prescription should be considered by the degree of patients' side effect. At the result of clinical test, combination treatment with 100 mg/m² of cisplatin may induce remarkable myelosuppression.
Patients receiving gemcitabine HCl should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines as follows. (See table.)

Click on icon to see table/diagram/image

Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine HCl should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.
Direction for Reconstitution: The recommended diluent for reconstitution of gemcitabine HCl is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for gemcitabine HCl upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.
To reconstitute, add 5 mL, 25 mL and 50 mL of 0.9% Sodium Chloride Injection to the 200 mg, 1 g and 2 g vials, respectively. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200-mg vial, 1.3 mL for the 1-g vial and 2.6 mL for the 2 g vial). The total volume upon reconstitution will be 5.26 mL, 26.3 mL and 52.6 mL respectively. Complete withdrawal of the vial contents will provide 200 mg, 1 g or 2 g of gemcitabine HCl. The appropriate amount of drug may be administered as prepared or further diluted with 0.9% Sodium Chloride Injection to concentrations as low as 0.1 mg/mL. Reconstituted gemcitabine HCl is a clear, colorless solution and is stable for 24 hours at controlled room temperature 20°C to 25°C. Discard unused portion. Solutions of reconstituted gemcitabine HCl should not be refrigerated, as crystallization may occur.
Caution should be exercised in handling and preparing gemcitabine HCl solutions. The use of gloves is recommended. If gemcitabine HCl solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.
Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.