• Dosage

– Non-small cell lung cancer

+ Single-agent use: In adults, the recommended gemcitabine dose of 1000 mg/m² given as 30 minutes intravenous infusion. This should be repeated once weekly for 3 weeks. Followed by a one week rest period, this four week cycle is then repeated. Dosage reduction based upon the level of toxicity experienced by the patient. 

+ Combination use:  In adults, gemcitabine in combination with cisplatin has been investigated using two dosage regimens:

The 3-week schedule: Gemcitabine should be administered intravenously at 1250 mg/m² over 30 minutes on Days 1 and 8 of each 21-day cycle. The three week schedule used cisplatin 75 – 100 mg/m² on Day 1 of each 21-day cycle before the administration of gemcitabine. Dosage reduction based upon the level of toxicity experienced by the patient. 

The 4-week schedule: Gemcitabine should be administered intravenously at 1000 mg/m² over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. The four week schedule used cisplatin 75 – 100 mg/m² on day 1 of each 21-day cycle after the administration of gemcitabine. Dosage reduction based upon the level of toxicity experienced by the patient.

– Pancreatic cancer: In adults, the recommended dose of gemcitabine is 1000 mg/m² given by 30 minutes intravenous infusion. This dose should be repeated once weekly for 3 weeks followed by a week of rest. This four week cycle is then repeated. Dosage reduction based upon the level of toxicity experienced by the patient.

– Bladder cancer: In patients with bladder cancer who cannot tolerate cisplatin-based combinations, gemcitabine monotherapy should be considered a treatment option.

+ Single-agent use: In adults, the recommended dose of gemcitabine is 1250 mg/m², given by 30 minutes intravenous infusion on Days 1, 8, and 15 of 28-day cycle. This four week cycle is then repeated. 

+ Combination use: In adults, in combination with cisplatin, the recommended dose of gemcitabine is 1000 mg/m², given by 30 minutes intravenous infusion. The dose should be given on Days 1, 8, and 15 of 28-day cycle. Cisplatin is given at a recommended dose of 70 mg/m² on Day 1 following gemcitabine or Day 2 of each 28 day cycle. This four week cycle is then repeated. Dosage reduction based upon the level of toxicity experienced by the patient. A clinical trial showed more myelosuppression when cisplatin was used in doses of 100 mg/m².

– Breast cancer: In adults, Gemcitabine in combination with paclitaxel, gemcitabine (1250 mg/m²) is recommended given by 30 minutes intravenous infusion on Days 1 and 8 of 21-day cycle. Paclitaxel (175 mg/m²) is given over 3 hour intravenous infusion on Days 1, after the administration of gemcitabine. 

» Note: 

* Patients receiving gemcitabine should be monitored prior to each dose for platelet, leococyte and granulocyte counts and, if there is evidence of toxicity, the dose of gemcitabine should be reduced or withheld.

* Liver and kidney functions including transaminases and serum creatinine should also be followed in patients receiving this drug. 

* Gemcitabine is well tolerated during the infusion with only a few cases of injection site reaction reported. There have been no reports of injection site necrosis.

* Geriatrics: Gemcitabine has been well tolerated in patients over the age of 65. There is no evidence that further dose adjustments, although clearance and half life of gemcitabine are affected by age.

* Renal or Hepatic Impairment: Gemcitabine should be used with caution in patients with renal or hepatic insufficiency. No data are available in patients with significant renal or hepatic impairment.

* Children: Gemcitabine has not been established in children. 

• Administration

– Only use sterile 0,9% Sodium Chloride injection without preservatives, to prepare sterile gemcitabine solution. Although no confirmed interactions have been reported, with the use of gemcitabine, do not mix prepared gemcitabine solution with other drug. Due to the solubility of gemcitabine, prepare gemcitabine solution with maximum concentration of 40 mg/ml. Don’t get the gemcitabine solution with concentration greater than 40 mg/ml, because it may result in incomplete dissolution.

– To reconstitute, add at least 5 ml of 0,9% Sodium chloride Injection to the 200 mg vial or at least 25 ml of 0,9% Sodium chloride Injection to the 1 g vial. Invert to dissolve.

– Prepared gemcitabine solution should be stored at 15-30°C for 24 hours. Remove the unused drugs. Should not be stored gemcitabine solution in cold condition, because it may recrystallize. Should be observed before using drugs to detect small particles in medicine or change the color of the drug.