Gemtero Dosage/Direction for Use

Non-small cell lung cancer: Combination use: Adults: Gemcitabine in combination with Cisplatin has been investigated using two dosing regimens. One regimen used a three-week schedule and the other used a four-week schedule.
The three-week schedule used Gemcitabine 1250 mg/m², given by 30 minutes intravenous infusion on days 1, 8 of each 21-day cycle. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
The four-week schedule used Gemcitabine 1000 mg/m², given by 30 minutes intravenous infusion on days 1, 8, and 15 of each 28-day cycle.
Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient. 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.
Single agent use: Adults: The recommended doses is 1000 mg/m², given by 30 minutes intravenous infusion. This should be repeated once weekly for three weeks, followed by one week rest period. This four weeks cycle is then repeated. Dosage reduction is applied based upon the amount of toxicity experienced by the patient.
Pancreatic cancer: Adults: The recommended dose of Gemcitabine is 1000 mg/m², given by 30 minutes intravenous infusion. This should be repeated once weekly for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of injections once weekly for 3 consecutive weeks out of every 4 weeks. Dosage reduction is applied based upon the amount of toxicity experienced by the patient.
Bladder Cancer: Combination use: Adults: The recommended dose of Gemcitabine is 1000 mg/m², given by 30 minutes infusion. The dose should be given on days 1, 8 and 15 of each 28 days cycle in combination with Cisplatin. Cisplatin is given at a recommended dose of 70 mg/m² on day 1 following Gemcitabine on day 2 of each 28 days cycle. This four weeks cycle is then repeated. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient. Myelosuppression is more common when Cisplatin was used in doses of 100 mg/m².
Breast cancer: Combination use: Adults: Gemcitabine in combination with Paclitaxel is recommended using Paclitaxel (175 mg/m²) administered on day 1 over approximately 3 hours as an intravenous infusion, followed by Gemcitabine (1250 mg/m²) as 30 minutes intravenous infusion on days 1 and 8 of each 21-day cycle. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient. Patients should have an absolute granulocyte count of at least 1500 (x10⁶/L) prior to initiation of Gemcitabine + Paclitaxel combination.
Ovarian cancer: Single agent use: Adults: The recommended dose of Gemcitabine is 800 - 1250 mg/m², given by a 30 minutes intravenous infusion. The dose should be given on days 1, 8 and 15 of each 28 cycles. This four weeks cycle is then repeated. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
Combination use: Adults: Gemcitabine in combination with Carboplatin is recommended using Gemcitabine 1000 mg/m² on days 1 and 8 of each 21-day cycle as a 30 minutes intravenous infusion. After Gemcitabine, Carboplatin will be given on day 1 consistent with a target AUC of 4.0 mg/mL/minute. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity. Patients receiving Gemcitabine should be monitored prior to each dose of platelet, leucocyte and granulocyte counts and, if necessary, the dose of Gemcitabine may be either reduced or withheld in the presence of haematological toxicity, according to the following scale: see table.


Click on icon to see table/diagram/image


For Cisplatin dosage adjustment in combination therapy, see the manufacturer's prescribing information.
Periodic checks of liver and kidney function, including transaminases and serum creatinine, should also be performed in patients receiving Gemcitabine.
Gemcitabine is well tolerated during the infusion, with only a few cases of injection site reaction reported.
Gemcitabine can be easily administered on an outpatient basis.
Elderly Patients: Gemcitabine has been well tolerated in patients over the age of 65. There is no evidence to suggest that dose adjustments are necessary in the elderly, although Gemcitabine clearance and half-life are affected by age.
Children: These studies did not provide sufficient data to establish efficacy and safety of Gemcitabine in children.
Hepatic and renal impairment: Gemcitabine should be used with caution in patient with hepatic insufficiency or with impaired renal function as there is insufficient information to allow clear dose recommendation for these patient population.