Gemita Dosage/Direction for Use

1. Standard Dosing: Non-small cell lung cancer: Single-agent use: Adults: The recommended dose of gemcitabine is 1,000 mg/m², given by 30 minutes intravenous infusion. This should be repeated once weekly for three weeks, follows by a one week rest period. This four week 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 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 1,250 mg/m², given by 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.
The four week schedule used gemcitabine 1,000 mg/m², given by 30 minutes intravenous infusion, on days 1, 8, 15 of each 28 days cycle. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
Pancreatic Cancer: Adults: The recommended dose of gemcitabine is 1,000 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 with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patients.
Breast Cancer: Combination use: Adults: Gemcitabine in combination with paclitaxel: paclitaxel (175 mg/m²) administered on Day 1 over approximately 3 hours as an intravenous infusion, followed by gemcitabine (1,250 mg/m²) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle. Dose 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 1,500 (x10⁶/L) prior to initiation of gemcitabine+paclitaxel combination.
Bladder Cancer: Combination use: Adults: The recommended dose of gemcitabine is 1,000 mg/m², given by 30-minutes intravenous infusion. The does should be given on Days 1, 8 and 15 of each 28 day cycle in combination with cisplatin. 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 with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patients. A clinical trial showed more myelosuppression when cisplatin was used in doses of 100 mg/m².
Ovarian Cancer: Single-agent use: Adults: The recommended dose of gemcitabine is 800-1,250 mg/m², given by a 30-minute intravenous infusion. The dose should be given on Days 1, 8 and 15 of each 28-day cycle. This four week 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 1,000 mg/m² administered on Days 1 and 8 of each 21-day cycle as a 30-minute intravenous infusion. After gemcitabine, carboplatin will be given on Day 1 consistent with a target AUC of 4.0 mg/ml.min. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
Biliary Tract Cancer: Single-agent use: Adults: The recommended dose of gemcitabine is 1,000 mg/m², given by 30-minute intravenous infusion. This should be repeated once weekly for three weeks, followed by a one week rest period. This four week 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 cisplatin is recommended using cisplatin 70 mg/m² on Day 1 as an intravenous infusion, followed by gemcitabine 1,250 mg/m² administered on Days 1 and 8 of each 21 day cycle, given as a 30-minute intravenous infusion. This three week 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.
Cervical Cancer: Combination therapy using radiation and cisplatin: In combination therapy using radiation plus cisplatin 40 mg/m² followed immediately by gemcitabine 125 mg/m² IV infusion once weekly for 6 weekly (days 1, 8, 15, 22, 29 and 36) at 1-2 hr before concurrent pelvic radiation therapy of 50.4 Gy external beam radiation delivered to entire field of radiation in 28 fractions, i.e. 1.8 Gy/day, 5 days/week over the 6 week of chemotherapy, followed by 2 adjuvant 21-day cycles of gemcitabine (1,000 mg/m² on day 1 and day 8) plus cisplatin (50 mg/m² on day 1 of each cycle).
2. Monitoring, Dose Adjustments or Titration, Method of Terminating Treatment: Patients receiving gemcitabine should be monitored prior to each dose for platelet, leucocyte and granulocyte count 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

Periodic physical examination and checks of renal and hepatic function should be made to detect non-haematologic toxicity. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
Doses should be withheld until toxicity has resolved in the opinion of the physician.
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. 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.
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 from clinical studies to allow clear dose recommendation for this patient population.
Mild to moderate renal insufficiency (GFR from 30 mL/min to 80 mL/min) has no consistent, significant effect on gemcitabine pharmacokinetics.
Children: Gemcitabine has been studied in limited Phase I and II trials in children in a variety of tumor types. These studies did not provide sufficient data to establish the efficacy and safety of gemcitabine in children.