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Combination use with Cisplatin: 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 (1250 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 (x 106/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 dose 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 myelosupression when cisplatin was used in doses of 100 mg/m2.
Ovarian Cancer: Single-agent use: Adults: The recommended dose of gemcitabine is 800-1250 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 1000 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 1000 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 1250 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: Gemcitabine in combination with cisplatin is recommended using 40 mg/m2 followed immediately by gemcitabine 125 mg/m2 by IV infusion once weekly for 6 weeks (days 1, 8, 15, 22, 29 and 36), 1 to 2 hr before concurrent pelvic radiation therapy. Radiation therapy should be 50.4 Gy external beam radiation delivered to the entire field of radiation in 28 fractions, i.e. 1.8 Gy/day, 5 days/week over the 6 weeks of chemotherapy, followed by 2 adjuvant 21-day cycles of gemcitabine (1000 mg/m2 on day 1 and day 8) plus cisplatin (50 mg/m2 on day 1 of each cycle).
Dose Modification: Recommended gemcitabine dose modifications for myelosuppression are described in the following tables. (See Tables 1-4.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageDose Modifications for Non-Hematologic Adverse Reactions: Permanently discontinue gemcitabine for any of the following: Unexplained dyspnea or other evidence of severe pulmonary toxicity; Severe hepatic toxicity; Hemolytic-Uremic Syndrome or severe renal impairment; Capillary Leak Syndrome; Posterior reversible encephalopathy syndrome.
Withhold gemcitabine or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological adverse reactions until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.
Preparation and Administration Precautions: Exercise caution and wear gloves when preparing Gemcitabine solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.
Instructions for dilution: The approved diluent for dilution of Gemcitabine Injection 38 mg/ml is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).
Total quantity of Gemcitabine Injection required for an individual patient must be diluted, before use, to at least 500 ml of sodium chloride 9 mg/ml solution for injection to obtain clinically relevant concentrations. Further dilution with the same diluent can be done.
Based on the recommended dose (1000 mg/m2 and 1250 mg/m2) and body surface area (between 1.0 m2 to 2.0 m2) a concentration range of 2 mg/ml to 5 mg/ml is obtained.
The osmolality and pH range of the diluted injection is also provided for reference. (See Table 5.)
Click on icon to see table/diagram/imageThe following instructions for dilution should be strictly followed in order to avoid adverse events.
1. Use aseptic technique during dilution of gemcitabine for intravenous infusion administration.
2. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
Shelf life after dilution: Chemical and physical in use stability after dilution in 0.9%w/v sodium chloride solution at concentration of 0.1 mg/ml, 1 mg/ml and 25 mg/ml has been demonstrated for 7 days at 2°C to 8°C or at 25°C.
Additional in use stability after dilution in 0.9%w/v sodium chloride solution at concentration of 0.1 mg/ml and 5 mg/ml has been demonstrated for 7 days at 2°C to 8°C or at 30°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
