Intravenously drip (within 30 minutes).
Gemcitabine is part of many chemotherapeutic regimens, therefore, when selecting the doses and the mode of administration of the drug in each individual case, you should refer to the special literature.
Non-small cell lung cancer. As a monotherapy, the recommended dose is 1000 mg / m2 1 time per week for 3 weeks followed by a weekly break, every 28 days. In combination with cisplatin gemcitabine is administered at a dose of 1250 mg / m2 on days 1 and 8 of each 21-day cycle or at a dose of 1000 mg / m2 on days 1, 8 and 15 of each 28-day cycle. Mammary cancer. With the progression of the disease after the first line of therapy, including or without anthracyclines (in contraindications to the use of anthracyclines) gemcitabine is used as a monotherapy in a dose of 1000-1200 mg / m2 on days 1, 8 and 15 every 28 days. In combination with paclitaxel, the drug is administered at a dose of 1250 mg / m2 on days 1 and 8 of each 21-day cycle.
Pancreas cancer. The recommended dose is 1000 mg / m2 1 time per week for 7 weeks followed by a one-week break. Follow-up cycles should consist of infusions, administered once a week for 3 weeks, followed by a one-week break.
Cancer of the bladder. The recommended dose is 1250 mg / m2 on days 1, 8 and 15 every 28 days with monotherapy or 1000 mg / m2 at 1, 8 and 15 days in combination with cisplatin, which is administered immediately after the administration of gemcitabine at a dose of 70 mg / m2 on the 1st or 2nd day of each 28-day cycle.
In case of development of hematological toxicity, the dose of gemcitabine can be reduced or its administration postponed according to the following scheme: with a quantity of granulocytes greater than 1000 / μl and platelets greater than 100,000 / μl, the full recommended dose is used; at quantitygranulocytes 500-1000 / μL or platelets 50,000- 100,000 / μL dose reduced to 75% of the recommended; if the number of granulocytes is less than 500 / μL or platelets less than 50,000 / μL, the introduction is postponed.
To detect non-hematologic toxicity, a regular examination of the patient and control of liver and kidney function should be carried out. Depending on the degree of toxicity, the dose can be reduced during each cycle or with the onset of a new cycle stepwise. The decision to delay the next administration of the drug should be based on the clinical assessment of the doctor's toxicity dynamics.
Patients with impaired liver and kidney function. Gemcitabine should be used with caution in patients with hepatic impairment or with impaired renal function. Studies in patients with significant impairment of liver and kidney function were not performed.
Moderate or moderate renal insufficiency (creatinine clearance from 30 ml / min to 80 ml / min) has no significant effect on the pharmacokinetics of gemcitabine. Elderly patients. Changes in the dosing regimen in patients older than 65 years are not required. Children. The use of gemcitabine in children has not been studied.
Rules of preparation of infusion solution.
To prepare a solution of Cytogem ®, only 0.9% sodium chloride solution should be used without preservatives. To dissolve 1000 mg of gemcitabine, at least 25 ml of solvent is added to the vial and shaken until the lyophilizate is completely dissolved. The maximum concentration of gemcitabine should not exceed 40 mg / ml. In solutions with a concentration of gemcitabine more than 40 mg / ml, incomplete dissolution is possible.
A prepared solution containing the desired dose of the preparation is diluted with a sufficient amount of 0.9% sodium chloride solution before administration for intravenous infusion for 30 minutes. Before the introduction, it should be ensured that there are no suspended particles in the solution.
The prepared solution can be stored at room temperature (15 to 30 ° C) for 24 hours; Do not freeze, as crystallization may occur.