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.
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.
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 It 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.
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.
Locally or metastatic cervical cancer
Combined therapy is used for this disease. With sequential chemoradiotherapy (neoadjuvant) gemcitabine is administered at a dose of 1250 mg / m2 on days 1 and 8 of each 21-day cycle. Cisplatinum is administered after administration of gemcitabine at a dose of 70 mg / m2 in the 1st day of the cycle against a background of hyperhydration.
With locally advanced cancer with simultaneous chemoradiotherapy gemcitabine is administered once a week 1-2 hours before the start of radiotherapy in a dose of 125 mg / m2 in combination with cisplatin in a dose of 40 mg / m2, which is introduced immediately after the administration of gemcitabine.
In case of development of hematological toxicity, the dose of Gemcitera can be reduced or its administration postponed in accordance with the following recommendations: with an absolute number of neutrophils (ACH) more than 1000 / μL and platelets more than 100,000 / μL, the full recommended dose is used; at an amount of ACHN 500-1000 / μL or platelets of 50,000-100,000 / μL the dose is reduced to 75% of the recommended dose; if the ACH 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.
For the preparation of Gemcitera solution, use only 0.9% sodium chloride solution without preservatives. To dissolve Gemcitera in a 200 mg bottle, add at least 5 ml of solvent, in a 1000 mg bottle - 25 ml of solvent, after which the vial is 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 store in the refrigerator, as crystallization may occur.