Gemcitabine is administered intravenously drip for 30 minutes.
Non-small cell lung cancer (locally advanced or disseminated)
Myotheapia. The recommended dose of the drug is 1000 mg / m2 1 time per week for 3 weeks with a subsequent one-week break, every 28 days. Combined therapy. The recommended dose of the drug is 1250 mg / m2 on days 1 and 8 of each 21-day cycle or 1000 mg / m2 on days 1, 8 and 15 of each 28-day cycle. Cisplatinum is administered at a dose of 70 mg / m2 in the 1st day of the cycle after the infusion of gemcitabine against a background of hyperhydration.
Breast cancer (locally advanced or disseminated)
Monotherapy. With the progression of the disease after the first line of therapy,including anthracyclines or without them (for contraindications to the use of anthracyclines), the recommended dose of the drug is 1000-1200 mg / m2 on days 1, 8 and 15 every 28 days.
Combined therapy. As first-line therapy, with the progression of neoadyovant therapy, with the inclusion of anthracyclines. The recommended dose of the drug is 1250 mg / m2 at 1 and 8 days in combination with paclitaxel at a dose of 175 mg / m2 approximately 3 hours after the administration of gemcitabine on day 1 of each 21-day cycle.
Bladder cancer (locally advanced, disseminated or superficial)
Monotherapy. The recommended dose of the drug is 1250 mg / m2 on days 1, 8 and 15 every 28 days. Combined therapy. The recommended dose of the drug is 1000 mg / m2- at 1, 8 and 15 days in combination with cisplatin, which is administered at a dose of 70 mg / m2 immediately after the infusion of gemcitabine on or on day 2 of each 28-day cycle.
Intravesical chemotherapy. The recommended dose of the drug is 2000 mg. To obtain a solution for instillation, the drug is dissolved in 100 or 50 ml of a 0.9% solution of sodium chloride to a concentration of 20 to 40 mg / ml. The exposure is 60 minutes. It is administered once a week for 6 weeks. The concentration of the solution should not exceed 40 mg / ml.
Epithelial ovarian cancer (locally advanced or disseminated).
Monotherapy. The recommended dose of the drug is 800-1250 mg / m2 on days 1, 8 and 15 every 28 days.
Combined therapy. The recommended dose of the drug is 1000 mg / m2 at 1 and 8 days in combination with carboplatin, which is administered immediately after the infusion of gemcitabine on day 1 of each 21-day cycle.
Pancreatic cancer (locally advanced or disseminated).
Monotherapy. The recommended dose of the drug is 1000 mg / m2 Once a week for 7 weeks followed by a weekly break. The subsequent cycles should consist of infusions, carried out once a week for 3 weeks with a subsequent one-week break.
Cervical cancer (locally advanced or disseminated).
Combined therapy. With locally advanced cancer with sequential chemoradiotherapy (neoadjuvant) and disseminated cancer gemcitabine is administered at a dose of 1250 mg / m2 on days 1 and 8 of the 21-day cycle. Cisplatinum is administered after administration of gemcitabine at a dose of 70 mg / m2 in a 1 day cycle every 21 days against a background of hyperhydration.
With locally advanced cancer with simultaneous chemoradiotherapy once a week for 1-2 hours before the start of radiotherapy is introduced gemcitabine in a dose of 125 mg / m2 with the subsequent (immediately after the introduction of gemcitabine) by the administration of cisplatin in a dose of 40 mg / m2.
In case of development of hematological toxicity, the dose of gemcitabine can be reduced, or its administration postponed in accordance with the following scheme:
| The absolute amount of granulocytes (in 1 μl) | The number of platelets (in 1 μl) | % of previous dose |
| > 1000 | and | >100000 | 100 |
| 500- 1000 | or | 50000- 100000 | 75 |
| <500 | or | < 50000 | Postpone the introduction |
To detect non-hematologic toxicity, a regular examination of the patient and control of the functions of the liver and kidneys 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 a clinical assessment by the doctor of the toxicity dynamics.
Special patient groups
Elderly patients: evidence that suggests that elderly patients need to adjust the dose is not available, although gemcitabine clearance and half-life with age vary.
Patients with impaired hepatic and renal function: use gemcitabine in patients with hepatic insufficiency or with impaired renal function should be taken with caution, since there is insufficient data on the use of the drug in this category of patients.Mild or moderate severity of renal failure (creatinine clearance from 30 mL / min to 80 mL / min) does not have a significant effect on the pharmacokinetics of gemcitabine.
Children: the use of gemcitabine in children has not been studied.
Rules for the preparation of an infusion solution
As a solvent, only 0.9% solution of sodium chloride is used (without preservatives).
To prepare a solution for infusions, the contents of the 200 mg bottle are dissolved in at least 5 ml, and 1 g in not less than 25 ml of a 0.9% solution of sodium chloride for injection. Each vial is gently shaken until the lyophilizate is completely dissolved. The resulting solution should be clear.
The maximum concentration of gemcitabine should not exceed 40 mg / ml. Solutions prepared with a concentration higher than 40 mg / ml may be accompanied by incomplete dissolution.
A prepared Gemcitovera solution containing the desired dose of the drug is diluted with a sufficient amount of 0.9% sodium chloride solution for injection before administration, for a 30-minute intravenous infusion.
Before parenteral administration, it is necessary to visually monitor the prepared solution for mechanical impurities and discoloration.