Gemcitabine is administered intravenously drip for 30 minutes. Gemcitabine is part of many chemotherapeutic regimens, and therefore, in selecting individual doses and the mode of administration of the drug in each individual case, reference should be made to special literature.
Non-small cell lung cancer (locally advanced or disseminated)
Monotherapy. 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.
Combined therapy. 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. Cisplatinum is administered at a dose of 70 mg / m2 the first 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 or without anthracyclines (with contraindication to the use of anthracyclines), gemcitabine is applied in a dose of 1000-1200 mg / m2 on days 1, 8 and 15 every 28 days.
Combined therapy. As first-line therapy, with the progression of neoadjuvant 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 on days 1, 8 and 15 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.
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. Subsequent cycles should consist of infusions, conducted once a week for 3 weeks, followed by a weekly 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 the administration of gemcitabine at a dose of 70 mg / m2 per day of the cycle every 21 days against 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 Gemcitar® can be reduced or postponed.
When using Gemcitar® in patients with bladder cancer in monotherapy or in combination with cisplatin in the case of development of hematologic toxicity, the change in the dosing regimen is performed in accordance with the following scheme:
| The absolute amount of neutrophils (in 1 μl) |
| The number of platelets (in 1 μl) | % of previous dose |
| >1000 | and | >100 000 | 100 |
| 500-1000 | and / or | 50 000-100 000 | 75 |
| <500 | and / or | <50 000 | Postpone introduction |
When using Getsitar® in patients with breast cancer in combination with paclitaxel in the case of development of hematological toxicity, the change in the dosing regimen is performed in accordance with the following scheme:
| The absolute amount of neutrophils (in 1 μl) |
| The number of platelets (in 1 μl) | % of previous dose |
| ≥1200 | and | >75 000 | 100 |
| 1000-1200 | and / or | 50 000-75 000 | 75 |
| 700-1000 | and / or | ≥50 000 | 50 |
| <700 | and / or | <50 000 | postpone the introduction |
When Gemcit® is used in patients with ovarian cancer in combination with carboplatin in the case of development of hematological toxicity, the change in the dosing regimen is performed in accordance with the following scheme:
| The absolute amount of neutrophils (in 1 μl) |
| The number of platelets (in 1 μl) | % of previous dose |
| >1500 | and | >100 000 | 100 |
| 1000-1500 | and / or | 75 000-100 000 | 50 |
| <1000 | and / or | <75 000 | Postpone introduction |
The dose of gemcitabine should be reduced to 75% of the baseline in all subsequent cycles of chemotherapy in the following cases:
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decrease in the absolute number of granulocytes less than 500 per μL for more than 5 days
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decrease in the absolute number of granulocytes less than 100 per μL for more than 3 days
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development of febrile neutropenia
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the platelet count is less than 25,000 per μL
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delay of the next cycle of chemotherapy for more than 1 week due to toxicity
To detect non-hematologic toxicity, a regular examination of the patient and control 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 the clinical assessment of the doctor of the dynamics of toxic manifestations. Special patient groups
Elderly patients: evidence that suggests that elderly patients need to adjust the dose is not available, although the clearance of gemcitabine decreases with age, and the half-life increases.
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 of preparation of infusion solution.
As a solvent, only 0.9% solution of sodium chloride is used (no preservatives).
To prepare a solution for infusion, the contents of the 200 mg bottle are dissolved in at least 5 ml, and 1000 mg - in at least 25 ml of a 0.9% solution of sodium chloride for injection. The bottle is gently shaken until the lyophilizate is completely dissolved. The prepared drug solution should be clear.
The maximum concentration of gemcitabine should not exceed 40 mg / ml. When preparing solutions with concentrations above 40 mg / ml, incomplete dissolution of the drug may be observed.
A prepared solution of the Gemcitar® preparation,containing the desired dose of the drug before dilution with a sufficient amount of 0.9% solution of sodium chloride for injection for a 30-minute intravenous infusion.
Before parenteral administration, visual inspection of the prepared infusion solution is necessary for the presence of mechanical impurities and discoloration.