The preparation Gikamtin, lyophilizate for the preparation of a solution for infusions, must first be reconstituted before use and then prepared (see the instructions for preparing the solution).
Before the first course of therapy with Gikamtin the initial number of neutrophils of patients should be ≥ 1.5 x 109/ l, platelets ≥100 х 109/ l and concentration hemoglobin - ≥9 g / dl (after transfusion if necessary).
Adult patients and elderly patients
Small cell lung cancer. Cancer of the ovary
Therapy with Gikamtin is carried out daily for five days in the form of an intravenous infusion lasting about 30 minutes. The interval between the courses is three weeks.
To achieve the effect, it is recommended to conduct a minimum of four courses of therapy (in clinical studies, the mean time of onset of the effect in patients with ovarian cancer was 7.6-11.7 weeks, in patients with small cell lung cancer - 6.1 weeks. In clinical practice, in 18% of patients with ovarian cancer the effect was achieved after five or more courses of therapy).
Initial dose
The recommended daily dose of the drug Gycamtin is 1.5 mg / m2 for five consecutive days at intervals of 21 days.
Subsequent doses
Therapy with Gikamtin should be performed only with the following blood parameters in the patient: the number of neutrophils ≥1 x 109/ l, platelets - ≥ 100 x 109/ l and concentration hemoglobin - ≥9 g / dl (after transfusion if necessary). According to standards accepted in oncological practice, management of patients with neutropenia suggests either the use of topotecan with other drugs (eg, granulocyte colony stimulating factor (G-CSF)) or a reduction in the dose of topotecan to maintain an acceptable level of neutrophils. In the case of a decision on the need to reduce the dose of the drug Gikamtin in patients with severe neutropenia (the number of neutrophils less than 0.5 x 109/l) for seven or more days, or febrile neutropenia, or in the event of postponement of treatment due to neutropenia, the dose should be reduced by 0.25 mg / m2 per day up to 1.25 mg / m2 per day (hereinafter - up to 1.0 mg / m2 per day, if necessary). Similarly, the dose of the drug should be reduced with a decrease in the number of platelets less than 25 x 109/ l.
In clinical studies, topotecan therapy was discontinued if required lower the dose below 1.0 mg / m2.
Cervical cancer
Initial dose
The recommended daily dose of Gikamtin is 0.75 mg / m2 in the form of a 30-minute intravenous infusion daily in the 1st, 2nd and 3rd days of the course. On the 1st day of therapy after administration of the drug Gikamtin, infusion of cisplatin in a dose of 50 mg / m2. The intervals between the courses are 21 days. Therapy is carried out for 6 courses or until signs of disease progression appear. Subsequent doses
Therapy with Gikamtin should be performed only with the following indices: the number of neutrophils ≥ 1.5 x 109/ l, platelets - ≥ 100 x 109/ l and the concentration of hemoglobin - ≥9 g / dl (after transfusion if necessary). According to standards accepted in oncological practice, management of patients with neutropenia suggests either the use of topotecan with other drugs (eg, G-CSF), or a reduction in the dose of topotecan to maintain an acceptable level of neutrophils.
If a decision is made to reduce the dose of Gikamtin in patients from severe neutropenia (neutrophil count less than 0.5 x 109/ l) for seven or more days, or febrile neutropenia, or in the event of delayed treatment due to neutropenia, dose should be reduced by 20% to 0.6 mg / m2 at day (hereinafter - up to 0.45 mg / m2 per day). Similarly, the dose of the drug should be reduced with a decrease in the number of platelets less than 25 x 109/ l.
Special patient groups
Children
Use of the drug Gikamtin for the treatment of children is not recommended, since the experience of using the drug in children is not enough.
Elderly patients
Differences in the effectiveness of the drug in patients over the age of 65 and in younger patients were not noted.
Patients with impaired renal function
Monotherapy
Featured Daily doses for patients with creatinine clearance:
- from 20 to 39 ml / min - 0.75 mg / m2 in a day;
- >40 ml / min - correction of the dosing regimen is not required;
- <20 ml / min - no recommendations.
Recommendations for the dosing regimen in patients with creatinine clearance from 20 to 39 ml / min are based on studies that included patients with widespread tumors process.
Combination Therapy
Initiate therapy with Gikamtin in combination with cisplatin for the treatment of cervical cancer is recommended only for patients who have a plasma creatinine concentration of less than 1.5 mg / dl. If, during treatment, the creatinine concentration in the blood plasma exceeds 1.5 mg / dl, the recommendations for cisplatin should be followed to reduce its dose or to abolish. In the case of cisplatin abolition, there is insufficient data concerning the continuation of monotherapy with Gikamtin in patients with cervical cancer.
Patients with impaired hepatic function
Monotherapy
For patients with impaired hepatic function (serum concentration bilirubin from 1.5 to 10 mg / dL) dose adjustment is not required.
Patients with impaired liver function could tolerate a dose of 1.5 mg / m for five days every three weeks, although there was a slight decrease in clearance of topotecan.
Combination Therapy
When administering topotecan with other cytotoxic drugs, it may be necessary to adjust its dose.
Instructions for preparing a solution
The content of the vial is dissolved in 4 ml of sterile water for injection to a concentration of 1 mg / ml (reconstituted solution).The reconstituted solution must be diluted with 0.9% sodium chloride solution (infusion solution) or 5% dextrose solution (infusion solution) to a concentration of 25-50 μg / ml (prepared solution). The reconstituted solution should be used immediately after preparation or stored in the refrigerator at a temperature of 2-8 ° C for 24 hours.
The prepared solution should be used immediately after preparation or stored in a refrigerator at a temperature of 2-8 ° C in within 24 hours.