When choosing a dose and a mode of administration, Docethers in each individual case should refer to the special literature.
Intravenously, by slow infusion (for 1 h), at a dose of 60-100 mg / m2 body surface, every 3 weeks.
To prevent reactions of hypersensitivity,and to reduce fluid retention for all patients (excluding prostate cancer patients) prior to the administration of the drug, premedication with glucocorticosteroids is carried out, for example, dexamethasone inside at a dose of 16 mg / day (8 mg twice daily), for 3 days, starting 1 day before docetaxel administration.
Patients with prostate cancer receiving concomitant treatment with prednisone or prednisolone are premedicated with dexamethasone at a dose of 8 mg for 12, 3 and 1 hour before the onset of docetaxel administration.
To reduce the risk of development of hematological complications, preventive administration of granulocyte colony-stimulating factor (G-CSF) is recommended.
Mammary cancer
Recommended dose Doceters 60-100 mg / m2 every 3 weeks.
With adjuvant therapy patients with an operable form of breast cancer, the Docetera preparation is administered at a dose of 75 mg / m2 1 hour after administration of doxorubicin (50 mg / m2) and cyclophosphamide (500 mg / m2) every 3 weeks. A total of 6 cycles.
As a monotherapy the drug is given in a dose of 100 mg / m2 every 3 weeks.
When combined with doxorubicin (50 mg / m2) or capecitabine (1250 mg / m2 inside 2 times a day for 2 weeks with a subsequent weekly break) Docerera is administered at a dose of 75 mg / m2 every 3 weeks.
In the case of trastuzumab the recommended dose of Docetera is 100 mg / m2 every 3 weeks. To clarify the dose and method of administration of trastuzumab, see the instructions for the medical use of trastuzumab.
Non-small cell lung cancer
Docetera is administered both with monotherapy and in combination with platinum preparations at a dose of 75 mg / m2 every 3 weeks.
Metastatic ovarian cancer
Docetera is administered at a dose of 100 mg / m2 every 3 weeks.
Inoperable, locally advanced squamous cell carcinoma of the head and neck
Docter is administered at a dose of 75 mg / m2. After infusion, Doctors on the same day undergo infusion of cisplatin at a dose of 75 mg / m2 for 1 hour, followed by infusion of fluorouracil in a dose 750 mg / m2/ day in the form of a 24-hour infusion for 5 days. This mode is prescribed 1 time in 3 weeks and repeated up to 4 cycles. After the course of chemotherapy, radiotherapy is prescribed.
Metastatic squamous cell carcinoma of the head and neck
Docter is administered in a dose of 100 mg / m2 every 3 weeks.
Metastatic hormone-resistant prostate cancer
Docter is administered at a dose of 75 mg / m2 1 time in 3 weeks. Prednisone or prednisolone prescribe inside 5 mg twice a day for a period of the entire course of treatment with the drug.
Metastatic stomach cancer, including the cardiac department
Docter is administered at a dose of 75 mg / m2 1 time in 3 weeks. After infusion of Doceter's preparation on the same day, an infusion of cisplatin in a dose of 75 mg / m2 for 1-3 h, followed by infusion of fluorouracil at a dose of 750 mg / m2/ day in the form of a 24-hour infusion for 5 days, starting from the end of the infusion of cisaplastin.
Correction of dose
Docetera is administered at a neutrophil count of> 1500 / μl. With a decrease in the number of neutrophils <500 / μl, which was observed for more than a week, or development of febrile neutropenia, or development of severe skin reactions, or severe peripheral neuropathy during docetaxel therapy, the dose for the following administration should be reduced from 100 to 75 mg / m2 and / or from 75 to 60 mg / m2. If similar complications occur when using Docetera in a dose of 60 mg / m2 treatment should be discontinued.
With combined therapy of breast cancer
Patients with an operable form of breast cancer who receive adjuvant therapy, in the case of febrile neutropenia, should receive G-CSF during all subsequent cycles. With the preservation of febrile neutropenia, it is necessary to reduce the dose of the drug.
Docerera up to 60 mg / m2 and continue to receive G-CSF. If G-CSF is not used, the dosage of Docetera should be reduced from 75 mg / m2 up to 60 mg / m2. For patients with grade 3 and 4 stomatitis (WHO classification of toxicity of antitumor chemotherapy), a dose reduction of 60 mg / m2.
With the combined use of Docetera and capecitabine at the first occurrence of toxicity of the 2nd degree, remaining until the beginning of the next cycle of therapy with Docetera / capecitabine preparations, treatment can be postponed until the toxicity level drops to 0-1, while the next cycle of treatment introduces 100% of the initial dose of Docetera. In the case of second-degree toxicity or the first episode of grade 3 toxicity at any time of the treatment cycle, treatment is delayed until the toxicity level drops to 0-1 degree, then treatment with Docetera is resumed at a dose of 55 mg / m2.
With any subsequent manifestations of toxicity or the appearance of any type of toxicity of the 4th degree, the administration of Docecer should be discontinued.
Correction of doses of capecitabine should be carried out in accordance with its instruction for medical use.
With the combined treatment of non-small cell lung cancer
The dose of Docetera in the next cycle should be reduced to 65 mg / m2 for patients who initially receive a Docter at a dose of 75 mg / m2 in combination with cisplatin or carboplatin, in which the number of platelets in the previous cycle of treatment decreased to <25,000 / μl (with cisplatin) and to <75,000 / μl (with carboplatin), or patients with advanced febrile neutropenia, or in patients with severe manifestations of nonhematological toxicity. Recommendations for correcting the dose of cisplatin in its instructions for medical use.
When a combination of Docetera with cisplatin and fluorouracil in the case of febrile neutropenia or infection, despite the administration of G-CSF, the dosage of Docetera should be reduced to 60 mg / m2. With the subsequent development of episodes of complicated neutropenia, it is recommended to reduce the dose of Docetera with 60 mg / m2 up to 45 mg / m2. If thrombocytopenia develops 4 degrees, then the dose of Docezer should be reduced from 75 mg / m2 up to 60 mg / m2. Subsequent resumption of cycles of Docetera is possible with a neutrophil count> 1500 / μL and platelets> 100,000 / μL; If toxicity persists, treatment should be discontinued.
With the development of other types of toxicity, the dosage adjustment of the Docetera preparation is carried out in accordance with the following recommendations, given in the table:
| Toxicity | Correction of dose |
| Diarrhea 3 degrees | The first episode: reduce the dose of fluorouracil by 20%. Repeated episode: reduce the dose by 20%. |
| Diarrhea 4 degrees | The first episode: reduce the dose of fluorouracil and on 20%. Repeat episode: stop treatment. |
| Stomatitis 3 degrees | The first episode: reduce the dose of fluorouracil by 20%. Repeat episode: undo fluorouracil at subsequent cycles. The third episode: reduce the dose by 20%. |
| Stomatitis 4 degrees | The first episode: fluorouracil at subsequent cycles. Repeated episode: reduce the dose by 20%. |
For recommendations on correcting the dose of cisplatin, see its instructions for medical use.
Special groups of patients
Patients with impaired liver function
In patients with the level of transaminases in the blood plasma (ALT and / or ACT), more than 1.5 times the upper limit of normal (VGN), and / or alkaline phosphatase, which exceeds more than 2.5 times the IGN, the recommended dose of Docetera is 75 mg / m2. In patients with increased bilirubin concentration and / or increased ALT activity and ACT (> 3.5 UGN) in combination with an increase in alkaline phosphatase activity more than 6 times that of UHN, do not use Docter.
Data on the use of docetaxel in combination with other drugs in patients with impaired hepatic function are not currently available.
Children
The safety and efficacy of docetaxel in children have not been adequately studied, and there is limited experience in children.
Aged people
There are no specific recommendations for the use of docetaxel in the elderly.
When combined with capecitabine in patients older than 60 years, a reduction in the initial dose of capecitabine is recommended (see the instructions for the medical use of capecitabine).
Instructions for preparing a solution for intravenous administration
a) Preparation of the premixed solution
Before reconstitution, the bottles with the preparation and the solvent should be kept at room temperature for 5 minutes.
All contents of the vial with the solvent are added to the vial with the concentrate.
The vial with the resulting mixture is stirred, gently shaking it for 45 seconds (do not shake!) And left for 5 minutes at room temperature, after which the solution is checked for homogeneity and transparency (the presence of foam even after 5 minutes is the norm).
The pre-mixed solution should be used to prepare the infusion solution immediately.
b) Preparation of a solution for infusion
The required volume of the premixed solution containing 10 mg / ml of docetaxel, according to the required dose, is diluted with 5% dextrose solution or 0.9% sodium chloride solution to a concentration of not more than 0.74 mg / ml. The resulting infusion solution should be mixed. The resulting solution should be used within 4 hours.
Solution for infusion before administration should be examined, in the presence of sediment, the solution should be destroyed.
The pre-mixed docetaxel solution should be used immediately after preparation, and the infusion solution should be used within 4 hours (including one hour infusion) at room temperature and normal light conditions.