Composition, form of production and packaging
Concentrate for the preparation of a solution for infusions in the form of a transparent, oily solution from yellow to brownish-yellow color; The applied solvent is clear, colorless.
0.5 ml
docetaxel (in the form of docetaxel trihydrate) 20 mg
[PRING] polysorbate 80 - up to 0.5 ml.
Solvent: (13% of ethanol in water d / v) ethanol 95% (V / V) - 191.1 mg, water d / and - up to 1.5 ml.
0.61 ml - bottles of colorless glass (1) complete with a solvent (1.98 ml 1 pack) - packings of cellular contour (1) - packs of cardboard.
Concentrate for the preparation of a solution for infusions in the form of a transparent, oily solution from yellow to brownish-yellow color; The applied solvent is clear, colorless.
2 ml
docetaxel (in the form of docetaxel trihydrate) 80 mg
[PRING] polysorbate 80 - up to 2.0 ml.
Solvent: (13% of the ethanol solution in water) ethanol 95% (V / V) - 764.4 mg, water d / and - up to 6.0 ml.
2.36 ml - bottles of colorless glass (1) complete with a solvent (fl. 7.33 ml 1 pc.) - packings of cellular contour (1) - packs of cardboard.
Concentrate for the preparation of solution for infusions in the form of a clear solution from light yellow to brownish-yellow color.
8 ml
docetaxel (in the form of docetaxel trihydrate) 160 mg
[PRING] polysorbate 80 - 4.32 g, ethanol anhydrous - 3.16 g.
8 ml - vials of colorless glass (1) - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
An antitumor drug of plant origin (from the taxoid group). Accumulates tubulin in microtubules, prevents their disintegration, which disrupts the process of dividing the tumor cells. Docetaxel is stored for a long time in cells, where its concentration reaches high values. In addition, docetaxel is active against some, though not all, cells that produce in excess P-glycoprotein (P-gP), encoded by the multiple resistance gene to chemotherapeutic drugs.
In vivo docetaxel has a broad spectrum of activity against tumors of mice and transplanted human tumor cells.
The efficacy of docetaxel has been proven in breast cancer, non-small cell lung cancer, ovarian cancer, hormone-resistant prostate cancer, stomach cancer, head and neck cancer.
PHARMACOKINETICS
Distribution
The pharmacokinetics of docetaxel is dose-dependent and corresponds to a three-phase pharmacokinetic model with T 1/2 in the?,?, And? -phases - 4 min, 36 min and 11.1 h respectively.
After a one-hour infusion of docetaxel at a dose of 100 mg / m, the average C max of docetaxel in plasma was 3.7 Ојg / ml with a corresponding AUC value of 4.6 Ојg / hr / ml. The average value of V d in the equilibrium state is 113 liters.
The binding of docetaxel to plasma proteins is more than 95%.
Metabolism and excretion
The average value of the total clearance in the equilibrium state is 21 l / h / m. The values ​​of total clearance of docetaxel in different patients differed by approximately 50%.
Docetaxel after oxidation of the tert-butyl ether group with the participation of isoenzymes of the P450 system is excreted by the kidneys for 7 days, with urine (6% of the administered dose) and through the gastrointestinal tract, with feces (75% of the administered dose). About 80% of the administered dose of docetaxel is excreted for 48 hours with feces in the form of metabolites (the main inactive metabolite and three less significant inactive metabolites) and in a very small amount - unchanged.
Pharmacokinetics in special clinical cases
The pharmacokinetics of docetaxel does not depend on the age and sex of the patient.
In case of mild violations of liver function (ALT and ACT activity not more than 1.5 of their VGN in combination with AC activity of not more than 2.5 VGN), the total clearance of docetaxel is reduced by an average of 27%.
With mild or moderate fluid retention, clearance of docetaxel does not change; there is no information on its clearance with a pronounced fluid retention.
In combined use, docetaxel does not affect the clearance of doxorubicin and the plasma concentration of doxorubicinol (doxorubicin metabolite).
The pharmacokinetic parameters of docetaxel, doxorubicin and cyclophosphamide did not change with their simultaneous application.
Capecitabine does not affect the pharmacokinetics of docetaxel ( Cmax , AUC), and docetaxel, in turn, does not affect the pharmacokinetics of capecitabine and the most important metabolite of capecitabine (5'-DFUR).
The clearance of docetaxel in combination therapy with cisplatin does not change compared to its clearance in monotherapy. The pharmacokinetic profile of cisplatin administered shortly after infusion of docetaxel did not differ from that of single cisplatin.
Prednisone does not affect the pharmacokinetics of docetaxel administered after standard premedication with dexamethasone.
Combination therapy with docetaxel, cisplatin and fluorouracil does not change their pharmacokinetic parameters.
In children, pharmacokinetic parameters in monotherapy with docetaxel and docetaxel in combination with cisplatin and fluorouracil were similar to those in adults.
INDICATIONS
Operational breast cancer of breast cancer (Taxotere В® in combination with doxorubicin and cyclophosphamide, adjuvant chemotherapy):
- operable breast cancer with involvement of regional lymph nodes;
- operable breast cancer without involvement of regional lymph nodes in patients who undergo chemotherapy according to established international screening criteria for primary chemotherapy of early breast cancer (with one or more factors of high recurrence risk: tumor size greater than 2 cm, negative status of estrogen and progesterone receptors, high histological / nuclear grade of tumor malignancy (grade 2-3), age less than 35 years).
Metastatic and / or topically advanced breast cancer:
- locally advanced or metastatic breast cancer (Taxotere В® in combination with doxorubicin, 1st line therapy);
- metastatic breast cancer with tumor overexpression of HER2 (Taxotere В® in combination with trastuzumab, 1st line therapy);
- locally advanced or metastatic breast cancer with ineffectiveness of previous chemotherapy involving anthracyclines or alkylating agents (Taxotere В® as monotherapy) or with ineffectiveness of previous chemotherapy involving anthracyclines (Taxotere В® in combination with capcatabine).
Non-small cell lung cancer:
- locally advanced or metastatic non-small cell lung cancer with ineffectiveness of previous chemotherapy (Taxotere В® as monotherapy);
- unresectable locally advanced or metastatic non-small cell lung cancer (Taxotere В® in combination with cisplatin, 1st line therapy).
Ovarian Cancer:
- metastatic ovarian cancer with ineffectiveness of previous therapy of the 1st line (Taxotere В® as a monotherapy, 2nd line therapy).
Prostate cancer:
- Metastatic hormone-resistant (androgen-independent) prostate cancer (Taxotere В® in combination with prednisone or prednisolone).
Stomach cancer:
- Metastatic stomach cancer, including cancer of the esophageal-gastric junction (Taxotere В® in combination with cisplatin and fluorouracil, 1st line therapy).
Head and neck cancer:
- locally advanced squamous cell carcinoma of the head and neck (Taxotere В® in combination with cisplatin and fluorouracil, induction therapy).
DOSING MODE
Treatment with Taxotere В® should be done only under the supervision of a doctor who has experience in carrying out anti-tumor chemotherapy in a specialized hospital.
To prevent hypersensitivity reactions, and to reduce fluid retention for all patients (excluding prostate cancer patients) prior to the administration of Taxotere В® , premedication of GCS is performed, for example, dexamethasone at a dose of 16 mg / day (8 mg 2 times / day) inside, within 3 days, starting 1 day before the administration of Taxotere В® .
In patients with prostate cancer receiving concomitant treatment with prednisone or prednisolone, dexamethasone is premedicated at a dose of 8 mg for 12, 3 and 1 h before the administration of Taxotere В® .
To reduce the risk of development of hematological complications, preventive administration of G-CSF is recommended.
Taxotere В® is injected / drip for 1 hour 1 time per 3 weeks.
Mammary cancer
In adjuvant therapy for operable breast cancer with regional lymph nodes and operable breast cancer without regional lymph nodes, the recommended dose of Taxotere В® is 75 mg / m 2 1 h after administration of doxorubicin (50 mg / m 2 ) and cyclophosphamide (500 mg / m 2 ) every 3 weeks (TAC scheme). Only 6 cycles.
In locally advanced or metastatic breast cancer, as a first-line therapy, docetaxel 75 mg / m 2 is administered in combination with doxorubicin 50 mg / m 2 ; as a 2-line therapy, the recommended dose of docetaxel for monotherapy is 100 mg / m 2 .
With the combination of Taxotere В® plus trastuzumab, the recommended dose of Taxotere В® is 100 mg / m 2 every 3 weeks with weekly administration of trastuzumab. The initial infusion of docetaxel is performed the day after the first dose of trastuzumab. Subsequent doses of docetaxel are administered immediately after the end of the infusion of trastuzumab (with good tolerability of the previous dose of trastuzumab). Doses and methods for the administration of trastuzumab are indicated in the instructions for the medical use of trastuzumab.
When combined with capecitabine, the recommended dose of docetaxel is 75 mg / m 2 every 3 weeks, and capecitabine - 1250 mg / m2 2 times per day (within 30 minutes after meals) for 2 weeks followed by a one-week rest period. To calculate the dose of capecitabine in accordance with the surface area of ​​the body, see the instructions for the medical use of capecitabine.
Non-small cell lung cancer
In patients who have not received previous chemotherapy , the following treatment regimen is recommended: docetaxel 75 mg / m 2 , immediately afterwards, cisplatin administration at a dose of 75 mg / m 2 for 30-60 min.
For treatment after the ineffectiveness of chemotherapy on the basis of platinum preparations , monotherapy with docetaxel at a dose of 75 mg / m 2 is recommended.
Metastatic ovarian cancer
For therapy of the second line of ovarian cancer, Taxotere В® is recommended to be used as a monotherapy in a dose of 100 mg / m 2 every 3 weeks.
Prostate Cancer
The recommended dose of Taxotere В® is 75 mg / m 2 once every 3 weeks. Prednisone or prednisolone is prescribed continuously for 5 mg orally 2 times / day.
Stomach cancer
The recommended dose of Taxotere В® is 75 mg / m 2 as a one-hour infusion followed by cisplatin infusion at a dose of 75 mg / m 2 for 1-3 hours (both drugs only on the first day of each chemotherapy cycle). After cisplatin is administered, a 24-hour infusion of fluorouracil at a dose of 750 mg / m 2 / day for 5 days is performed.Treatment is repeated every 3 weeks. Premedication should be done with antiemetic drugs and appropriate hydration for the administration of cisplatin. To reduce the risk of hematologic toxicity, the introduction of G-CSF is indicated for prophylactic purposes.
Head and neck cancer
Premedication should be performed with antiemetics, as well as appropriate hydration (before and after cisplatin administration). It is necessary to prevent the development of neutropenic infections. All patients receiving treatment regimens containing Taxotere В® were given antibiotics prophylactically.
Induction chemotherapy followed by radiotherapy. For induction therapy for locally advanced inoperable squamous cell carcinoma of the head and neck, therecommended dose of TaxotereВ® is 75 mg / m 2 in the form of a one-hour intravenous infusion followed by cisplatin at a dose of 75 mg / m 2 for 1 hour (both drugs are administered only on the first day of each cycle of chemotherapy). After this, a continuous infusion of fluorouracil in a dose of 750 mg / m 2 / day for 5 days. This pattern is repeated every 3 weeks for 4 cycles. After chemotherapy, patients should receive radiation therapy.
Induction chemotherapy followed by chemoradiotherapy. For induction therapy of locally advanced squamous cell carcinoma of the head and neck (technically unresectable, with low probability of surgical cure or in organ preservation), the recommended dose of Taxotere В® is 75 mg / m 2 as a one-hour intravenous infusion followed by a 0.5-3- hour infusion of cisplatin in a dose of 100 mg / m 2 (both drugs are administered only on the first day of each cycle of chemotherapy) and followed by continuous infusion of fluorouracil at a dose of 1000 mg / m 2 / day from 1 to 4 days. This treatment regimen is repeated every 3 weeks, only 3 cycles.After chemotherapy, patients should receive chemoradiotherapy. For information on correcting doses of cisplatin and fluorouracil, instructions for the use of these drugs should be used.
Correction of dose
General principles
Taxotere ® should be administered with a neutrophil count in the peripheral blood of ≤ 1500 / μL. In the case of febrile neutropenia, the number of neutrophils <500 / μl lasting more than one week, expressed or cumulative (intensifying with repeated administration) skin reactions, or severe peripheral neuropathy with docetaxel therapy, its dose in the following administrations should be reduced from 100 mg / m 2 to 75 mg / m 2 and / or from 75 mg / m 2 to 60 mg / m 2 . If such reactions persist and with a dose of docetaxel 60 mg / m 2 , treatment with the drug should be discontinued.
Adjuvant treatment of breast cancer
Patients with breast cancer who receive adjuvant therapy with Taxotere В® in combination with doxorubicin and cyclophosphamide (TAC regimen), the introduction of G-CSF is recommended for primary prevention. Patients who underwent febrile neutropenia or neutropenic infection in all subsequent cycles should reduce the dose of Taxotere В® to 60 mg / m 2 . In patients who developed stomatitis of 3 or 4 degrees of severity, it is necessary to reduce the dose of docetaxel to 60 mg / m 2 .
Taxotere В® in combination with cisplatin
Patients who initially received docetaxel at a dose of 75 mg / m 2 in combination with cisplatin and whose platelet count in the previous cycle decreased to 25,000 / ОјL, or in patients who developed febrile neutropenia, or in patients with severe non-hematologic toxicity , the dose of docetaxel in subsequent cycles should be reduced to 65 mg / m 2 .
To correct the dose of cisplatin should use the instruction for medical use of cisplatin.
Taxotere В® in combination with capecitabine
To correct the dose of capecitabine when combined with Taxotere В® , instruction should be used for the medical use of capecitabine.
At the first appearance of toxicity of 2 degrees of severity, which is maintained at the beginning of the next cycle of Taxotere В® / capecitabine, the next treatment cycle can be postponed until the toxicity decreases to 0-1 severity, and 100% of the initial dose is administered during the next treatment cycle.
In patients with a second occurrence of grade 2 toxicity or the first development of grade 3 toxicity at any time of the cycle, treatment is postponed until toxicity is reduced to 0-1 severity, then treatment with TaxotereВ® is resumed at a dose of 55 mg / m 2 .
For any subsequent occurrence of toxicity or the appearance of any toxicity of 4 degrees of severity, administration of TaxotereВ® should be discontinued.
Taxotere В® in combination with trastuzumab
To correct the dose of trastuzumab, you should use the instructions for the medical use of trastuzumab.
Taxotere В® in combination with cisplatin and fluorouracil
Patients receiving Taxotere В® in combination with cisplatin and fluorouracil should, in accordance with existing generally accepted recommendations, receive antiemetic drugs and sufficient hydration. To reduce the risk of complicated neutropenia, G-CSF should be used.
If, despite the use of G-CSF, febrile neutropenia, prolonged neutropenia or neutropenic infection occurs, the dose of Taxotere В® should be reduced from 75 to 60 mg / m 2 . In the subsequent development of episodes of complicated neutropenia, it is recommended to reduce the dose of Taxotere В® from 60 mg / m 2 to 45 mg / m 2 .With the development of thrombocytopenia of 4 degrees of severity, the dose of Taxotere В® is recommended to be reduced from 75 mg / m 2 to 60 mg / m 2.Subsequent cycles with docetaxel are possible with neutrophil count> 1500 / ОјL and platelets> 100,000 / ОјL. With persistent retention of these toxic manifestations, treatment should be discontinued.
The recommended dose adjustment for toxic development in patients receiving Taxotere В® in combination with cisplatin and fluorouracil (FU)
Toxicity Correction of dose
Diarrhea 3 degrees of severity First episode: reduce the dose of FU by 20% Repeat episode: reduce the dose of Taxotere В® by 20%
Diarrhea 4 degrees of severity First episode: reduce the dose of Taxotere В® and FU by 20% Repeat episode: stop treatment
Stomatitis / mucositis Grade 3 first episode: reduce the dose FU 20% Re episode to terminate only the application FU in all subsequent cycles third episode: reduce the dose of Taxotere В® 20%
stomatitis / mucositis 4 severity first episode to terminate only the application FU in all subsequent cycles repeated episode reduce drug dose Taxotere В® in 20%
use appropriate for medical use instructions for advice on correcting doses of cisplatin and fluorouracil.
When non-small cell carcinoma of the head and neck in patients who develop complicated neutropenia (including prolonged neutropenia, febrile neutropenia or infection), it is recommended the use of G-CSF (eg, 1 to 15 days) in all subsequent cycles as a prophylactic measure.
Special patient groups
Children. The safety and efficacy of the drug Taxotere В® in children has been insufficiently studied. There is limited experience with the drug Taxotere В® in children. Is not established efficacy and safety of the drug Taxotere В® in cancer of the nasopharynx in children and adolescents from 1 month to 18 years. Taxotere В®Do not use in children under indications breast cancer, non-small cell lung cancer, prostate cancer, stomach cancer and cancer of the head and neck, except for undifferentiated nasopharyngeal carcinoma (type I and II).
Elderly patients. Based on data from population pharmacokinetic analysis, there are no special instructions for use of the drug Taxotere В® in elderly patients. Inpatients aged 60 years and older with the drug combinations of Taxotere В® with capecitabine recommended dose of capecitabine decrease by 25% (in accordance with instruction for medical use capecitabine).
Patients with hepatic insufficiency.Based on the pharmacokinetic data obtained for TaxotereВ® preparation В® monotherapy at 100 mg / m 2 in patients with ALT activity and / or ACT> 1.5 ULN or activity of ALP> 2.5 ULN, the recommended dose of Taxotere drug В® is 75 mg / m 2 . Patients with increased content of bilirubin in the blood (> 1 ULN) and / or with increased ALT activity and ACT (> 3.5 ULN) in combination with increased activity of alkaline phosphatase (> 6 ULN) may not be recommended dose reduction, and should not be without strict indications apply docetaxel.
Combination drug Taxotere В®with cisplatin and fluorouracil for the treatment of gastric cancer has not been used in patients with elevated ALT and / or ACT (> 1.5 ULN) in combination with an increase in alkaline phosphatase activity (> 2.5 ULN) and elevated levels of bilirubin in the blood (> 1 ULN); in these patients it can not be recommended and a dose reduction should not be used without strict indications docetaxel.
Currently, there are no data regarding the use of the drug Taxotere В® in combination with other medications in patients with impaired liver function.
Patients with impaired renal function. There are no data on the use of docetaxel in patients with severe renal impairment.
Preparation of the solution for infusion
Do not use Taxotere В®For the preparation of infusion solution concentrate (20 mg / 1 ml, 80 mg / 4 ml and 160 mg / 8 mL) containing in one vial and concentrate the solvent, together with the forms of manufacture Taxotere drug В® 2 vials (concentrate and solvent).
Taxotere В® , concentrate to prepare an infusion solution (20 mg / 1 ml, 80 mg / 4 ml and 160 mg / 8 mL) containing in one vial and concentrate the solvent, it does not require pre-dilution solvent and is ready to add to the infusion solution .
Each vial is designed for single use and should be used immediately.
If the vials are stored in refrigerator, the required number of packages drug Taxotere В®the concentrate for solution for infusion should be kept at room temperature (no higher than 25 В° C) for 5 minutes prior to its use for the preparation of an infusion solution.
The required amount of concentrate for the preparation of an infusion solution Taxotere В®20 mg / 1 ml, according to the desired dose aseptically removed from the flasks using a graduated syringe connected to 21G gauge needle and injected into the bag for infusion or bottle containing 250 ml of 5% dextrose or 0.9% sodium chloride chloride (conducted by administering a single injection into the infusion container with all necessary dose). If the required dose exceeds 190 mg docetaxel, use containers for infusions larger volume that the concentration of docetaxel was not higher than 0.74 mg / ml.
The contents of the bag should be mixed by inverting their slow infusion or vial. Infusion of the resulting solution should be carried out within 6 hours after preparation (including 1 hour of administration) when stored at room temperature and normal lighting conditions. After preparation of infusion solution aseptically demonstrated its physical and chemical stability during the 48 hours when stored at a temperature of from 2 В° to 8 В° C in the vessel is not made of PVC.
Concentrate for solution for infusion Taxotere В® 20 mg / 1 ml, 80 mg / 4 ml and 160 mg / 8 ml, and the solution for infusions, as well as any other formulations for parenteral administration must be inspected before administration: the precipitate having them enter and can not be disposed of.
Residues drug and all materials used for its dilution and administration must be disposed of in accordance with standard regulations.
SIDE EFFECT
Determining the frequency of adverse reactions (according to WHO classification): very common (10%?), Often (1% and <10%, uncommon (0.1% and <1%), rarely (0.01% and <0.1%)??? very rare (<0.01%), the unknown frequency (when the available data it is not possible to assess the incidence of adverse events).
monotherapy drug Taxotere В® (75 mg / m 2 and 100 mg / m 2 )
From the hematopoietic system:very often - reversible and non-cumulative (not aggravated by repeated administration) neutropenia, which was observed in 96.6% of patients who did not receive G-CSF (the number of neutrophils is reduced to a minimum on average 7 days, patients with intensive prior chemotherapy, this period may be shorter and the average duration of significant neutropenia <500 cells / well is 7 days), febrile neutropenia, infections; often - severe infections due to decreased number of neutrophils in peripheral blood of <500 / ul, serious infections including sepsis and pneumonia (including fatal), thrombocytopenia <100,000 / microliter, bleeding due to thrombocytopenia, <50,000 / ul, anemia (hemoglobin <11 g / dl), including: severe anemia (hemoglobin <8 g / dL); rarely - severe thrombocytopenia.
Allergic reactions:very often - flushing of the skin; rash together with itching and without it; chest tightness; backache; dyspnea; drug fever or chills (usually occur within a few minutes after the start of the infusion of the drug Taxotere В® and are easy to moderate); often - severe allergic reactions, characterized by a decrease in blood pressure and / or bronchospasm, generalized rash / erythema (disappear after cessation of infusion therapy and the appropriate destination).
Skin and subcutaneous tissue disorders:very often - localized eruptions mainly on the hands and feet, as well as on the face and chest, often accompanied by itching (these reactions are usually mild or moderately expressed, generally occurred within one week after the docetaxel infusion), hypo- and hyperpigmentation nails, pain in the nails, onycholysis (nail loss on the part of the free edge of the nail), alopecia; often - severe skin reactions such as rash followed by desquamation, including severe injury syndrome palms and soles, which may require interruption or termination of treatment with docetaxel; rarely - severe alopecia. In some cases, an additional influence on the occurrence of these reactions has provided a combination of several factors, such as opportunistic infections, concomitant therapy, and the underlying disease.
From the digestive system: very often - nausea, vomiting, diarrhea, anorexia, stomatitis; often - severe nausea, severe vomiting, severe diarrhea, constipation, severe stomatitis, esophagitis, epigastric pain (including strong), gastrointestinal bleeding, increased ACT serum activity, ALT, alkaline phosphatase and bilirubin in the blood, more than 2.5 times exceeding the ULN; rarely - severe gastrointestinal bleeding, severe constipation, severe esophagitis.
From the nervous system:very often - light or moderately expressed neurosensory reactions, including paresthesia, dysesthesia, pain including burning sensation and neuromotor response is mainly manifested by muscle weakness, dysgeusia; often - severe neurosensory and neuromotor reactions (Grade 3-4); rarely - severe impairment of taste. Should conduct a correction mode in the event of these neurological symptoms. If neuropathy symptoms stubbornly persist, treatment should be discontinued. Mean time to permit spontaneous neurotoxic reactions was 81 days from their beginning (0 to 741 days).
Cardio-vascular system: often - irregular heartbeat, high or low blood pressure, bleeding; rarely - heart failure.
The respiratory system: very often - shortness of breath; often - severe shortness of breath.
On the part of the musculoskeletal system: very often - myalgia; often - arthralgia.
General reaction:very often - asthenia (including heavy asthenia), generalized and localized pain (including chest pain noncardia genesis), fluid retention (reported on the development of peripheral edema and body weight gain and less frequently when new effusion pleural and pericardial cavity, ascites). Peripheral edema usually started with lower limbs and could move to a generalized weight gain of 3 kg or more. Fluid retention is cumulative (increases with repeated administration of the drug). Fluid retention has not been accompanied by acute episodes of oliguria or lowering blood pressure. Often - pronounced generalized and localized pain (including chest pain noncardia genesis).
Severe fluid retention. In patients treated with docetaxel alone at a dose of 100 mg / m 2 , the median total dose to the treatment because of fluid retention was more than 1000 mg / m 2 , and the median time to reverse development of fluid retention - 16.4 weeks (from 0 to 42 weeks). Patients who received premedication observed delay start moderate or severe fluid retention (average total dose of docetaxel, where the observed water retention, formed during premedication 818.9 mg / m 2 , and without premedication - 489.7 mg / m 2 ) but in some cases, fluid retention has been developing during the early courses of therapy.
Local reactions:often - the reaction at the site of injection were observed usually mild and manifest as hyperpigmentation, inflammation, redness and dryness of the skin, phlebitis, hemorrhage from punctured vein or vein edema.
Taxotere В® in combination with other drugs
Taxotere В® in combination with doxorubicin
In applying the drug Taxotere В® in combination with doxorubicin as compared to a monotherapy drug Taxotere В®We observed with greater frequency following side reactions: neutropenia, including severe neutropenia; febrile neutropenia; Thrombocytopenia, including severe thrombocytopenia; anemia; infections, including serious infections; nausea; vomiting; Diarrhea, including severe diarrhea; constipation; disease, including severe stomatitis; heart failure; alopecia. But less frequently observed allergic reactions; skin reactions, including heavy; nail infections, including heavy; fluid retention, including heavy; anorexia, neurosensory and neuromotor reactions, including severe forms; hypotension; arrhythmias; increase in liver transaminases, alkaline phosphatase, bilirubin in the blood; myalgia; asthenia.
Taxotere В® in combination with doxorubicin and cyclophosphamide (TAC circuit)
In applying this scheme chemotherapy compared to a monotherapy drug Taxotere В® was observed lower frequency of the following side reactions: neutropenia, severe anemia, febrile neutropenia, infections, allergic reactions, peripheral edema, neurosensory, and neuromotor response, nail infections, diarrhea, arrhythmia. But there was a higher rate of development of the following reactions: non-severe anemia, thrombocytopenia, nausea, vomiting, stomatitis, taste disturbance, constipation, fatigue, arthralgia, alopecia. Further observed: colitis, enterocolitis, perforation of the large intestine without deaths (in 2 of 4 patients required discontinuation of therapy), acute myeloid leukemia, acute leukemia.
Prophylactic G-CSF reduced incidence of neutropenia (60%) and neutropenic infections 3-4 degrees.
Taxotere В® in combination with capecitabine
In applying the drug Taxotere В®in combination with capecitabine observed more frequent development of adverse reactions with the digestive system (stomatitis, diarrhea, vomiting, constipation, abdominal pain, disturbances of taste perception); arthralgia; severe thrombocytopenia, and anemia; hyperbilirubinemia; hand-foot syndrome (limb dermahemia - palms and soles - followed by desquamation and edema); but more rare development of severe neutropenia; alopecia; violations of the nails, including onycholysis; asthenia; myalgia; loss of appetite and anorexia. Additionally observed dyspepsia, dry mouth, sore throat, oral candidiasis, dermatitis, erythematous rash, nail changes color, pyrexia, pain in the limbs, pain, back pain, lethargy (sleepiness, lethargy, stupor), shortness of breath, cough, epistaxis, paraesthesia, dizziness, headache,peripheral neuropathy, dehydration, watery eyes, weight loss.
Compared with patients younger patients aged 60 years and older who received a combination of the drug Taxotere В® with capecitabine, most marked development of Grade 3-4 toxicity.
Taxotere В® in combination with trastuzumab
Patients treated with combination drug Taxotere В® with trastuzumab (compared to a monotherapy drug Taxotere В®) Often experience nausea, diarrhea, constipation, abdominal pain, taste disturbances, febrile neutropenia, arthralgia, anorexia, toxic effects 4 severity, cases of heart failure, especially in patients previously treated with anthracyclines in the adjuvant treatment, but rarely observed neutropenia Grade 3-4, asthenia, fatigue, alopecia, nail infections, skin rash, vomiting, stomatitis, and myalgia. Further observed: lacrimation, conjunctivitis, inflammation of the mucous membranes, nasopharyngitis, pain in the throat and larynx, nasal bleeding, runny nose, flu-like illness, cough, pyrexia, chills, pain, chest pain, pain in extremity, back pain, bone pain , lethargy (sleepiness, lethargy, stupor), insomnia, dyspnea, erythema, neuralgia, paresthesia, headache,hypoesthesia.
Compared with docetaxel monotherapy observed to increase the incidence of serious adverse reactions.
Combination drug Taxotere В® with cisplatin
In applying this scheme compared to chemotherapy monotera
