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1 tablet includes 500 mg of a kapetsitabin.
Tutabin is issued in the form of tablets in a film cover, on 120 or 1440 pieces in secondary packaging.
Pharmacodynamics and pharmacokinetics
Kapetsitabin is a peroral tsitostatik and treats derivatives of a ftorpirimidin of a carbamate. In tests of in vitro kapetsitabin had no cytotoxic effect, however in vivo activation of this substance occurs in tumoral fabrics where it, being initially transformed in 5-ftoruratsit (5-FU) and being exposed to the subsequent metabolism, has selective cytotoxic effect on tumoral fabrics. As allocation 5, under the influence of the thymidinephosphorylase representing an angiogenic tumoral factor is carried out directly in tumor fabrics, its system influence on healthy bodies and fabrics of a human body insignificantly.
Fermental consecutive transformation of a kapetsitabin in 5 brings results in noticeably more significant concentration of drug in the tumor in comparison with its content in healthy surrounding fabrics. Activity of enzyme the thymidinephosphorylase observed in colorectal primary tumor four times exceeds the traced intensity of its action in healthy adjacent fabrics.
At patients with cancer is ovaries, a stomach, a mammary gland, a neck of uterus and a colorectal cancer, in tumor cells, in comparison with healthy fabrics, found higher levels of thymidinephosphorylase which transforms 5 -dezoksi-5-ftoruridin (5 -DFUR) in 5-FU. A further metabolism 5-FU as in tumoral, and healthy cells of a human body, passes with formation of metabolites – 5-ftoruridin triphosphate (FUTF) and 5-fluorine-2-dezoksiuridin of monophosphate (FDUMF). These products of a metabolism destroy cellular structure thanks to two various mechanisms of action.
First of all this binding of a folatny cofactor N5-10-metilentetragidrofolata and FDUMF with timidilatsintazy, leading to formation of a covalent tertiary complex which oppresses process of allocation of uracil of thymidylate, the necessary predecessor of thymidinetriphosphate. The lack of the thymidinetriphosphate necessary for normal synthesis of DNA leads to suppression of cell fission of a tumor.
Also transkriptsionny enzymes of a kernel in the course of RNA replication can include instead of uridine of triphosphate in its structure FUTF that, in turn, becomes the reason of disturbances of proteinaceous synthesis and processing of RNA.
After peroral (in) reception there is rather fast and actually full absorption of a kapetsitabin, to its further transformation and allocation of metabolites 5 -DFUR and 5 -DFTsT (5 -dezoksi-5-ftortsitidin). Joint administration of drug with food reduces the speed of its absorption, and also slightly influences AUC 5 -DFUR and a further product of its metabolism – 5-FU. Cmax of a kapetsitabin at its one-time reception by patients with serious tumors equaled 2,96 mkg/ml, and its metabolite 5 -DFUR – 5.73 mkg/ml. Tmax made: 0.27-4.05 hour for a kapetsitabin and 0.5-4.13 hours for the 5th -DFUR-metabolita; AUC in 24 hours respectively: 3.97 мкг×ч/мл and 10.87 мкг×ч/мл; AUCinf respectively: 5.12 мкг×ч/мл and 12.1 мкг×ч/мл.
Linkng with plasma proteins (generally) in vitro happens to albumine for a kapetsitabin for 54%, for 5 -DFTsT for 10%, for 5 -DFUR for 62% and for 5-FU for 10%.
Primary metabolic transformations of a kapetsitabin under the influence of a karboksilesteraza happen in a liver to allocation of the 5th -DFTsT-metabolita which further, by means of the cytidinedeaminase which is generally in tumoral fabrics and a liver is transformed to the 5th -DFUR-metabolit. The subsequent transformation to active cytostatic 5 mainly mainly happens in tumoral fabrics under the influence of thymidinephosphorylase. Cytotoxic influence of metabolites of a kapetsitabin is shown only after their transformation in 5-FU and products of its metabolism.
The further catabolism 5-FU proceeds with transformation to inactive metabolites – α-ftor-β-alanin (FBAL), 5-ftorureidopropionovy acid and dihydro-5-ftoruratsil by means of a dihydropyrimidindehydrogenase thanks to which also speed of response is limited.
Average T1/2 of a kapetsitabin is equal 0.8 hours, and the 5th -DFUR-metabolita 0.6 hours. In the therapeutic dosing range the pharmacokinetics of a kapetsitabin and products of its metabolism, except for 5, is dozozavisimy.
The main removal of a kapetsitabin and products of its metabolism (about 95%) is carried out by kidneys (3% in not changed look). About 2,9% of drug are excreted by intestines.
The sex of the patient, absence or existence of metastasises at him in a liver, activity of ACT and ALT, the general condition of the patient, level of bilirubin and plasma albumine did not exert significant impact on pharmacokinetics 5-FU, 5 -DFUR and FBAL of metabolites of a kapetsitabin. At patients with slight and moderately severe pathologies of a liver which were caused by metastasises did not observe clinically significant disturbances of pharmacokinetics of a kapetsitabin. Authentic data on change of pharmacokinetic parameters at patients with heavy hepatic pathologies do not exist today.
The Clearance of Creatinine (CC) does not influence pharmacokinetics of a kapetsitabin and it 5 in any way, but at decrease twice influences increase in AUC 5 of a -DFUR-metabolita approximately for 35%.
Racial accessory of patients and their age do not exert impact on pharmacokinetic indicators of 5-FU and 5 -DFUR-metabolitov.
Indications to use
Tutabin is shown to appointment for:
- monotherapies of a metastatic or locally-spread breast cancer, insensitive to chemotherapy drugs of an anthracycline or taksanovy row, and also in the presence at the patient of contraindications to their use;
- the combined treatment of a metastatic or locally-spread breast cancer together with dotsetaksely, in case of inefficiency of the carried-out chemotherapy medicines of an anthracycline row;
- therapies of a widespread carcinoma of the stomach, as drug of the first line;
- treatments of a metastatic colorectal cancer;
- adjuvant therapy of the III stage of a colon cancer, after carrying out surgical treatment.
Tutabin's use is absolutely contraindicated at:
- renal failure in a heavy stage (at KK it is less than 30 ml/min.);
- personal hypersensitivity to a kapetsitabin or other components of HP;
- personal hypersensitivity to Ftoruratsil;
- feeding by a breast;
- earlier noted cases of development of heavy or unexpected negative reactions to therapy with use of derivatives of Ftorpirimidin;
- carrying out treatment by Sorivudin, and also its structural analogs (for example, Brivudin);
- the diagnosed insufficiency of a dihydropyrimidindehydrogenase;
- initial level of thrombocytes there is less 100×109/л and/or neutrophils less 1.5×109/л;
- the existing contraindications to other drug from the used combination therapy;
- at children's age.
Tutabin's appointment with care is possible at:
- coronary heart disease;
- intolerance of sugars;
- liver pathologies;
- the combined treatment with coumarinic peroral anticoagulants;
- medium-weight pathologies of kidneys;
- at advanced age (after 60 years).
The negative reactions observed at Tutabin's use in monotherapy.
- hypersensitivity phenomena.
- digestion disturbance;
- loss of appetite;
- manifestations of a diabetes mellitus;
- weight reduction.
- memory disturbance;
- lack of coordination and sense of equilibrium;
- peripheral neuropathy.
- pain in ears;
- the suppressed mood;
- panic attacks;
- decrease in a libido;
- confusion of consciousness.
Organs of sight:
- irritation of mucous;
- excessive slezootdeleniye;
- decrease in visual function.
Bodies of a hemopoiesis:
- increase in a prothrombin time;
- febrile neutropenia;
- hemolitic anemia;
- stomatitis (including ulcer);
- abdominal pains;
- dryness in an oral cavity;
- bloody stools;
- gastrointestinal tract bleedings;
- gastroezofagalny reflux;
- intestinal impassability;
- sensation of discomfort in an abdominal cavity.
- dorsodynia and extremities;
- muscular weakness;
- constraint in joints and muscles;
- puffiness of joints.
- unstable stenocardia;
- cold snap of extremities;
- change of the ABP (in this or that party);
- myocardium ischemia;
- tachycardia (including sinus);
- deep vein thrombosis;
- fibrillation of auricles;
- feeling of "inflow";
- heart consciousness.
Zhelchevyvodyashchy ways and liver:
- disturbance of hepatic function;
- displays of jaundice.
- macular rash;
- palmar and bottom syndrome (hypostases, paresthesias, hyperemia, blistering, peeling);
- pigmentation disturbances;
- skin ulcerations;
- damage of nails;
- skin desquamation;
- small tortoiseshell;
- palmar erythema;
- face edema.
- nasal bleedings;
- pulmonary embolism.
- increased fatigue;
- temperature increase;
- grippopodobny states;
- peripheral hypostases;
- feeling of alarm.
- herpes infection;
- tooth abscess;
- infections of the lower ways of breath;
- fungal infections;
- infections of an urinary system;
- inflammations of hypodermic cellulose;
- candidiasis mucous mouth.
The toxicity reactions observed at use of ftorpirimidin (which are indirectly connected with reception of a kapetsitabin).
- gastrointestinal tract bleedings;
- dryness in a mouth;
System of a hemopoiesis:
- miyelosupressiya / pancytopenia;
- puffiness of the lower extremities;
- supraventricular arrhythmias;
- ventricular extrasystoles;
- myocardium ischemia;
- heart failure;
- myocardial infarction;
- fibrillation of auricles;
- sudden death.
- taste disturbance;
- confusion of consciousness;
- peeling of skin (focal);
- change of nails;
- syndrome similar to beam dermatitis.
- asthma (in particular at loadings);
- irritation of eyes.
- the infectious pathologies of various genesis (bacterial, fungal, virus) connected with immunity easing, a miyelosupressiya and/or disturbances mucous and also sepsis.
- the increased drowsiness;
- extremity and breast pain;
Also in some cases were registered: cholestatic hepatitis, a liver failure and a stenosis of the lacrimal tubule, with unproven relationship of cause and effect using a kapetsitabin.
In case of a combination of a kapetsitabin with other chemotherapeutic HP, seldom (less than 5%) observed: ischemia/myocardial infarction (3%), hypersensitivity phenomena (2%).
Tutabin, application instruction
Tutabin's tablets are shown to be accepted orally (inside) not later than half an hour after meal and to wash down with water.
Standard schemes of therapy using drug Tutabin of 500 mg are given below. Standard (1250 mg/sq.m) and lowered (800-1000 mg/sq.m) dosages of drug are calculated proceeding from body surface area with use of the special tables provided in the official instruction or special literature.
For treatment of malignant tumors of a mammary gland, a large intestine and a colorectal cancer appoint two times (in the morning and in the evening) daily reception of 1250 mg/sq.m of Tutabin (generally 2500 mg/sq.m in 24 hours) for 14 days, with the subsequent week break.
The combined treatment
For therapy of a breast cancer appoint two times daily reception of 1250 mg/sq.m of Tutabin for 14 days, with the subsequent week break, together with hour infusion of a dotsetaksel in the dose of 75 mg/sq.m which is carried out once in 21 days. Before infusional introduction of a dotsetaksel the premedication corresponding to the instruction for its use is carried out.
For a cancer therapy of a stomach and a colorectal cancer appoint two times daily reception of 800-1000 mg/sq.m of Tutabin for 14 days, with the subsequent week break. Also practice the continuous scheme of therapy with two times daily reception to 625 mg/sq.m. Parallel reception of immunobiological drugs does not exert impact on Tutabin's dosages.
For adjuvant therapy of a malignant tumor of a large intestine Tutabin's pill is recommended to take for 6 months (that is to conduct 8 standard therapeutic courses).
Purpose of antiemetic drugs and carrying out premedication for the purpose of ensuring reasonable hydration is carried out before introduction of Cisplatinum according to instructions to Cisplatinum and Oksaliplatin.
Correction of the dosing mode
At Tutabin's use, the toxic phenomena arising during monotherapy eliminate with purpose of a symptomatic treatment and/or the correction of the dosing mode including decrease in doses or full refusal of drug use. In case of decrease in dosages of Tutabin their subsequent increase is inadmissible.
The assessment of toxic influence of Tutabin and possibility of its further use in the initial or lowered dosages, and also therapy cancellations, are carried out by exclusively attending physician, according to degree of the toxicity of drug making threat to health or the patient's life.
At the 1st degree of toxicity of a dosage of Tutabin remain invariable.
At the first identification of the 2nd degree of toxicity therapy is interrupted before decrease in toxic symptomatology at least to the 1st degree then resume treatment in a full dose of Tutabin. In case of secondary manifestation of the 2nd degree of toxicity, after leveling of its symptomatology, resume treatment in the dose making a third of full. At the third detection of the 2nd degree of toxicity such dose will be twice less initial. The fourth detection of the 2nd degree of toxicity demands full cancellation of treatment.
At the first identification of the 3rd degree of toxicity therapy is interrupted before decrease in toxic symptomatology at least to the 1st degree then resume treatment in the dose lowered by 25%. In case of secondary manifestation of the 3rd degree of toxicity, after leveling of its symptomatology resume treatment in 50% to a dose from full. The third detection of the 3rd degree of toxicity demands full cancellation of treatment.
At the first identification of the 4th degree of toxicity therapy is interrupted before decrease in toxic symptomatology at least to the 1st degree then resume treatment in 50% to a dose from full. The second detection of the 4th degree of toxicity demands full cancellation of treatment.
The patient is obliged to report to the doctor about the negative manifestations developing at him immediately. In case of identification of symptomatology of average or heavy degree of toxicity it is necessary to interrupt immediately Tutabin's reception, up to its significant decrease (to the 1st degree). If during this time several next receptions of Tutabin by force were missed, unused doses of drug should not be filled.
At manifestation of hematologic toxicity of Tutabin of the 3rd or 4th severity carrying out therapy needs to be stopped.
In case of detection of the toxic phenomena during the combined treatment it is necessary to follow instructions on correction of the dosing mode given above, and also to all recommendations stated in instructions to use of the other medicines used in a combination therapy.
If at the beginning of the next cycle of a combination therapy the delay of use any of the drugs used in it is expected, it is necessary to detain a course of treatment up to a possibility of full use of all medicines. Detection of the toxic phenomena at a stage of carrying out a course of the combined treatment which are objectively not connected with reception of tablets of Tutabin demands purposes of symptomatic therapy, or decrease in dosages relatively in parallel of the used drug or their sum, without cancellation of reception of Tutabin.
In case of need cancellations in parallel used one or several drugs continuation of therapy by Tutabin at satisfactory indications of a condition of the patient to its use is possible. These recommendations are pertinent in relation to all special groups of patients at all observed pathologies.
Treatment of patients by Tutabin with hepatic metastasises, and also patients with pathologies of a liver of easy or moderate temper does not demand initial correction of the dosing mode, however in such cases there is a need of careful supervision over a condition of function of a liver. For this time there is no experience of therapy of patients with a heavy hepatic unsufficiency.
Therapy of patients with pathologies of kidneys of easy temper (at KK of 51-80 ml/min.) is carried out in full dosages of Tutabin. At the moderate lowered function of kidneys (at KK of 30-50 ml/min.) recommend to begin treatment by Tutabin in the dosage lowered for 25%. In case of negative manifestations 2-oh-4-oh degree should interrupt the carried-out therapy, to carry out a symptomatic treatment and to modify further dosages it agrees to the above-stated recommendations. If during therapy lowering of KK to 30 ml/min. and less is observed, reception of tablets of Tutabin should be cancelled.
Tutabin's use for treatment of elderly patients, as a rule, does not demand initial correction of doses of drug. However its use in monotherapy of patients is more senior than 80 years and in combinatory treatment with other antineoplastic drugs of patients is more senior than 65 years showed more frequent emergence of the negative phenomena of the 3rd and 4th degree that assumes carrying out careful monitoring of a condition of such patients.
The combination therapy using Tutabin and Dotsetaksel of patients is more senior than 60 years often led to undesirable manifestations of the 3rd and 4th degree, and also to other serious negative effects. In this regard, carrying out such combinatory treatment concerning patients is more senior than 60 years needs initial purpose of reduced doses of Tutabin before two times daily reception of 950 mg/sq.m. Tutabin's combination with Irinotekan for treatment of patients is more senior than 65 also demands initial decrease in doses of Tutabin to 800 mg/sq.m twice at 24 o'clock.
At acute overdose by Tutabin observed: nausea with the subsequent vomiting, mukozit, diarrhea, irritation and bleedings of a gastrointestinal tract, and also suppression of functionality of marrow.
Therapy of such states demands purpose of a standard complex of the adequate supporting and therapeutic measures directed to leveling of clinical symptomatology and the prevention of probable complications.
Parallel reception of a kapetsitabin with coumarinic anticoagulants (Fenprokumon, Warfarin) can lead to disturbances of coagulability of blood, and also increases risk of developing of bleedings. These complications most often observed in several days or months after purpose of a kapetsitabin, and sometimes and for the first month after the treatment termination. At one-time introductions of 20 mg of Warfarin, against reception of a kapetsitabin, its MHO increased by 91%, and AUC for 57%. At the combined reception of a kapetsitabin and coumarinic anticoagulants it is necessary to watch closely indicators of coagulability of blood (measuring MHO or a prothrombin time) and to select an anticoagulant dosage taking into account these indicators.
The directed researches of interaction of a kapetsitabin with other drugs which metabolism passes P450 cytochrome with participation of system namely its isoenzyme CYP2C9, was not carried out, however parallel appointment of Tutabin with similar medicines should be carried out carefully.
Increase of plasma concentration of Phenytoinum at its joint reception with kapetsitabiny was noted. The expected mechanism of such action is connected with suppression kapetsitabiny CYP2C9 isoenzyme. In this regard, Tutabin's combination and Phenytoinum demands regular control over plasma keeping of the last.
The combined Tutabin's reception with the drugs of antiacid action including magnesium hydroxide or aluminum leads to small increase of plasma maintenance of a kapetsitabin and its 5th -DFTs-metabolita. Antacids of influence did not render on serumal concentration of other metabolites of a kapetsitabin.
Simultaneous treatment using Tutabin and calcium of a folinat does not influence pharmacokinetics of a kapetsitabin and products of its metabolism. Nevertheless, impact of calcium of a folinat on a pharmacodynamics of a kapetsitabin can lead to strengthening of its toxic action.
There are descriptions of clinically significant medicinal interaction of Ftoruratsil and Sorivudin which thanks to inhibition sorivudiny dihydropyrimidindehydrogenases can become the reason of fatal increase in toxic effects of ftorpirimidin. In this regard it is necessary to avoid co-administration of Tutabin and Sorivudin, and also its structural analogs (for example, Brivudina). Minimum admissible interval between use of these drugs has to make 4 weeks.
Use of Allopyrinolum against therapy by Tutabin can lead to decrease in efficiency of a kapetsitabin.
The most transferable dosage of a kapetsitabin at the combined use from 6 million ME/sq.m Interferon alpha 2а in days went down from 3000 mg/sq.m to 2000 mg/sq.m at 24 o'clock, in comparison with use of a kapetsitabin in monotherapy.
Clinically significant differences in exposure of a kapetsitabin or products of its metabolism, and also the general and untied platinum at combinatory treatment with Oksaliplatin's use and a kapetsitabina, in independence of presence of a bevatsizumab were not noted.
Clinically significant impact of a bevatsizumab on pharmacokinetic features of a kapetsitabin or products of its metabolism in the presence of an oksaliplatin was not noted.
When using the standard dosing mode in monotherapy, the most transferable dosage of a kapetsitabin was equal to 3000 mg/sq.m a day. Reception of tablets of Tutabin in parallel with carrying out radiation therapy (a course Monday through Friday for 6 weeks) for the purpose of treatment of a colorectal cancer led up to 2000 mg/sq.m to reduction of this parameter.
Terms of sale
Tutabin can buy, having only shown the recipe.
The maximum temperature indicator of storage of tablets of Tutabin – 30 °C.
Period of validity
It is possible to take Tutabin's pill for 2 years from the moment of their production.
Throughout the entire period of reception of tablets Tutabin it is necessary to carry out careful monitoring of toxic manifestations constantly.
The majority of the negative phenomena of therapy with use of a kapetsitabin are reversible and, as a rule, do not demand complete cessation of treatment, however situations of need of correction of the dosing mode or temporary interruption of therapy can take place.
Tutabin's reception can sometimes lead to development of diarrhea, occasionally in a severe form. In case of forming of heavy diarrhea it is necessary to establish a constant control over a condition of the patient, for the purpose of timely leveling of displays of possible dehydration and compensation of the lost electrolytes. (For example, Loperamide) it is necessary to appoint anti-diarrheal standard medicines on medical indications as soon as possible. Such states can sometimes demand decrease in dosages of Tutabin.
Dehydration most quicker develops at patients with an adynamy, diarrhea, anorexia or vomiting and demands the prevention or elimination at the very beginning of the emergence. In case of development of significant dehydration (since the 2nd severity) reception of tablets of Tutabin it is necessary to stop and carry out procedures for a regidratation immediately. Resuming of therapy is possible only after end of a regidratation and adjustment or elimination of the factors which caused it. The further dosage of a kapetsitabin has to be reconsidered according to the recommendations about leveling of the negative phenomena which became dehydration reason given above.
The cardiotoxicity range observed at reception of a kapetsitabin, similar to that at use of other ftorpirimidin including changes on an ECG, a myocardial infarction, cardiogenic shock, arrhythmias, stenocardia and sudden death. These negative manifestations are most often observed at patients from earlier diagnosed ischemic heart disease. There are messages of development of arrhythmia, heart failure, a myocardial infarction and a cardiomyopathy at therapy kapetsitabiny. There is a need of respect for extra care at Tutabin's appointment to patients at whose anamnesis there are references to arrhythmias, the expressed pathologies of heart and stenocardia. In certain cases the heavy unexpected toxic phenomena (for example, diarrhea, a neurotoxicity, stomatitis, a neutropenia) associated with carrying out therapy of a ftorpirimidinama arose because of insufficient activity of a dihydropyrimidindehydrogenase. Proceeding from it, it is impossible to exclude completely communication between weak activity of a dihydropyrimidindehydrogenase and heavy toxicity (potentially lethal) of ftorpirimidin.
Skin toxicity characteristic of Tutabin is shown by forming of a palmar and bottom syndrome (the akralny erythema or a palmar and bottom eritrodizesteziya caused by carrying out chemotherapy). At monotherapy kapetsitabiny the time span of development of such toxic manifestations makes 11-360 days, and degree of their weight fluctuates from the 1st to the 3rd. The Akralny erythema of the 1st degree does not lead to disturbance of daily activity of the patient and is characterized dizesteziyami / paresthesias, numbness, a pricking, discomfort and a hyperemia of soles or palms. the 2nd extent of complication is shown painful by hypostases and reddening of feet and/or brushes, and these symptoms break everyday activity of the patient. The symptomatology of the 3rd degree of this syndrome differs in wet desquamation, formation of bubbles, ulcerations and sharp painful feelings in feet and/or in brushes, and also rather strong feeling of discomfort which makes impossible carrying out by the patient any manipulations connected with daily activity. At detection at the patient of symptoms characteristic of the 2nd or 3rd degree of a palmar and bottom syndrome, treatment by Tutabin is temporarily stopped, up to their full leveling or decrease to the 1st degree. In case of negative manifestations of the 3rd degree further therapy should be carried out by the lowered Tutabin's dosages.
If the akralny erythema appears at a combination therapy of Tutabin with Cisplatinum, for its treatment do not recommend to use the Pyridoxine (vitamin B), owing to its negative impact on efficiency of Cisplatinum.
Treatment by Tutabin can lead to a hyperbilirubinemia. In case of the given complication with bilirubin parameters more 3.0×ВГН (the upper bound of norm) or increase in level of aminotransferases of a liver (ALT, ACT) more 2.5×ВГН, therapy by Tutabin should be stopped temporarily. Resuming of treatment is possible only at decrease in indicators of bilirubin and aminotransferases of a liver below the listed limits.
The patients in parallel accepting Tutabin and peroral coumarinic anticoagulants have to be under a constant control of coagulability of blood (checking MHO or a prothrombin time), with correction of the dosing mode of a kapetsitabin according to these indications.
Frequency of the phenomena of toxic character from a gastrointestinal tract at patients at the age of 60-79 with a colorectal cancer passing monotherapy by Tutabin did not exceed that at younger age. Patients are more senior than 80 years experienced negative reversible complications of the 3rd and 4th degree from a gastrointestinal tract, including diarrhea, nausea/vomiting more often. Patients are more senior than 65 years, being on the combined treatment using a kapetsitabin and other antineoplastic drugs, noted at themselves increase of undesirable manifestations of a gastrointestinal tract of the 3rd and 4th degree which demanded therapy cancellation. The analysis of indicators of safety of reception of Tutabin concerning patients is more senior than 60 years passing therapy with a combination of a kapetsitabin and a dotsetaksel, showed increase in frequency of negative manifestations of the 3rd and 4th degree, and also the other serious symptoms leading to early cancellation of a course of treatment in comparison with younger patients.
In case of Tutabin's reception by patients with pathologies of moderately severe kidneys (at KK of 30-50 ml/min.), the observed frequency of toxic complications of drug of the 3rd and 4th degree was higher, than at patients with healthy kidneys. Therefore Tutabin's appointment to such patients demands special approach and care.
The patients with insufficiency of hepatic function accepting Tutabin have to reside under careful supervision from medical personnel. Influence of the pathologies of a liver which are not connected with its metastatic defeat on distribution of a kapetsitabin was not studied.
At all stage of reception of Tutabin and at least on an extent of 3 months after its cancellation, patients of childbearing age should use reliable contraceptive methods / means. In case of approach of pregnancy during treatment kapetsitabiny it is necessary to inform the patient on a potential negative impact of the carried-out therapy on a fruit.
At the time of carrying out therapy by Tutabin it is necessary to treat carefully carrying out dangerous works and driving of the car, because of possible negative effects of treatment, including encephalopathy, confusion of consciousness and symptomatology of cerebellar disturbances (a dysarthtia, an ataxy, a lack of coordination and balance).
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