Indications for use
Mammary cancer
- combination therapy with docetaxel for locally advanced or metastatic breast cancer when chemotherapy that includes an anthracycline drug is ineffective;
- monotherapy for locally advanced or metastatic breast cancer resistant to chemotherapy with taxanes or anthracyclines or if there are contraindications to them.
Colorectal cancer
- adjuvant therapy for stage III colon cancer after surgical treatment;
- therapy for metastatic colorectal cancer.
Stomach cancer
- First-line therapy for advanced gastric cancer.
Instructions for use
The regimen for taking and dosing Tutabine tablets is determined by the doctor individually, taking into account the type of tumor, antitumor therapy regimen, stage of the disease, and the state of the hematopoietic system.
In the standard regimen, Tutabine tablets are prescribed at the rate of 2.5 g of the active substance for each square meter of the patient’s body area. The daily dose is divided into two doses and taken half an hour after meals. The duration of the course of therapy is 14 days, after a week's break it can be continued.
The dosage of Tutabine may be reduced if it is poorly tolerated.
Contraindications
- hypersensitivity to capecitabine or any other components of the drug;
- hypersensitivity to fluorouracil or with a history of reported cases of unexpected or severe adverse reactions to treatment with fluoropyrimidine derivatives;
- established deficiency of DPD (dihydropyrimide hydrogenase), as for other fluoropyrimidines;
- simultaneous administration of sorivudine or its structural analogues such as brivudine;
- severe renal failure (creatinine clearance below 30 ml/min);
- initial neutrophil content <1.5×109/l and/or platelets <100×109/l.
- if there are contraindications to one of the drugs in combination therapy, it should not be used;
- pregnancy and lactation;
- children's age (efficacy and safety of use have not been established).
Side effects of Tutabine
The instructions for Tutabin note that the use of this drug can lead to the development of side effects from various organ systems:
- From the gastrointestinal tract: stomatitis, epigastric pain, taste disturbances, hyperbilirubinemia, oral candidiasis, decreased appetite, flatulence, dry mouth, constipation or diarrhea, nausea, vomiting;
- From the nervous system: asthenia, sleep disturbances, dizziness, paresthesia, headache, weakness, increased fatigue;
- From the skin: cracks and/or hyperpigmentation of the skin, focal peeling, itching, alopenia, dermatitis, hand-foot syndrome.
Taking Tutabine, according to reviews, can lead to increased body temperature, increased lacrimation, swelling of the lower extremities, anemia, pain in the extremities and lower back.
special instructions
It is necessary to conduct careful medical monitoring of toxicity in patients receiving therapy with Tutabine.
Most adverse events are reversible and do not require complete discontinuation of the drug, although it may be necessary to adjust the dose or temporarily discontinue the drug.
It is likely that the drug Tutabin may have an undesirable effect on the ability to drive a car and operate machinery, since this drug can cause confusion, encephalopathy, symptoms of cerebellar disorders (ataxia, dysarthria, impaired balance and coordination), and increased drowsiness.
Pharmacological action of Tutabine
Tutabine has a selective cytotoxic effect. Once in tumor cells, it is converted into 5-fluorouracil under the influence of the tumor angiogenic factor (thymidiphosphorylase). The activity of thymidine phosphorylase in the tissues of malignant tumors is several times higher than in the cells of healthy tissue or blood. Therefore, the concentration of 5-fluorouracil in them is 4 times higher. As a result of further metabolism of 5-fluorouracil, 5-fluorourdine triphosphate and 5-fluoro-2-deoxyuridine monophosphate are formed, which have a powerful cytotoxic effect.
Interaction with other drugs
When using Tutabine tablets simultaneously with:
- coumarin anticoagulants - blood clotting indicators may be disrupted and bleeding may develop;
- phenytoin – the concentration of phenytoin in plasma increases;
- antacids containing magnesium and aluminum hydroxide - the concentration of capecitabine increases;
- calcium folinate – increases the toxic effect of capecitabine;
- sorivudine and its analogues - inhibits the activity of dihydropyridine dihydrogenase with a fatal increase in the toxicity of fluoropyrimidine.
Who is it contraindicated for?
Reasons why taking the drug is contraindicated or limited may be:
- High sensitivity (hypersensitivity reaction).
- The presence of severe renal and liver failure.
- Various stages of pregnancy (the drug affects the fetus), with the exception of cases when the life of the mother is given priority;
- Breastfeeding a newborn.
Also, the use of capecitabine is limited for people with coronary heart disease (CHD), in a state of increased concentration of bilirubin in the blood, liver damage by metastases with a violation of its basic functions. The drug is not recommended for minor children and elderly people. This is confirmed by the instructions for the drug "Capecitabine". Reviews from patients indicate many side effects and toxicities during treatment. Therefore, capecitabine therapy is carried out under the strict supervision of an oncologist.
Preparations and analogues
There are several capecitabine-based products. There are 7 trade names of drugs on the Russian market, produced by several domestic and foreign companies. For example:
- "Capecitabine".
- "Capecitabine-TL".
- "Tutabin."
- "Xeloda."
- "Cabetzin".
- "Capecitover".
- "Capamethine FS".
Since all these drugs are based on the same active ingredient - capecitabine, the instructions for them will be similar. Usually it contains a table for calculating dosage taking into account body weight and a treatment adjustment scheme if signs of toxicity of varying degrees occur.
It is important to understand that the first thing you should read when, for example, Capecitabine TL was prescribed is the instructions. The information provided in it is not suitable for independent use of the products! All calculations related to setting the dose and treatment regimen are made by the attending physician - an oncologist who has sufficient competence in this matter. Self-administration of antitumor drugs causes irreparable harm to the body.
Let's take a closer look at some of the drugs.
Analogs are cheaper than Tutabine
Based on the active substance, you can build the following series of synonyms for this drug:
- Xeloda;
- Cabecin;
- Capecitover;
- Capecitabine;
You can buy Xeloda in pharmacies, however, this analogue is not cheaper than Tutabine - when converted to the same dose and number of tablets, the price difference is about 9,000 rubles (not in favor of Xeloda).
Residence of the substance in the body
After taking capecitabine, it is rapidly absorbed from the gastrointestinal tract. If you eat at this time, the process will slow down. Therefore, drugs based on antimetabolites are taken after meals. Further transformations of the substance occur in the liver; a certain amount of capecitabine and its metabolites binds to proteins (for example, blood albumin). Peak levels in blood plasma are achieved 1.5-3 hours after administration of the drug. This is indicated in the instructions for the drug "Capecitabine". The analogues have similar pharmacokinetics.
Most of the substance is excreted in urine, less in feces. Moreover, not only capecitabine leaves the body unchanged (about 3%), but also its derivatives. Some of them are metabolized to less active compounds. The stay and transformation of capecitabine in the body is not affected by gender, age, or race.
Directions for use and dosage
The tablets are taken orally, no later than half an hour after meals.
For monotherapy, 1250 mg/m2 of Tutabine is prescribed twice a day (morning and evening) for 2 weeks, followed by a 7-day break. The total daily dose of the drug is 2500 mg/m2.
Recommended doses of Tutabine as part of combination therapy:
- colorectal cancer and stomach cancer: 800–1000 mg/m2 twice a day for 2 weeks, followed by a 7-day break; an alternative regimen is 625 mg/m2 twice a day in a continuous mode. The dose of Tutabine does not depend on the immunobiological drugs added to the combination treatment. For colon cancer, the duration of adjuvant therapy is 6 months, that is, 8 courses. Before administering cisplatin, premedication is carried out (according to the instructions for the use of cisplatin and oxaliplatin) and antiemetics are prescribed;
- breast cancer: 1250 mg/m2 twice a day for 2 weeks, followed by a 7-day break; in combination with docetaxel - 75 mg/m2 once every 3 weeks as an intravenous infusion over 1 hour. Before administering docetaxel, premedication is performed (according to the instructions for use of docetaxel).
The toxic effects of Tutabine are eliminated by adjusting its dose and/or prescribing symptomatic treatment. If the dose of the drug has been reduced, it cannot be increased subsequently.
In case of grade 1 toxicity, the dose of Tutabine is not changed. If grade 2 or 3 toxicity occurs, treatment should be interrupted. If signs of toxicity disappear or decrease to grade 1, drug therapy can be resumed at full dose or partially adjusted. In case of grade 4 toxicity, treatment should be completely stopped or temporarily interrupted until the symptoms of toxicity decrease to grade 1 or are relieved. After this, therapy can be resumed by prescribing a dose of 50% of the initial dose.
When carrying out combined treatment and signs of toxicity occur, it is necessary to determine whether these phenomena are related to taking Tutabine. If the symptoms of toxicity, in the opinion of the physician, are due to the use of other drugs, treatment with Tutabine should be continued, and the doses of other drugs should be adjusted in accordance with the recommendations in the instructions for use of these drugs.
In mild to moderate liver dysfunction and liver metastases, no initial dosage adjustment is required, but such patients should be closely monitored.
In case of mild renal failure, no adjustment of the initial dose of the drug is required; in case of moderate renal failure, it is recommended to reduce the initial dose to 75% of 1250 mg/m2.
In senile and elderly patients, no adjustment of the initial dose is required, however, in such patients, undesirable side reactions develop more often than in younger patients.
What precautions should you take?
The course of treatment must be carried out under close medical supervision. The specialist must promptly identify toxic manifestations - be it nausea, diarrhea, etc. If these signs are detected, the treatment is adjusted. If necessary, eliminate symptoms, reduce the daily dose, and take a break. Treatment is continued if signs of toxicity are not life-threatening.
For people with coronary heart disease, specialist supervision should be especially thorough. In this case, it is necessary to identify the negative impact on the cardiovascular system in time and take the necessary measures in time.
Experts refrain from using the substance in pediatric practice. The effectiveness of its use in children has not been established. If a woman of childbearing potential is treated, she should be warned about the effects of capecitabine on the fetus. She should use reliable contraceptives during therapy.
Reviews about Tutabine
On the Internet, on forums dedicated to oncology problems, there are reviews of Tutabine from both doctors and patients. Of course, in each specific case the situation is different and, accordingly, the attitude towards the drug and the entire treatment is different. But, in general, the reaction to Tutabin is no different from the reaction to Xeloda, which is more widely known:
— Dad had his first course with Xeloda. And now they are giving out Tutabin. We were worried at first, but the doctor said there was no difference. It seems, really not.
— My sister has already had several courses of Tutabine successfully. Feels relatively good. We shouldn't have worried that he was worse than Xeloda.
— During chemotherapy with Tutabine, the skin of my feet was very damaged - all cracked. We apply Dexpanthenol.
The main thing that can be gleaned from these reviews is that Tutabin is an adequate analogue of Xeloda. Even with several consecutive courses of chemotherapy, one drug can be replaced by another. There are many examples of the good effectiveness of this medicine. Patients can receive Tutabine in oncology centers free of charge. And your doctor will tell you about the prospects for treatment in each individual case.
Release form and composition
Tutabine is available in the form of film-coated tablets: biconvex, orange-pink in color (10 pieces in blisters, 12 blisters in a cardboard package).
Composition of 1 tablet:
- active ingredient: capecitabine – 500 mg;
- auxiliary components: microcrystalline cellulose, colloidal silicon dioxide, lactose, magnesium stearate, povidone, corn starch, croscarmellose;
- film shell: opadry II orange (titanium dioxide, red aluminum varnish, polyvinyl alcohol, yellow aluminum varnish, macrogol).
