Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Antitumor agent. It has a selective cytotoxic effect. In tumor tissue, capecitabine is converted to 5-fluorouracil by thymidine phosphorylase (tumor angiogenic factor).Thymidine phosphorylase activity in the primary tumor is 4 times higher than in healthy tissue, so the concentration of 5-fluorouracil in tumor tissue is higher than in healthy tissue and in plasma.
In both healthy and tumor cells, 5-fluorouracil is metabolized to form 5-fluoro-2-deoxyuridine monophosphate and 5-fluorouridine tri-phosphate, which have a cytotoxic effect.
INDICATIONS
Locally distributed or metastatic breast cancer, if chemotherapy is ineffective, including paclitaxel and an anthracycline agent, or if there are contraindications to anthracycline therapy.
DOSING MODE
Established individually, depending on the indications and stage of the disease, the state of the hematopoiesis system, the scheme of antitumor therapy.
SIDE EFFECT
On the part of the digestive system: diarrhea, nausea, vomiting, stomatitis, abdominal pain, constipation, epigastric pain, indigestion, dry mouth, flatulence, mild stools, anorexia, impaired appetite, oral candidiasis, hyperbilirubinemia, taste disorders.
From the side of the nervous system: increased fatigue, weakness, pronounced drowsiness, headache, paresthesia, dizziness, sleep disturbances, asthenia.
From the skin and subcutaneous tissues: palmar-plantar syndrome, dermatitis, dry skin, alopecia, itching, focal peeling, hyperpigmentation of the skin, skin cracks.
Other: increased lachrymation, fever, possible dehydration, weight loss, dyspnoea, cough, pain in the extremities, low back pain, myalgia, cardiotoxic effect (most likely in patients with ischemic heart disease), edema of the lower extremities, anemia.
CONTRAINDICATIONS
Severe unpredictable reactions in the history of fluoropyrimidine treatment, increased sensitivity to capecitabine and 5-fluorouracil.
PREGNANCY AND LACTATION
Adequate and strictly controlled clinical studies of the safety of capecitabine in pregnancy have not been conducted. In experimental studies, it was shown that capecitabine has a fetotoxic and teratogenic effect. Application in pregnancy is not recommended. Women of childbearing age in the period of treatment should use reliable methods of contraception.
It is not known whether capecitabine is excreted in breast milk. If it is necessary to use during lactation, the expected benefit of treatment for the mother and the child's risk should be assessed.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
During the treatment period, patients with mild to moderate liver function disorders caused by metastases to the liver require careful monitoring by the physician.
APPLICATION FOR CHILDREN
The safety and efficacy of capecitabine in children has not been studied.
APPLICATION IN ELDERLY PATIENTS
During the treatment of the elderly, careful monitoring of the physician is required.
SPECIAL INSTRUCTIONS
During the treatment period, patients with mild and moderate liver function disorders caused by metastases to the liver, and the elderly need careful monitoring of the doctor.
With moderate or severe hyperbilirubinemia, capecitabine should be temporarily discontinued until recovery to mild severity.
The safety and efficacy of capecitabine in children has not been studied.
Impact on the ability to drive vehicles and manage mechanisms
Use with caution in patients involved in potentially hazardous activities that require a high concentration of attention and speed of psychomotor reactions.
DRUG INTERACTION
With the simultaneous use of capecitabine with coumarin anticoagulants, there may be a disruption in blood coagulation and bleeding (it is necessary to regularly monitor coagulation parameters).
