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Capecitabine

Pharmasyntez
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2019-06-23
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Clinical Pharmacology

Antitumor agent, antimetabolite

Indications

Mammary cancer

- Combination therapy with docetaxel of locally advanced or metastatic breast cancer with the ineffectiveness of chemotherapy, including the preparation of the anthracycline;

- monotherapy of locally advanced or metastatic breast cancer resistant to chemotherapy with taxanes or anthracycline drugs or in the presence of contraindications to them.

Colorectal cancer

- Adjuvant treatment of colon cancer stage III after surgical treatment;

- Therapy of metastatic colorectal cancer.

Stomach cancer

- First-line treatment for advanced gastric cancer.

Composition

1 tab. - capecitabine 500 mg

Excipients: lactose - 91.11 mg, microcrystalline cellulose - 91.11 mg, croscarmellose sodium - 32.8 mg, hypromellose - 2.02 mg, magnesium stearate - 10.93 mg.

Shell composition: film coating - 6.56 mg (hypromellose - 38.46%, talc - 30.77%, titanium dioxide (E171) - 29.41%, iron dye red oxide (E172) - 0.68%, iron dye yellow oxide (E172) - 0.68%) .

Capecitabine is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Capecitabine Pharmasyntez Russia pills
Tutabin Laboratory Tyutor S.A.S.I.F.I.A Argentina pills
Xeloda Hoffmann la roch Switzerland pills

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Capecitabine

Dosage and Administration

Inside, drinking water, no later than 30 minutes after eating.

Standard dosing regimen

Monotherapy

Colorectal, colon and breast cancer

At 1250 mg / m2 2 times a day - in the morning and in the evening (total daily dose of 2500 mg / m2) for 14 days, followed by a 7-day break.

Combination therapy

Mammary cancer

At 1250 mg / m2 2 times a day for 14 days, followed by a 7-day break, in combination with docetaxel at a dose of 75 mg / m2 once every 21 days as an intravenous infusion for 1 hour.

Premedication is carried out before the introduction of docetaxel in accordance with the instructions for its use.

Colorectal and stomach cancer

In combination therapy, the dose of capecitabine should be reduced to 800-1000 mg / m2 2 times a day for 14 days, followed by a 7-day break or to 625 mg / m2 2 times a day in continuous mode. Adding bevacizumab to combination therapy does not affect the initial dose of capecitabine.

Antiemetics and premedication to ensure adequate hydration are prescribed before administration of cisplatin and oxaliplatin in accordance with the instructions for use of cisplatin and xaliplatin when used in combination with capecitabine.

In adjuvant treatment of colon cancer, the recommended duration of capecitabine therapy is 6 months, i.e. 8 courses.

In combination with cisplatin

1000 mg / m2 2 times a day for 14 days, followed by a 7-day break in combination with cisplatin (80 mg / m2 1 time in 3 weeks, iv infusion for 2 hours, the first infusion is prescribed in the 1st cycle day). The first dose of capecitabine is prescribed in the evening on the 1st day of the therapy cycle, the last - in the morning on the 15th day.

In combination with oxaliplatin or oxaliplatin and bevacizumab

1000 mg / m2 2 times a day for 14 days followed by a 7-day break in combination with oxaliplatin or oxaliplatin and bevacizumab. The first dose of capecitabine is administered in the evening on the 1st day of the therapy cycle, the last - in the morning on the 15th day. Bevacizumab is administered at a dose of 7.5 mg / kg 1 time in 3 weeks, in / in the infusion for 30-90 minutes, the first infusion begins on the 1st day of the cycle. After bevacizumab, oxaliplatin is administered at a dose of 130 mg / m2, by iv infusion over 2 hours.

In combination with epirubicin and platinum-based drug

At 625 mg / m2 2 times a day in continuous mode in combination with epirubicin (50 mg / m 1 every 3 weeks, IV bolus, starting from the first day of the cycle) and a platinum-based preparation. The drug on the basis of platinum (cisplatin at a dose of 60 mg / m2 or oxaliplatin at a dose of 130 mg / m2) must be administered on the 1st day of the cycle as an IV infusion over 2 hours, then 1 time in 3 weeks.

In combination with irinotecan or irinotecan and bevacizumab

At 800 mg / m2 2 times daily for 14 days, followed by a 7-day break in combination with irinotecan or irinotecan and bevacizumab. Irinotecan is administered at a dose of 200 mg / m2 1 time per 3 weeks, by intravenous infusion for 30 minutes, the first infusion on the 1st day of the cycle. Bevacizumab is administered at a dose of 7.5 mg / kg 1 time in 3 weeks, in / in the infusion for 30-90 minutes, the first infusion begins on the 1st day of the cycle.

General recommendations

Toxic effects of capecitabine can be eliminated by symptomatic therapy and / or dose adjustment of the drug (interrupting treatment or reducing the dose of the drug). If the dose had to be reduced, you can not increase it later.

If, according to the evaluation of the attending physician, the toxic effect of capecitabine is not serious or life threatening in nature of the patient, treatment can be continued at the initial dose without reducing or interrupting therapy.

With 1st degree toxicity, the dose does not change. In case of 2nd or 3rd degree toxicity, capecitabine therapy should be interrupted.

With the disappearance of signs of toxicity or reduction of the latter to the 1st degree, therapy with capecitabine can be resumed in full dose or adjusted according to the recommendations indicated in table 3.

With the development of signs of toxicity of the 4th degree, treatment should be stopped or temporarily interrupted until the relief or reduction of symptoms to the 1st degree, after which the use of the drug can be resumed at a dose of 50% of the initial dose.The patient should immediately inform the doctor about his adverse events. Capecitabine should be discontinued immediately if severe or moderate toxicity occurs. If due to toxic effects several methods of capecitabine were missed, then these doses are not replenished.

Hematologic toxicity

Do not use capecitabine in patients with a baseline neutrophil level of less than 1.5x109 / l and / or baseline platelet levels <100x109 l="" capecitabine="" therapy="" should="" be="" interrupted="" if="" during="" an="" unscheduled="" assessment="" of="" laboratory="" parameters="" the="" number="" neutrophils="" is="" less="" than="" 1="" 0x109="" and="" platelets="" 75="" x="" 109="" hematological="" toxicity="" 3rd="" or="" 4th="" degree="" p="">

General recommendations for combination therapy

In the case of occurrence of toxicity during the combination therapy, the recommendations for capecitabine dose adjustment indicated in Table 3 above and the corresponding recommendations in the instructions for use of other drugs should be followed.

At the beginning of the cycle of therapy, if a delay in taking capecitabine or another (their) drug (s) is expected, all drugs should be postponed until conditions are reached to resume therapy with all drugs.

If, during the cycle of combination therapy, the phenomenon of toxicity, according to the physician, is not associated with the use of capecitabine, then therapy with capecitabine should be continued, and the dose of the other drug should be adjusted in accordance with the recommendations of the instructions for its use.

If another drug (s) has to be withdrawn, treatment with capecitabine can be continued if the requirements for resuming capecitabine therapy are met. These recommendations apply to all indications and all special patient groups.

Use in special patient groups

Liver dysfunction in patients with liver metastases

There is no need to change the initial dose in patients with liver metastases and mild or moderately impaired liver function. However, these patients should be carefully monitored. The use of the drug in patients with severe liver failure has not been studied.

Renal dysfunction

It is recommended to reduce the initial dose to 75% from 1250 mg / m2 in patients with an initial moderate degree of renal failure (CC 30-50 ml / min, according to the formula Cockroft-Gault). In patients with mild renal failure (CC 51–80 ml / min), no initial dose adjustment is required.

If a patient has an adverse event of 2nd, 3rd or 4th severity, it should be carefully monitored and immediate interruption of therapy should be carried out with a view to further adjusting the dose of the drug in accordance with the recommendations in Table 3. If the calculated creatinine clearance decreased during therapy to less than 30 ml / min, capecitabine therapy should be discontinued. Recommendations for the correction of the dose of the drug with an average degree of renal failure relate to both monotherapy and combination therapy.

The dose calculation is shown in Tables 1 and 2.

Children

The safety and efficacy of capecitabine in children has not been studied.

Elderly and senile patients

Correction of the initial dose in monotherapy with capecitabine is not required. However, severe adverse effects of the 3rd and 4th degree associated with the therapy, developed in patients older than 80 years more often than in younger patients.

When using capecitabine in combination with other anticancer drugs in elderly patients (aged> 65 years), adverse reactions of the 3rd and 4th severity, as well as adverse reactions that required discontinuation of therapy, were noted more often than in younger patients. Recommended careful monitoring of the condition of elderly patients.

When treated in combination with docetaxel in patients aged 60 years and older, there was an increase in the incidence of adverse events of grade 3 and 4 and serious adverse events associated with therapy. For patients aged 60 years and older who will receive a combination of capecitabine with docetaxel, it is recommended to reduce the initial dose of capecitabine to 75% (950 mg / m2 2 times a day). The calculation of the dose is given in Table 1. In the case of the absence of manifestations of toxicity, the dose can be increased to 1250 mg / m2 2 times a day.

When treated in combination with irinotecan in patients aged 65 years and older, it is recommended to lower the initial dose of capecitabine to 800 mg / m2 twice a day.

Adverse reactions

The incidence of adverse reactions is set out according to WHO recommendations: very often (> 10%), often (> 1% and <10%), infrequently (> 0.1% and <1%), rarely (> 0.01% and < 0.1%), very rarely (<0.01%).

The most frequent side effects associated with taking capecitabine were disorders of the gastrointestinal tract (GIT) (diarrhea, nausea, vomiting, abdominal pain, stomatitis), palmar and plantar syndrome, increased fatigue, asthenia, anorexia, cardiotoxicity, renal buildup failure in patients with impaired renal function in history, as well as thrombosis / embolism.

Side effects reported in patients taking capecitabine as monotherapy

Infectious and parasitic diseases: often - herpes viral infection, nasopharyngitis, infection of the lower respiratory tract; infrequently - sepsis, urinary tract infection, cellulitis, tonsillitis, pharyngitis, oral mucosa candidiasis, influenza, gastroenteritis, fungal infections, infections, tooth abscess.

Benign, malignant and unspecified neoplasms: infrequently - lipoma.

Disorders of the blood and lymphatic system: often - neutropenia; infrequently - febrile neutropenia, granulocytopenia, thrombocytopenia, leukopenia, hemolytic anemia, an increase in the international normalized ratio, lengthening of the prothrombin time.

Immune system disorders: infrequently - hypersensitivity. Metabolic and nutritional disorders: very often - anorexia; often - dehydration, weight loss; infrequently - diabetes, hypokalemia, indigestion, hypertriglyceridemia.

Psychiatric disorders: infrequently - panic attacks, depressed mood, decreased libido.

Nervous system disorders: often - headache, dizziness (except vertigo), lethargy, paresthesias, dysgeusia (taste perversion): not often - aphasia, memory disorder, fainting, imbalance, loss of sensitivity, peripheral neuropathy.

Violations on the part of the organ of vision: often - increased tearing, conjunctivitis; infrequently - decreased visual acuity, diplopia.

Disturbances of the organ of hearing and labyrinth disorders: infrequently - vertigo, pain in the ears.

Cardiac disorders: infrequently - angina, including unstable, arrhythmia, sinus tachycardia, palpitations.

Vascular disorders: often - thrombophlebitis; infrequently - deep vein thrombosis, high blood pressure, petechiae, low blood pressure, "hot flushes", cooling of the distal extremities.

Disorders of the respiratory system, organs of the chest and mediastinum: often - nosebleeds, rhinorrhea; infrequently - pneumothorax, hemoptysis, bronchial asthma, shortness of breath on exertion.

Disorders of the gastrointestinal tract: very often - diarrhea, vomiting, nausea, stomatitis (including ulcerative), abdominal pain; often - constipation, epigastric pain, dyspepsia; infrequently, intestinal obstruction, ascites, enteritis, dysphagia, lower abdominal pain, abdominal discomfort, gusgroesfagialny reflux disease, blood in the stool.

Disorders of the liver and biliary tract: often - a change in liver function tests; infrequently - jaundice.

Violations of the skin and subcutaneous tissues: very often - palmar and plantar syndrome (paresthesia, edema, hyperemia, peeling of the skin, blistering), dermatitis; often - hyperpigmentation of skin, macular rash, rash, alopecia, erythema, dry skin; infrequently - blister, skin ulcers, urticaria, palmar erythema, swelling of the face, purpura. In less than 2% of patients in 7 completed clinical studies (N = 949), skin cracks were reported, at least presumably related to capecitabine therapy.

Disorders of the musculoskeletal and connective tissues: often - pain in the limbs, back pain; infrequently - swollen joints, bone pain, facial pain, stiffness, muscle weakness.

Disorders of the kidneys and urinary tract: infrequently - hydronephrosis, urinary incontinence, hematuria, nocturia, increased creatinine in the blood plasma.

Disorders of the genital organs and breast: infrequently - vaginal bleeding.

General disorders and disorders at the injection site: very often - fatigue, drowsiness; often - peripheral edema, malaise, chest pain, fever, weakness, asthenia; Infrequently - swelling, chills, influenza like syndrome, trembling, fever.

Impact on the results of laboratory and instrumental studies: often - hyperbilirubinemia.

The following adverse reactions are manifestations of toxicity, known for therapy with fluoropyrimidines; At least an indirect association between the development of such reactions and the use of capecitabine was reported in less than 5% of patients who participated in 7 completed clinical studies (N = 949):

disorders of the gastrointestinal tract: dry mouth, flatulence, adverse reactions associated with inflammation / ulceration of the mucous membranes, such as esophagitis, gastritis, duodenitis, colitis, gastrointestinal bleeding;

cardiovascular disorders: edema of the lower extremities, cardialgia, including angina pectoris, cardiomyopathy, myocardial ischemia, myocardial infarction, heart failure, sudden death, tachycardia, supraventricular arrhythmias, including atrial fibrillation, ventricular extrasystoles;

nervous system disorders: taste disturbance, insomnia, confusion, encephalopathy, cerebellar symptoms (ataxia, dysarthria, imbalance and coordination);

mental disorders: depression;

infectious and parasitic diseases: infectious complications associated with myelosuppression, immunosuppression and / or mucositis, such as local and fatal systemic infections (bacterial, viral, or fungal etiology) and sepsis;

disorders of the blood and lymphatic system: anemia, myelosuppression / pancytopenia;

violations of the skin and subcutaneous tissues: itching, focal peeling of the skin, skin hyperpigmentation, changes in the nails, photosensitivity reactions, radiation dermatitis;

disorders of the organ of vision: eye irritation;

disorders of the respiratory system, organs of the chest and mediastinum: shortness of breath, cough;

disorders of the musculoskeletal and connective tissues: arthralgia, myalgia, back pain;

common disorders and disorders at the injection site: chest pain (non-cardiac etiology), pain in the extremities.

Capecitabine use in combination therapy

The safety profile did not differ when prescribed for various indications and with various combinations, but the adverse reactions listed in monotherapy can be observed with greater frequency when capecitabine is used in combination therapy.

Below are the adverse reactions that were observed in addition to those with monotherapy:

Infectious and parasitic diseases: often - candidiasis of the oral mucosa, herpes zoster, urinary tract infection, upper respiratory tract infection, rhinitis, influenza, infection, oral herpes;

Disorders of the blood and lymphatic system: very often - neutropenia, anemia, thrombocytopenia, leukopenia, febrile neutropenia; often - myelosuppression;

Immune system disorders: often - hypersensitivity;

Metabolism and nutrition disorders: very often - weight loss, loss of appetite; often - hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, hyperglycemia;

Mental disorders: often - sleep disorders, anxiety;

Nervous system disorders: very often - paresthesia, dysgeusia, headache, peripheral neuropathy, peripheral sensory neuropathy, dysesthesia; often - neurotoxicity, tremor, neuralgia, hypesthesia;

Disturbances from the organ of vision: very often - lacrimation; often - visual disturbances, dry eyes, pain in the eyes, blurred vision;

Disorders of the organ of hearing and labyrinth disorders: often - tinnitus, hearing loss;

Heart disorders: often - atrial fibrillation;

Vascular disorders: very often - thrombosis / embolism, high blood pressure (BP), lower extremity edema; often - hyperemia, lowering blood pressure, hypertensive crisis, "hot flashes", phlebitis;

Disturbances of the respiratory system, organs of the chest and mediastinum: very often - pharyngeal dysesthesia, sore throat; often - nosebleeds, dysphonia, rhinorrhea, hiccups, sore throat and larynx;

Violations of the gastrointestinal tract: very often - constipation, dyspepsia; often - bleeding from the upper gastrointestinal tract, oral ulcers, gastritis, bloating, gastroesophageal reflux disease, pain in the mouth, dysphagia, rectal bleeding, abdominal pain, dysesthesia, paresthesia and hypoesthesia in the mouth, abdominal discomfort;

Disorders of the liver and biliary tract: often - impaired liver function;

Violations of the skin and subcutaneous tissues: very often - alopecia, changing nails; often - hyperhidrosis, erythematous rash, urticaria, night sweats;

Disorders of the musculoskeletal and connective tissues: very often - myalgia, arthralgia, pain in the limbs; often - pain in the jaw, muscle spasms, trismus, muscle weakness;

Disorders of the kidneys and urinary tract: often - hematuria, proteinuria, decreased creatinine clearance, dysuria;

General disorders and disorders at the injection site: very often - weakness, lethargy, hypersensitivity to high and low temperatures; often - fever, pain, inflammation of the mucous membrane, chills, chest pain, flu-like syndrome, contusion.

Both in clinical studies and outside of them, cases of liver failure and cholestatic hepatitis were recorded. A causal relationship with capecitabine has not been established.

With capecitabine therapy in combination with other chemotherapy drugs, often (but less than 5% of patients) reported cases of hypersensitivity reactions (2%) and ischemia / myocardial infarction (3%).

Laboratory and instrumental data:

The following are changes in laboratory parameters observed in clinical trials in patients with adjuvant treatment of colon cancer and in patients with treatment of metastatic breast cancer and metastatic colorectal cancer, regardless of their relationship with capecitabine: neutropenia, granulocytopenia, lymphocytopenia, thrombocytopenia, anemia, hyperbilirubinemia, increased activity of ALT, AST, alkaline phosphatase, hypercreatininemia, hyperglycemia, hypo- / hypercalcemia, hyponatremia, hypoka iemiya.

Post-registration experience with capecitabine

rarely - acute renal failure as a result of dehydration, including fatal, point keratitis, ventricular fibrillation, lengthening of the QT interval, ventricular tachysystolic fibrin tina, pirouette, bradycardia, vasospasm; very rarely - cutaneous lupus erythematosus, severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, lacrimal tubular stenosis, unspecified, corneal lesion, including keratitis; very rarely, in clinical studies, cases of hepatic failure and cholestatic hepatitis were also recorded outside of their framework.

Diarrhea

Diarrhea was observed in 50% of patients during therapy with capecitabine. As a result of a meta-analysis of 14 clinical studies involving more than 4,700 patients receiving capecitabine therapy, covariates were identified that were statistically associated with an increased risk of developing diarrhea: an increase in the initial dose of capecitabine (in grams), an increase in the study period of treatment (in weeks), an increase in age of the patient (for every 10 years), female gender. Covariates, statistically associated with a decrease in the risk of developing diarrhea: an increase in the cumulative dose of capecitabine (0.1 kg) and an increase in the relative intensity of the dose in the first 6 weeks of treatment.

Patients with severe diarrhea should be carefully observed, conducting their rehydration and restoring the water-electrolyte balance during dehydration. According to the testimony, it is recommended to take standard antidiarrheal drugs (for example, loperamide) as early as possible.

Cardiotoxicity

In addition to the side effects presented in Tables 4 and 5, with monotherapy with capecitabine, the following adverse reactions were observed with a frequency of occurrence of less than 0.1%: cardiomyopathy, heart failure, sudden death and ventricular extrasystoles.

Encephalopathy

With monotherapy with capecitabine, encephalopathy was observed with a frequency of occurrence of less than 0.1%.

Adverse reactions in special patient groups

Elderly patients

Elderly patients aged> 60 years who received capecitabine as monotherapy or in combination with docetaxel showed an increase in the incidence of severity 3 and 4 severity and serious adverse reactions compared with patients aged <60 years="" most="" patients="" aged=""> 60 years who received the combination therapy with docetaxel showed an earlier cessation of treatment as a result of adverse reactions compared with patients aged <60 years="" as="" a="" result="" of="" meta-analysis="" 14="" clinical="" studies="" involving="" more="" than="" 4="" 700="" patients="" who="" received="" capecitabine="" it="" was="" found="" that="" with="" increasing="" patient="" age="" for="" every="" 10="" the="" risk="" developing="" palm-sole="" syndrome="" and="" diarrhea="" increases="" while="" neutropenia="" on="" contrary="" declined="" p="">

Floor

In female patients, there is a statistically significant increase in the risk of developing palm-sole syndrome and diarrhea, the risk of developing neutropenia is reduced.

Patients with impaired renal function

Patients with impaired renal function before treatment who received capecitabine monotherapy showed an increase in the incidence of adverse events of grade 3 and 4 associated with treatment compared with patients with normal renal function (36% in patients without renal dysfunction, 41% with mild renal insufficiency and 54% with moderate renal insufficiency). Patients with moderate renal failure more often needed to reduce the dose (44%) compared with 33 and 32% of patients without renal failure with mild renal insufficiency, respectively, and more often marked premature withdrawal of treatment.

- Hypersensitivity to capecitabine or any other components of the drug;

- hypersensitivity to fluorouracil or in cases of unexpected or severe adverse reactions to the treatment with a history of fluoropyrimidine derivatives;

- an established deficiency of DPD (dihydropyrimidine dehydrogenase), as well as for other fluoropyrimidines;

- simultaneous reception of sarivudin or its structural analogs of brivudin type;

- severe liver failure;

- severe renal failure (creatinine clearance below 30 ml / min);

- severe leukopenia;

- the initial content of neutrophils <1,5x109 / l and / or platelet <100x109 l="" p="">

- if there are contraindications to one of the drugs of combination therapy, it should not be used;

- pregnancy and lactation period;

- children's age (efficacy and safety of use have not been established).

Carefully:

With ischemic heart disease, anemia and angina in history, moderate renal insufficiency or liver failure, hypo-or hypercalcemia, diseases of the central and peripheral nervous system, diabetes mellitus and disorders of water and electrolyte balance, over the age of 60 years, simultaneous use with oral coumarin anticoagulants, hereditary lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Drug interactions

Coumarin Anticoagulants

In patients who took capecitabine concurrently with coumarin anticoagulants (warfarin and fenprocumon), impaired clotting rates and / or bleeding were reported several days or months from the start of capecitabine therapy, and in several cases within one month after termination.

In a study of drug interactions after a single injection of warfarin at a dose of 20 mg, capecitabine increased the AUC of S-warfarin by 57%, and the value of the international normalized ratio (INR) by 91%. In patients taking capecitabine and coumarin anticoagulants, it is necessary to carefully monitor clotting parameters (prothrombin time or INR), the dose of anticoagulant should be selected in accordance with these indicators.

CYP2C9 isoenzyme substrates

Special studies of drug interactions of capecitabine with other drugs metabolized by the cytochrome P450 CYP2C9 isoenzyme of the system have not been conducted. Caution should be exercised when applying capecitabine with these drugs.

Phenytoin

While taking capecitabine and phenytoin, an increase in plasma concentration of the latter was reported. There have been no special studies on the interactions interaction between capecitabine and phenytoin, however, it is assumed that the basis of the interaction mechanism is the suppression of the CYP2C9 isoenzyme under the influence of capecitabine (see above "Anticoagulants of the coumarin"). In patients receiving both phenytoin and capecitabine, it is necessary to regularly monitor the concentration of phenytoin in the plasma.

Antacids

When evaluating the pharmacokinetic parameters of capecitabine, when taken simultaneously with antacids containing aluminum hydroxide and magnesium hydroxide, a slight increase in the concentration of capecitabine and one of the metabolites (5'-DFUR) in plasma was noted. The three major metabolites of capecitabine (5’-DFUR, FU, and FBAL) were not affected by the studied agents.

Calcium folinate (leucovorin)

Calcium folinate does not affect the pharmacokinetic properties of capecitabine and its metabolites. However, it is possible to enhance the toxic effect of capecitabine due to the effect of calcium folinate on the pharmacodynamics of capecitabine.

Sorivudin and its analogues

The literature describes the clinically significant drug interaction of sarivudine and FU, which is based on the inhibitory effect of sarivudine on DPD. This interaction can lead to a fatal increase in the toxicity of fluoropyrimidines.Therefore, capecitabine should not be administered at the same time as sorivudine or its structural analogs of brivudine type. There should be at least a four-week interval between the end of therapy with sarivudine or its structural analogues (including brivudine) and the start of treatment with capecitabine.

Oxaliplatin

No clinically significant difference in the exposure of capecitabine or oxaliplatin metabolites (free platinum or total platinum) with the combined use of capecitabine and oxaliplatin, regardless of the presence of bevacizumab, was noted.

Bevacizumab

The clinically significant effect of bevacizumab on the pharmacokinetics of capecitabine, or its metabolites, is not marked.

Allopurinol

The interaction between allopurinol and FU was noted with a possible decrease in the efficiency of FU. Therefore, the simultaneous use of capecitabine and allopurinol should be avoided.

Interferon alfa

The maximum tolerated dose of capecitabine is 2000 mg / m2 per day while taking it with interferon alpha-2-alpha (3 million IU / m2 per day) compared with a dose of capecitabine 3000 mg / m2 per day with monotherapy.

Radiation therapy

The maximum tolerated dose of capecitabine in monotherapy with a standard dosing regimen is 3000 mg / m2, with combined use of colorectal cancer radiotherapy (with a continuous therapy or 5-day courses from Monday to Friday for 6 weeks) - 2000 mg / m2 in day.

Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and during breastfeeding.

During therapy with capecitabine and for at least 3 months after its termination, reliable contraceptive methods should be used. If pregnancy occurs during the period of treatment, the patient should be aware of the potential threat to the fetus.

Special instructions

Adverse reactions that limit the dose of the drug are diarrhea, abdominal pain, nausea, stomatitis, hand-foot syndrome.

It is necessary to conduct a thorough medical monitoring of the manifestations of toxicity in patients receiving capecitabine therapy.

Most adverse events are reversible and do not require the complete abolition of the drug, although it may be necessary to adjust the dose or temporary withdrawal of the drug.

Diarrhea: treatment with capecitabine can cause diarrhea, sometimes severe. Patients with severe diarrhea should be carefully observed, and with the development of dehydration it is necessary to rehydrate or replace electrolyte loss. Standard antidiarrheal drugs (such as loperamide) should be prescribed as soon as possible for medical reasons. According to the criteria of the National Cancer Institute of Canada (NCIC STS, version 2), grade 2 diarrhea is defined as an increase in stools up to 4-6 times a day or stools at night, a grade 3 diarrhea as an increase in stools up to 7-9 times a day or fecal incontinence and malabsorption syndrome, grade 4 diarrhea, such as an increase in stool up to 10 or more times a day, the appearance of visible blood in the stool, or the need for parenteral supportive therapy. If necessary, reduce the dose of capecitabine.

Dehydration: dehydration should be prevented or eliminated at the very beginning of occurrence. Dehydration can quickly develop in patients with anorexia, asthenia, nausea, vomiting, or diarrhea.

Dehydration can cause the development of acute renal failure, in some cases with a fatal outcome, especially in patients with impaired renal function at the time of initiation of therapy or if the patient takes capecitabine simultaneously with drugs with nephrotoxic effects.

With the development of dehydration grade 2 or higher, treatment with capecitabine should be immediately interrupted and rehydration. Treatment cannot be resumed until the completion of rehydration and the elimination or correction of the factors causing it.The dose of the drug should be modified in accordance with the recommendations for adverse events that led to dehydration.

Cardiotoxicity: The spectrum of cardiotoxicity in the treatment with capecitabine is similar to that of other fluoropyrimidines and includes myocardial infarction, angina pectoris, arrhythmias, cardiac arrest, heart failure, and ECG changes. These are not

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