Xalvobin (Tablets) Instructions for Use

ATC Code

L01BC06 (Capecitabine)

Active Substance

Capecitabine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antitumor drug. Antimetabolite

Pharmacotherapeutic Group

Antineoplastic agent, antimetabolite

Pharmacological Action

Antineoplastic agent. It exerts a selective cytotoxic effect. In tumor tissue, Capecitabine is converted to 5-fluorouracil under the action of thymidine phosphorylase (a tumor angiogenic factor).

The activity of thymidine phosphorylase in the primary tumor is 4 times higher than in healthy tissue, therefore 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 triphosphate, which exert a cytotoxic effect.

Indications

Locally advanced or metastatic breast cancer, after failure of chemotherapy containing paclitaxel and an anthracycline-containing drug, or when there are contraindications to anthracycline therapy.

ICD codes

Dosage Regimen

Take tablets orally within 30 minutes after a meal with water.

The standard dose for metastatic breast cancer is 1250 mg/m² administered twice daily (morning and evening).

Calculate the total daily dose using the patient’s body surface area. Divide this total daily dose into two equal administrations.

Administer treatment in 3-week cycles consisting of 2 weeks of treatment followed by a 1-week rest period.

Do not crush or split tablets.

Adjust the dose based on tolerance and toxicity, particularly for grade 2-4 adverse reactions.

For patients with a baseline bilirubin of 1.0-1.5 x ULN, reduce the starting dose to 75% (approximately 950 mg/m² twice daily).

Do not administer to patients with severe renal impairment (creatinine clearance below 30 mL/min).

Monitor patients frequently for toxicities such as diarrhea, nausea, vomiting, stomatitis, and hand-foot syndrome.

Interrupt therapy immediately for grade 2 or higher adverse events. Resume treatment at a reduced dose after symptoms resolve to grade 0-1.

Consult the full prescribing information for specific dose modification guidelines based on the observed toxicity grade.

Adverse Reactions

From the digestive system: diarrhea, nausea, vomiting, stomatitis, abdominal pain, constipation, epigastric pain, dyspepsia, dry mouth, flatulence, loose stools, anorexia, decreased appetite, oral candidiasis, hyperbilirubinemia, taste disturbance.

From the nervous system: increased fatigue, weakness, pronounced drowsiness, headache, paresthesia, dizziness, sleep disorders, asthenia.

From the skin and subcutaneous tissues: palmar-plantar erythrodysesthesia syndrome, dermatitis, dry skin, alopecia, pruritus, focal desquamation, skin hyperpigmentation, skin fissures.

Other: increased lacrimation, fever, possible dehydration, weight loss, possible dyspnea, cough, pain in the extremities, back pain, myalgia, cardiotoxic effect (most likely in patients with coronary artery disease), edema of the lower extremities, anemia.

Contraindications

History of severe unpredictable reactions when treated with fluoropyrimidine, hypersensitivity to capecitabine and 5-fluorouracil.

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies on the safety of capecitabine use during pregnancy have not been conducted. Experimental studies have shown that Capecitabine has fetotoxic and teratogenic effects. Use during pregnancy is not recommended. Women of childbearing potential should use reliable methods of contraception during treatment.

It is not known whether Capecitabine is excreted in breast milk. If use during lactation is necessary, the expected benefit of treatment for the mother and the existing risk for the child should be assessed.

Use in Hepatic Impairment

During treatment, patients with mild and moderate hepatic impairment due to liver metastases require careful medical supervision.

Pediatric Use

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

Geriatric Use

During treatment, elderly persons require careful medical supervision.

Special Precautions

During treatment, patients with mild and moderate hepatic impairment due to liver metastases and elderly persons require careful medical supervision.

In case of moderate or severe hyperbilirubinemia, administration of capecitabine should be temporarily discontinued until values return to mild severity.

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

Effect on ability to drive vehicles and operate machinery

Use with caution in patients engaged in potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of capecitabine with coumarin anticoagulants, coagulation parameters may be impaired and bleeding may develop (it is necessary to regularly monitor coagulation parameters).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.