Cabecin (Tablets) Instructions for Use

ATC Code

L01BC06 (Capecitabine)

Active Substance

Capecitabine

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 by 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 cytotoxic effects.

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

Determine the dose individually based on body surface area, clinical indication, and patient tolerance.

For metastatic breast cancer, the recommended starting dose is 1250 mg/m² administered twice daily (morning and evening).

Take tablets within 30 minutes after a meal with water.

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

Do not crush or split tablets.

Adjust the dose for toxicity based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) grade.

For Grade 2 toxicities (first appearance), interrupt therapy until resolved to Grade 0-1, then resume at 100% of the original dose.

For Grade 2 toxicities (second appearance), interrupt therapy until resolved to Grade 0-1, then resume at 75% of the original dose.

For Grade 2 toxicities (third appearance), interrupt therapy until resolved to Grade 0-1, then resume at 50% of the original dose.

For Grade 3 toxicities (first appearance), interrupt therapy until resolved to Grade 0-1, then resume at 75% of the original dose.

For Grade 3 toxicities (second appearance), interrupt therapy until resolved to Grade 0-1, then resume at 50% of the original dose.

For Grade 4 toxicities, interrupt therapy immediately; consider discontinuation or resume at 50% of the original dose only after resolution to Grade 0-1.

Monitor patients with mild to moderate renal impairment (creatinine clearance 30-50 mL/min) closely; a dose reduction to 75% of the starting dose is recommended.

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

Adverse Reactions

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.

Nervous system: increased fatigue, weakness, pronounced drowsiness, headache, paresthesia, dizziness, sleep disorders, asthenia.

Skin and subcutaneous tissues: palmar-plantar erythrodysesthesia syndrome, dermatitis, dry skin, alopecia, itching, focal desquamation, skin hyperpigmentation, skin fissures.

Other: increased lacrimation, fever, possible dehydration, weight loss, possible dyspnea, cough, limb pain, 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 a 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 to 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 to 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.