Capecitabine

Apsibin film-coated tablets are indicated for the treatment of:

Breast cancer:

• local widespread or metastatic breast cancer, in combination with docetaxel after ineffective chemotherapy, including anthracycline drugs;
• local widespread or metastatic breast cancer, with the ineffectiveness of chemotherapy, including taxanes and anthracycline drugs, or if there is a contraindication to anthracycline therapy.

Colorectal cancer, colorectal cancer:

• colon cancer, in adjuvant therapy
• first-line drug for the treatment of colorectal cancer with metastases.

Cancer of the esophagus and stomach. First-line drug for the treatment of common cancer of the esophagus and stomach.

Structure

Active ingredient: сapecitabine;

1 tablet contains - 150 mg capecitabine;

Excipients: croscarmellose sodium, microcrystalline cellulose (Avicel PH112), hypromellose (6 cps), lactose DCL22, magnesium stearate, opadra pink 03A540004 (hypromellose, titanium dioxide (E 171), talc, iron oxide red (E172), iron oxide (E172)) - for tablets of 150 mg, opadra pink 03A540003 (hypromellose, titanium dioxide (E 171), talc, iron oxide red (E172), iron oxide yellow (E172)) - for tablets of 500 mg.

Contraindications

Severe, including unexpected, reactions to treatment with fluoropyrimidines. Hypersensitivity to capecitabine or to any component of the drug, or fluorouracil. Known dihydropyrimidine dehydrogenase deficiency. Severe leukopenia, neutropenia, thrombocytopenia. Severe impairment of liver function. Severe renal failure (creatinine clearance <30 ml / min). Simultaneous administration of sorivudine or its structural analogues such as brivudine.

Mode of application

The drug is taken orally, not later than 30 minutes after a meal, washed down with water.

Dosage and administration.

standard dosage

The drug is taken orally, not later than 30 minutes after a meal, washed down with water.

Monoteratia. Colorectal cancer, colorectal cancer and breast cancer The recommended daily dose of capecitabine is 2500 mg / m2 and is applied in three-week cycles; take daily for 2 weeks, after which take a week break. The total daily dose of capecitabine is divided into two doses (1250 mg / m2 in the morning and evening).

Application features

Pregnant women

Not assigned.

Children

Not assigned.

Drivers

Not assigned.

Overdose

Symptoms of acute overdose: nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. The treatment is symptomatic.

Side effects

The most frequent and / or clinically significant adverse reactions associated with treatment were reactions from the digestive tract (diarrhea, nausea, vomiting, abdominal pain, stomatitis), palmar-plantar syndrome (palmar-plantar erythrodiesesthesia), weakness, asthenia, anorexia , cardiotoxicity, progression of impaired renal function in patients with renal failure, thrombosis / embolism.

Interaction

Coumarin anticoagulants. Capecitabine enhances the effects of indirect anticoagulants (warfarin and fenprocoumone), which can lead to a disruption of coagulation and bleeding several days or months after the start of capecitabine therapy, and in some cases, within one month after the end of treatment. In patients who simultaneously take capecitabine and oral anticoagulants - coumarin derivatives, it is necessary to conduct detailed monitoring of blood coagulation indicators (INR or prothrombin time) and select the dose of anticoagulant.

Storage conditions

Store in the original packaging out of the reach of children at a temperature not exceeding 25 ° C.

Shelf life is 3 years.