Capecitabin-Promomed (Tablets) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

ATC Code

L01BC06 (Capecitabine)

Active Substance

Capecitabine (Rec.INN WHO registered)

Dosage Forms

	Capecitabine-Promomed	Film-coated tablets, 150 mg: 60 pcs.
		Film-coated tablets, 500 mg: 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light orange in color, oval, biconvex; the core on the cross-section is white to almost white.

Excipients: anhydrous lactose – 17.6 mg, microcrystalline cellulose – 9.5 mg, croscarmellose sodium – 9.5 mg, hypromellose – 1.5 mg, magnesium stearate – 1.9 mg.

Film coating Opadry^® II 32F230021 light orange – 5 mg [hypromellose – 34%, lactose monohydrate – 28%, macrogol (polyethylene glycol 4000) -12%, titanium dioxide – 24.46%, sunset yellow aluminum lake – 1.51%, iron oxide black – 0.03%].

10 pcs. – contour cell packs (6) – cardboard packs.
60 pcs. – jars – cardboard packs.

Film-coated tablets orange in color, oval, biconvex; the core on the cross-section is white to almost white.

Excipients: anhydrous lactose – 41.9 mg, microcrystalline cellulose – 31 mg, croscarmellose sodium – 31 mg, hypromellose – 9.9 mg, magnesium stearate – 6.2 mg.

Film coating Opadry^® II 32F230022 orange – 18 mg [hypromellose – 34%, lactose monohydrate – 28%, macrogol (polyethylene glycol 4000) -12%, titanium dioxide – 19.42%, sunset yellow aluminum lake – 6.56%, ponceau 4R aluminum lake – 0.02%].

10 pcs. – contour cell packs (12) – cardboard packs.
60 pcs. – jars – cardboard packs.
120 pcs. – jars – cardboard packs.

Clinical-Pharmacological Group

Antitumor drug. Antimetabolite

Pharmacotherapeutic Group

Antineoplastic agents; antimetabolites; pyrimidine analogues

Pharmacological Action

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

The activity of thymidine phosphorylase 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 triphosphate, which have a cytotoxic effect.

Indications

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

ICD codes

Dosage Regimen

Calculate the total daily dose based on body surface area. The recommended starting dose is 2500 mg/m² per day, administered orally in two divided doses approximately 12 hours apart.

Take tablets within 30 minutes after the end of a meal with water. Do not crush or split tablets.

Administer treatment in 3-week cycles: two weeks of continuous treatment followed by a one-week rest period. Continue treatment for as long as clinical benefit is observed or until unacceptable toxicity occurs.

Adjust doses for toxicity based on laboratory parameters and clinical manifestations. For Grade 2 adverse reactions, interrupt therapy until resolved to Grade 0-1, then resume at the same dose.

For Grade 3 adverse reactions, interrupt therapy until resolved to Grade 0-1, then resume at a reduced dose of 75% of the original dose. For subsequent Grade 3 events, further reduce the dose to 50% of the original dose.

Discontinue therapy permanently upon the fourth occurrence of a Grade 3 event or the first occurrence of any Grade 4 adverse reaction.

Monitor patients with mild to moderate hepatic impairment due to liver metastases closely. No dose adjustment is recommended for patients with mild hepatic impairment; use caution in patients with moderate hepatic impairment.

Monitor elderly patients closely due to a higher incidence of Grade 3 or 4 adverse reactions. Adjust dose based on toxicity.

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 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), lower limb edema, 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, capecitabine intake 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 of attention and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of capecitabine with coumarin anticoagulants, blood clotting 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 30°C (86°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.