Ftorafur® [Tegafur]

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Available since: 2019-09-19

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Clinical Pharmacology

An antitumor drug whose action is due to a violation of the synthesis of DNA and RNA. The fluorouracil formed as a result of hydrolysis inhibits the enzyme thymidylate synthetase and DNA synthesis, is introduced into the structure of RNA instead of uracil, making it defective, and inhibits cell proliferation.

In tumor cells, it is converted into 5-fluoro-deoxyuridine-5-monophosphate, which is then phosphorylated into triphosphate and incorporated into RNA, and floxuridine monophosphate, which inhibits thymidylate synthetase. Less toxic and better tolerated by patients than 5-fluorouracil.

Pharmacokinetics

Suction

When ingested, tegafur is rapidly absorbed from the gastrointestinal tract and is found in the blood for at least 24 hours after a single dose. C_max plasma tegafur is reached within 4-6 hours after administration. Bioavailability is almost complete.

Distribution

It has a high lipophilicity (200 times higher than fluorouracil), while remaining a water-soluble compound. High lipophilicity ensures rapid passage through biological membranes, distribution in the body and penetration through the BBB.

Metabolism

Metabolized in the liver to form metabolites, among which pharmacologically active 5-fluorouracil is central. Bioactivation is carried out not only in the liver, but can also be local in tumor tissue, which is characterized by an increased content of cytosolic hydrolytic enzymes.

Indications

Cancer of the colon and rectum;
stomach cancer;
mammary cancer;
diffuse atopic dermatitis;
cutaneous lymphomas.

Composition

1 capsule contains:

Active substances: tegafur 400 mg.

Excipients: stearic acid.

The composition of the capsule shell: gelatin, titanium dioxide (E171), Quinoline yellow (E104), Ponceau 4R (E124).

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Dosage and Administration

Assign inside. The daily dose of the drug Ftorafur® is 800-1000 mg / m² (20-30 mg / kg body weight) in 2-4 doses, but not more than 2 g / day. Course dose when administered is 30-40 g. The interval between courses is 4 weeks. The dose of the drug Ftorafur® can be reduced in elderly patients and in the advanced stage of the disease.

Adverse reactions

From the hemopoietic system: leukopenia, thrombocytopenia, anemia.

From the digestive system: nausea, vomiting, anorexia, abdominal pain, diarrhea; rarely - stomatitis, esophagitis, ulcerative lesions of the gastrointestinal mucosa, gastrointestinal bleeding, abnormal liver function, acute hepatitis, acute pancreatitis.

From the side of the central nervous system: dizziness, confusion, drowsiness, ataxia, euphoria, symptoms of leukoencephalitis.

Since the cardiovascular system: cardialgia, stenocardia, myocardial ischemia, myocardial infarction.

From the senses: diplopia, lacrimation, fibrosis of the lacrimal ducts, loss of smell.

Dermatological reactions: alopecia, impaired regeneration of the skin, nails.

Other: pharyngitis, allergic reactions (including anaphylactic shock), impaired renal function, dehydration of the body, interstitial pneumonia.

Carefully: the drug should be used in patients with impaired blood formation, liver and kidney, glucose metabolism, with gastric ulcer and duodenal ulcer, a tendency to bleeding, with infectious diseases.

Drug interactions

With simultaneous use of the drug Ftorafur® and phenytoin, it is possible to enhance the effect of the latter.

Ftorafur® increases the effectiveness of other chemotherapeutic agents and radiation therapy (side effects are also enhanced). At simultaneous use with inhibitors of microsomal oxidation in the liver, the toxicity of the drug Ftorafur® increases.

Pregnancy and Lactation

Ftorafur® is contraindicated for use during pregnancy and lactation (breastfeeding).

It should be borne in mind that the drug inhibits the reproductive function of the patient.

Special instructions

If necessary, the appointment of the drug Ftorafur® patients with disorders of blood, liver and kidney, glucose metabolism, with gastric ulcer and duodenal ulcer, a tendency to hemorrhages, with infectious diseases should take into account the potential risk of adverse reactions. During the period of treatment, the picture of peripheral blood, the functional state of the liver and kidneys should be regularly monitored. With prolonged use of the drug its side effect increases.

Dizziness, nausea, and vomiting decrease with daily dose fractionation.

With the development of serious side effects, you must stop using the drug.

Use in Pediatrics

The safety of the drug in children has not been established.

Overdosage

Symptoms: increased toxic effects of the gastrointestinal tract, central nervous system and hematopoietic depression.

Treatment: monitoring of hematopoietic function for at least 4 weeks, if necessary, symptomatic therapy is carried out. The specific antidote to tegafur is unknown.