Teysuno - tegafur / gimeracil / oteracil

PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED

What is Teysuno - tegafur / gimeracil / oteracil?

Teysuno is a medicine that contains the active substances tegafur, gimeracil and oteracil. It is available as white and brown capsules containing 15 mg of tegafur with 4.35 mg of gimeracil and 11.8 mg of oteracil, and as white capsules containing 20 mg of tegafur with 5.8 mg of gimeracil and 15.8 mg of oteracil.

What is Teysuno used for - tegafur / gimeracil / oteracil?

Teysuno is indicated in adults for the treatment of gastric cancer (stomach cancer). The medicine is given in combination with cisplatin (another anticancer medicine).
The medicine can only be obtained with a prescription.

How is Teysuno used - tegafur / gimeracil / oteracil?

Teysuno should only be prescribed by a specialist doctor experienced in treating cancer patients with anticancer medicines.
Teysuno is used in combination with cisplatin in a treatment cycle that is repeated every 4 weeks, starting on the day of cisplatin administration. The dose to be taken is calculated based on the active ingredient tegafur and the patient's body surface area (ie relative to the patient's height and weight). The recommended dose for one course of treatment is 25 mg / m2 twice a day. in the morning and in the evening, for three weeks, followed by 7 days of rest. The cycle is repeated every 4 weeks, even after cisplatin administration is stopped at the end of six cycles. Teysuno capsules are taken with water at least one "now before or after meals. For more information on the use of Teysuno, including how to take it in combination with cisplatin, please refer to the Summary of Product Characteristics (included in the EPAR).

How does Teysuno work - tegafur / gimeracil / oteracil?

The active substance in Teysuno, tegafur, is a cytotoxic medicine (a substance that kills actively dividing cells, such as cancer cells) belonging to the group 'antimetabolites'. Tegafur is a "prodrug" which is a medicine that, when administered into the body, changes into a chemical called 5-fluorouracil (5-FU).5-FU is an analogue of pyrimidine, a substance found in the genetic material of cells (DNA and RNA). In the body, 5-FU replaces pyrimidine and interferes with the enzymes involved in DNA synthesis, thus preventing cancer cells from growing until they are destroyed.
The other two active ingredients in Teysuno allow tegafur to be effective at low doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU and oteracil by reducing the activity of 5-FU in normal intestinal tissues of a non-natural nature. tumor.

How has Teysuno been studied - tegafur / gimeracil / oteracil?

The effects of Teysuno were first tested in experimental models before being studied in humans. In the main study, Teysuno was compared with the anticancer medicine 5-FU administered by infusion in 1,053 adults with advanced gastric cancer. Both medicines were given in combination with cisplatin. The main measure of effectiveness was how long the patients lived.

What benefit has Teysuno - tegafur / gimeracil / oteracil shown during the studies?

Treatment with Teysuno capsules was as effective as infusion therapy with 5-FU. Patients treated with Teysuno and cisplatin survived an average of 8.6 months compared with 7.9 months for patients treated with 5-FU and cisplatin.

What is the risk associated with Teysuno - tegafur / gimeracil / oteracil?

In patients treated with Teysuno in combination with cisplatin, the most frequent serious side effects (seen in more than 1 in 10 patients) are neutropenia (decrease in the number of neutrophils, a type of white blood cell), anemia (decrease in the number of red blood cells in the blood) and fatigue. For the full list of side effects reported with Teysuno, see the Package Leaflet.
Teysuno must not be used in people who may be hypersensitive (allergic) to the active substance or to any of the other ingredients. Teysuno must also not be used in the following patient groups:

  • patients taking another fluoropyrimidine medicine (a group of anticancer medicines to which Teysuno belongs) or who have had severe and unexpected reactions to fluoropyrimidines;
  • subjects with a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) and subjects who, in the last four weeks, have been treated with a medicine that inhibits this enzyme;
  • pregnant or breastfeeding women;
  • patients with severe forms of leukopenia, neutropenia or thrombocytopenia (low levels of white blood cells or platelets in the blood);
    patients with severe kidney problems;
    patients who are not recommended to use cisplatin.

Why has Teysuno - tegafur / gimeracil / oteracil been approved?

The CHMP decided that Teysuno's benefits are greater than its risks and recommended that it be given a Marketing Authorization for this medicine.

More information about Teysuno - tegafur / gimeracil / oteracil

On March 14, 2011, the European Commission granted Taiho Pharma Europe Limited a "Marketing Authorization" for Teysuno, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
Last update of this summary: 01-2011.


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