PLEASE NOTE: MEDICINAL PRODUCT IS 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 in the form of white capsules containing 20 mg of tegafur with 5.8 mg of gimeracil and 15.8 mg of oteracil.
What is Teysuno - tegafur / gimeracil / oteracil used for?
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 - tegafur / gimeracil / oteracil used?
Teysuno should only be prescribed by a specialist doctor who has experience in treating cancer patients with anticancer medicines.
Teysuno is used in combination with cisplatin in a repeated treatment cycle 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 (ie with respect to the patient's height and weight). The recommended dose for a treatment cycle is 25 mg / m2 twice a day, in the morning and 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 hour before or after meals. For more information on the use of Teysuno, including how to take it in combination with cisplatin, see the summary of product characteristics (also part of the EPAR).
How does Teysuno - tegafur / gimeracil / oteracil work?
The active substance in Teysuno, tegafur, is a cytotoxic medicine (a substance that kills cells in active division, such as cancer cells) belonging to the group of "antimetabolites". Tegafur is a "prodrug" that is a medicine that, once administered in the body, turns into a chemical called 5-fluorouracil (5-FU). 5-FU is an analogue of pyrimidine, a substance present in the genetic material of cells (DNA and RNA). In the body, 5-FU replaces pyrimidine and interferes with enzymes involved in DNA synthesis. In this way it prevents the growth of tumor cells until it is destroyed.
The other two active ingredients in Teysuno allow tegafur to be effective at low doses and with fewer undesirable effects: gimeracil preventing the breakdown of 5-FU and oteracil by reducing the activity of 5-FU in normal intestinal tissues of non nature tumor.
What studies have been performed on Teysuno - 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 to the 5-FU anticancer medicine given by infusion in 1 053 adults with advanced stage gastric cancer. Both medicines were given in combination with cisplatin. The main measure of effectiveness was the survival time of the patients.
What benefit has Teysuno - tegafur / gimeracil / oteracil shown during the studies?
Treatment with Teysuno capsules was as effective as 5-FU infusion therapy. Patients treated with Teysuno and cisplatin survived on average 8.6 months compared to 7.9 months in 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 patient in 10) 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 all side effects reported with Teysuno, see the Package Leaflet.
Teysuno should not be used in people who may be hypersensitive (allergic) to the active substance or to any of the other ingredients. In addition, Teysuno should not be used in the following groups of patients:
- patients treated with another fluoropyrimidine-based medicine (a group of anticancer medicines which also belongs to Teysuno) 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 nursing women;
- patients with severe forms of leukopenia, neutropenia or thrombocytopenia (low levels of white blood cells or platelets in the blood);
patients suffering from severe kidney problems;
patients who are advised against the use of 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 marketing authorization.
Other information on Teysuno - tegafur / gimeracil / oteracil
On March 14, 2011, the European Commission granted a marketing authorization valid for Teysuno, valid throughout the European Union, to Taiho Pharma Europe Limited. The marketing authorization is valid for five years, after which it can be renewed.
Last update of this summary: 01-2011.
