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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/20503/2012

EMEA/H/C/001242

EPAR summary for the public

Teysuno

tegafur/gimeracil/oteracil

This is a summary of the European public assessment report (EPAR) for Teysuno. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Teysuno.

What is Teysuno?

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

What is Teysuno used for?

Teysuno is used to treat adults with advanced gastric (stomach) cancer. It is used in combination with cisplatin (another anticancer medicine).

The medicine can only be obtained with a prescription.

How is Teysuno used?

Teysuno should only be prescribed by a qualified doctor experienced in treating cancer patients with anticancer medicines.

Teysuno is used together with cisplatin, in a 4-week cycle starting on the day of the cisplatin administration. The dose to be taken is calculated based on the active substance tegafur and the patient's body surface area (calculated using the patient's height and weight). The recommended dose for one cycle of treatment is 25 mg/m² twice a day (in the morning and evening) for three weeks, followed by a one-week rest period. The cycle is repeated every four weeks, including once cisplatin administration is stopped after six cycles. Teysuno capsules are taken with water at least one hour

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before or after a meal. For more information on the use of Teysuno, including how to use it with cisplatin, see the summary of product characteristics (also part of the EPAR).

How does Teysuno work?

The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the 'anti-metabolites' group. Tegafur is a 'prodrug' that is converted in the body to a chemical called 5-fluorouracil (5-FU). 5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA). In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it prevents the growth of cancer cells and eventually kills them.

The two other active substances in Teysuno allow tegafur to be effective at lower 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, non-cancerous tissue in the gut.

How has Teysuno been studied?

In the main study, Teysuno was compared with the anticancer medicine 5-FU given as an infusion in 1,053 adults with advanced gastric cancer. Both medicines were given with cisplatin. The main measure of effectiveness was how long the patients lived.

What benefit has Teysuno shown during the studies?

Treatment with Teysuno capsules was as effective as treatment with 5-FU infusions. Patients receiving Teysuno with cisplatin lived for an average of 8.6 months compared with 7.9 months for patients receiving 5-FU with cisplatin.

What is the risk associated with Teysuno?

In patients treated with Teysuno in combination with cisplatin, the most common severe side effects (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts) and fatigue (tiredness). For the full list of all side effects reported with Teysuno, see the package leaflet.

Teysuno must not be used in people who are hypersensitive (allergic) to any of the active substances or any of the other ingredients. It must also not be used in the following groups:

•    patients currently receiving another fluoropyrimidine (a group of anticancer medicines that includes Teysuno) or who have had severe and unexpected reactions to fluoropyrimidines;

•    patients with a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) as well as patients who, within the previous four weeks, have been treated with a medicine that inhibits this enzyme;

•    pregnant or breast-feeding women;

•    patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);

•    patients with severe kidney problems requiring dialysis;

•    patients who should not be receiving cisplatin.

Why has Teysuno been approved?

The CHMP decided that Teysuno's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Teysuno

The European Commission granted a marketing authorisation valid throughout the European Union for Teysuno on 14 March 2011.

The full EPAR for Teysuno can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Teysuno, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2012.

Teysuno

EMA/20503/2012

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