Teysuno

tegafur / gimeracil / oteracil

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Teysuno is a cancer medicine. It belongs to a group of cancer medicines called fluoropyrimidines and is used to treat advanced gastric (stomach) cancer together with cisplatin (another cancer medicine). It is also used to treat metastatic colorectal cancer (cancer of the colon and rectum that has spread elsewhere in the body) in patients who can no longer be treated with other fluoropyrimidines because of unacceptable side effects. For this it may be used alone or with the cancer medicines oxaliplatin or irinotecan, with or without another medicine, bevacizumab.

Teysuno contains the active substances tegafur, gimeracil and oteracil.

: Teysuno should only be prescribed by a doctor who is experienced in the use of cancer medicines.
Before starting treatment, it is recommended that patients are tested to check whether they have a working dihydropyrimidine dehydrogenase (DPD) enzyme.
Teysuno 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. The recommended initial dose depends on the patient’s height and weight. Teysuno capsules should be taken at least one hour before or after a meal.
For the treatment of advanced gastric cancer, Teysuno is used in a four-week cycle starting on the day of cisplatin administration. The capsules are given twice daily for 21 days followed by a 7-day gap before the next course. Cisplatin treatment stops after six cycles, but Teysuno treatment is continued unless the disease gets worse or the side effects are unacceptable.
For the treatment of metastatic colorectal cancer, Teysuno is used in a three-week cycle, with capsules given twice daily for 14 days, followed by a 7-day gap before starting the next cycle. Bevacizumab can be given on day 1 of each cycle. If Teysuno is given in combination with oxaliplatin and irinotecan, a lower dose is recommended.
Doses need to be adjusted for patients with kidney disease and for patients who develop certain side effects. For patients with partial DPD deficiency, a lower starting dose may be considered.
For more information about using Teysuno, see the package leaflet or contact your doctor or pharmacist.

: The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills rapidly dividing cells, such as cancer cells). Tegafur is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.
Fluorouracil is very similar to pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it prevents the growth of tumour 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 fluorouracil and oteracil by reducing the activity of fluorouracil in normal, non-cancerous tissue in the gut.

: Gastric cancer
Teysuno has been shown to be as effective as fluorouracil in the treatment of advanced gastric cancer in clinical trials. In a main study, Teysuno was compared with the cancer medicine fluorouracil 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.
Treatment with Teysuno capsules was as effective as treatment with fluorouracil infusions. Patients receiving Teysuno with cisplatin lived for an average of 8.6 months compared with 7.9 months for patients receiving fluorouracil with cisplatin.
Colorectal cancer
The company presented results from retrospective cohort studies in which Teysuno was used to treat metastatic colorectal cancer, after patients had experienced unacceptable side effects with other fluoropyrimidine-based treatments. In addition, the company provided a review and analysis of studies from the scientific literature in which Teysuno treatment was compared to other fluoropyrimidines for the treatment of metastatic colorectal cancer. In total, 1,062 patients treated with Teysuno-based therapies and 1,055 patients who were treated with other fluoropyrimidine-based treatments were included in this analysis. The analysis showed that both the time patients lived without their disease worsening and the time patients lived overall were comparable between patients treated with Teysuno and patients treated with other medication.

In patients with advanced gastric cancer treated with Teysuno in combination with cisplatin, the most common severe side effects (which may affect 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).

In patients with metastatic colorectal cancer, side effects appear similar to those seen in patients treated for advanced gastric cancer.

Teysuno must 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 fluoropyrimidine therapy;
patients known to have no DPD enzyme activity, as well as patients who, within the previous four weeks, have been treated with a medicine that blocks this enzyme;
pregnant or breastfeeding 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, oxaliplatin, irinotecan or bevacizumab.

For the full list of all side effects and restrictions of Teysuno, see the package leaflet.

: Teysuno, in combination with cisplatin, has been shown to be effective in treating gastric cancer, and analysis of the literature has shown Teysuno-based treatments to be effective for metastatic colorectal cancer in patients for whom other fluoropyrimidine-based regimens are not an option because of side effects. The safety profile of the medicine is considered acceptable. The European Medicines Agency therefore decided that Teysuno’s benefits are greater than its risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Teysuno have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Teysuno are continuously monitored. Side effects reported with Teysuno are carefully evaluated and any necessary action taken to protect patients.

: Teysuno received a marketing authorisation valid throughout the EU on 14 March 2011.

List item

Teysuno : EPAR - Medicine overview (PDF/150.76 KB)

First published: 30/03/2011
Last updated: 28/02/2022
EMA/376940/2020
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- Swedish
  (PDF/147.21 KB)

This EPAR was last updated on 04/04/2022

Authorisation details

Product details
Name	Teysuno
Agency product number	EMEA/H/C/001242
Active substance	tegafur gimeracil oteracil
International non-proprietary name (INN) or common name	tegafur gimeracil oteracil
Therapeutic area (MeSH)	Stomach Neoplasms
Anatomical therapeutic chemical (ATC) code	L01BC53

Publication details
Marketing-authorisation holder	Nordic Group B.V.
Revision	21
Date of issue of marketing authorisation valid throughout the European Union	14/03/2011
Contact address	Siriusdreef 41 NL-2132 WT Hoofddorp The Netherlands

Product information

24/01/2022 Teysuno - EMEA/H/C/001242 - II/0045

List item

Teysuno : EPAR - Product Information (PDF/744.82 KB)

First published: 30/03/2011
Last updated: 28/02/2022
- Bulgarian
  (PDF/840.65 KB)
- Croatian
  (PDF/731.93 KB)
- Czech
  (PDF/780.24 KB)
- Danish
  (PDF/930.03 KB)
- Dutch
  (PDF/721.11 KB)
- Estonian
  (PDF/734.09 KB)
- Finnish
  (PDF/761.3 KB)
- French
  (PDF/783.05 KB)
- German
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- Hungarian
  (PDF/885.39 KB)
- Icelandic
  (PDF/716.76 KB)
- Italian
  (PDF/732.75 KB)
- Latvian
  (PDF/829.32 KB)
- Lithuanian
  (PDF/812.13 KB)
- Maltese
  (PDF/963.02 KB)
- Norwegian
  (PDF/712.47 KB)
- Polish
  (PDF/820.49 KB)
- Portuguese
  (PDF/738.2 KB)
- Romanian
  (PDF/850.39 KB)
- Slovak
  (PDF/806.3 KB)
- Slovenian
  (PDF/780.86 KB)
- Spanish
  (PDF/724.46 KB)
- Swedish
  (PDF/700.19 KB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Teysuno : EPAR - All Authorised presentations (PDF/22.33 KB)

First published: 30/03/2011
Last updated: 17/08/2012
- Bulgarian
  (PDF/57.93 KB)
- Czech
  (PDF/43.95 KB)
- Danish
  (PDF/35.59 KB)
- Dutch
  (PDF/35.61 KB)
- Estonian
  (PDF/17.74 KB)
- Finnish
  (PDF/64.29 KB)
- French
  (PDF/35.92 KB)
- German
  (PDF/35.74 KB)
- Greek
  (PDF/58.26 KB)
- Hungarian
  (PDF/32.67 KB)
- Icelandic
  (PDF/20.07 KB)
- Italian
  (PDF/35.89 KB)
- Latvian
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- Lithuanian
  (PDF/43.96 KB)
- Maltese
  (PDF/50.56 KB)
- Norwegian
  (PDF/19.01 KB)
- Polish
  (PDF/70.87 KB)
- Portuguese
  (PDF/52.65 KB)
- Romanian
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- Slovak
  (PDF/42.64 KB)
- Slovenian
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- Spanish
  (PDF/35.67 KB)
- Swedish
  (PDF/65.12 KB)

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Teysuno is indicated in adults:
- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).
- as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.

Assessment history

Changes since initial authorisation of medicine

List item

Teysuno : EPAR - Procedural steps taken and scientific information after authorisation (PDF/212.38 KB)

First published: 08/11/2011
Last updated: 28/02/2022
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Teysuno-H-C-001242-II-0045 : EPAR - Assessment Report - Variation (PDF/5.62 MB)

Adopted

First published: 04/04/2022
EMA/CHMP/2190/2022
List item

CHMP post-authorisation summary of positive opinion for Teysuno (II-45) (PDF/130.44 KB)

Adopted

First published: 17/12/2021
EMA/CHMP/714788/2021
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Teysuno-H-C-1242-A31-0040 : EPAR - Assessment Report - Article 31 (PDF/983.27 KB)

Adopted

First published: 30/07/2020
EMA/274404/2020
List item

Teysuno-H-C-1242-A31-0040 : EPAR - Scientific conclusions (PDF/153.51 KB)

Adopted

First published: 30/07/2020
- Bulgarian
  (PDF/153.84 KB)
- Croatian
  (PDF/159.55 KB)
- Czech
  (PDF/160.26 KB)
- Danish
  (PDF/151.3 KB)
- Dutch
  (PDF/144.7 KB)
- Estonian
  (PDF/146.06 KB)
- Finnish
  (PDF/142.69 KB)
- French
  (PDF/155.05 KB)
- German
  (PDF/151.35 KB)
- Greek
  (PDF/155.31 KB)
- Hungarian
  (PDF/156.62 KB)
- Icelandic
  (PDF/152.16 KB)
- Italian
  (PDF/149.57 KB)
- Latvian
  (PDF/172.71 KB)
- Lithuanian
  (PDF/170.51 KB)
- Maltese
  (PDF/179.14 KB)
- Norwegian
  (PDF/141.47 KB)
- Polish
  (PDF/148.76 KB)
- Portuguese
  (PDF/153.64 KB)
- Romanian
  (PDF/158.9 KB)
- Slovak
  (PDF/167.72 KB)
- Slovenian
  (PDF/158.32 KB)
- Spanish
  (PDF/151.95 KB)
- Swedish
  (PDF/141.88 KB)
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Teysuno-H-C-PSUSA-00002875-201601 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/66.59 KB)

First published: 24/11/2016
Last updated: 24/11/2016
EMA/789496/2016
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Teysuno-H-C-PSUSA-00002875-201501 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/69.51 KB)

First published: 29/01/2016
Last updated: 29/01/2016
EMA/CHMP/692100/2015
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Teysuno-H-C1242-II-0018 : EPAR - Assessment Report - Variation (PDF/321.11 KB)

Adopted

First published: 12/02/2015
Last updated: 12/02/2015
EMA/CHMP/641866/2014
List item

CHMP post-authorisation positive summary of opinion for Teysuno (PDF/50.54 KB)

Adopted

First published: 16/12/2011
Last updated: 16/12/2011
EMA/796457/2011

Teysuno

Table of contents

Overview

Teysuno : EPAR - Medicine overview (PDF/150.76 KB)

Authorisation details

Product information

Teysuno : EPAR - Product Information (PDF/744.82 KB)

Teysuno : EPAR - All Authorised presentations (PDF/22.33 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Teysuno : EPAR - Procedural steps taken and scientific information after authorisation (PDF/212.38 KB)

Teysuno-H-C-001242-II-0045 : EPAR - Assessment Report - Variation (PDF/5.62 MB)

CHMP post-authorisation summary of positive opinion for Teysuno (II-45) (PDF/130.44 KB)

Teysuno-H-C-1242-A31-0040 : EPAR - Assessment Report - Article 31 (PDF/983.27 KB)

Teysuno-H-C-1242-A31-0040 : EPAR - Scientific conclusions (PDF/153.51 KB)

Teysuno-H-C-PSUSA-00002875-201601 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/66.59 KB)

Teysuno-H-C-PSUSA-00002875-201501 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/69.51 KB)

Teysuno-H-C1242-II-0018 : EPAR - Assessment Report - Variation (PDF/321.11 KB)

CHMP post-authorisation positive summary of opinion for Teysuno (PDF/50.54 KB)

Initial marketing-authorisation documents

Teysuno : EPAR - Public assessment report (PDF/1.25 MB)

CHMP summary of positive opinion for Teysuno (PDF/118.1 KB)

News

More information on Teysuno

External links

Direct healthcare professional communications (DHPC)

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