Torisel

temsirolimus

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This is a summary of the European public assessment report (EPAR) for Torisel. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Torisel.

For practical information about using Torisel, patients should read the package leaflet or contact their doctor or pharmacist.

What is Torisel and what is it used for?

Torisel is a medicine used to treat patients with the following types of cancer:

  • advanced renal cell carcinoma (a kidney cancer). ‘Advanced’ means that the cancer has started to spread;
  • mantle cell lymphoma (a cancer of B cells, a type of white blood cell). Torisel is used in adults when the lymphoma has come back after previous treatment or if other treatments have not worked.

Because the numbers of patients with renal cell carcinoma and mantle cell lymphoma are low, the diseases are considered ‘rare’, and Torisel was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 6 April 2006 (for renal cell carcinoma) and on 6 November 2006 (for mantle cell lymphoma).

Torisel contains the active substance temsirolimus.

How is Torisel used?

Torisel must be given under the supervision of a doctor who has experience in the use of cancer medicines. The medicine can only be obtained with a prescription.

Torisel is available as a concentrate and solvent that are made up into a solution for infusion (drip) into a vein. It is given as an infusion lasting 30 to 60 minutes. For renal cell carcinoma, the recommended dose of Torisel is 25 mg once a week, but a 10‑mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood. For mantle cell lymphoma, the recommended dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.

Patients are given an antihistamine injection to prevent an allergic reaction around 30 minutes before each dose of Torisel. Treatment with Torisel should continue until the medicine is no longer working or causes unacceptable side effects. Some side effects can be managed by interrupting treatment or reducing the dose.

How does Torisel work?

The active substance in Torisel, temsirolimus, is a cancer medicine, which blocks a protein called ‘mammalian target of rapamycin’ (mTOR). In the body, temsirolimus attaches to a protein inside cells to make a ‘complex’. This complex then blocks mTOR. Since mTOR is involved in the control of cell division, Torisel prevents the division of cancer cells, slowing down the growth and spread of the cancer.

What benefit of Torisel have been shown in studies?

In advanced renal cell carcinoma, a main study involving 626 patients with poor prognosis found Torisel more effective than interferon alfa (another medicine used in the treatment of cancer) at prolonging patients’ survival. Patients were treated with 25 mg Torisel, with interferon alfa or with 15 mg Torisel in combination with interferon alfa. Patients receiving Torisel alone survived 10.9 months on average compared with 7.3 months in those receiving interferon alfa alone. Patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar time (8.4 months) as those taking interferon alfa alone.

In mantle cell lymphoma, Torisel was found more effective than alternative cancer medicines (such as gemcitabine or fludarabine) in a main study involving 162 patients whose disease had come back after previous treatment or in whom other treatments had not worked. Each patient received one of two doses of Torisel or the most appropriate alternative cancer medicines chosen by the investigator. The main measure of effectiveness was how long patients lived without the disease getting worse. Patients receiving Torisel lived for 4.8 months on average without their disease getting worse compared with 1.9 months in those receiving the alternative treatment.

What are the risks associated with Torisel?

The most common side effects with Torisel (which may affect more than 1 in 5 patients) include infections, pneumonia (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), dysgeusia (taste disturbances), difficulty breathing, nose bleeds, cough, vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), rash, pruritus (itching), oedema (swelling), tiredness, weakness, fever and mucosal inflammation (inflammation of moist body surfaces).

The most serious side effects of Torisel are allergic (hypersensitivity) reactions, serious reactions that occur during the infusion or soon afterwards, infections, lung disorders including pneumonitis (inflammation of the lungs) and pulmonary embolism (blood clot in the lung), bleeding in the brain, kidney failure, tearing (perforation) of the intestine, complications affecting the healing of wounds, hyperglycaemia (high blood sugar), thrombocytopenia (low levels of platelets), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and hyperlipaemia (high blood levels of a type of fat).

For the full list of all side effects reported with Torisel, see the package leaflet.

Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine. Torisel is not recommended in patients with mantle cell lymphoma who have moderate or severe problems with their liver.

Why is Torisel approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Torisel’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Torisel?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Torisel have been included in the summary of product characteristics and the package leaflet.

Other information about Torisel

The European Commission granted a marketing authorisation valid throughout the European Union for Torisel on 19 November 2007.

For more information about treatment with Torisel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Torisel can be found on the Agency’s website.

Name Language First published Last updated
Torisel : EPAR - Summary for the public BG = bălgarski 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public ES = español 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public CS = čeština 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public DA = dansk 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public DE = Deutsch 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public ET = eesti keel 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public EL = elliniká 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public EN = English 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public FR = français 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public IT = italiano 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public LV = latviešu valoda 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public LT = lietuvių kalba 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public HU = magyar 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public MT = Malti 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public NL = Nederlands 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public PL = polski 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public PT = português 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public RO = română 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public SK = slovenčina 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public SL = slovenščina 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public FI = suomi 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public SV = svenska 2009-09-22 2017-08-07
Torisel : EPAR - Summary for the public HR = Hrvatski 2009-09-22 2017-08-07

This EPAR was last updated on 07/08/2017 .

Authorisation details

Product details

Product details for Torisel
NameTorisel
Agency product numberEMEA/H/C/000799
Active substance

temsirolimus

International non-proprietary name (INN) or common name

temsirolimus

Therapeutic area Carcinoma, Renal CellLymphoma, Mantle-Cell
Anatomical therapeutic chemical (ATC) code L01XE09
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Torisel
Marketing-authorisation holder

Pfizer Limited

Revision26
Date of issue of marketing authorisation valid throughout the European Union19/11/2007

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

13/07/2017  Torisel -EMEA/H/C/000799 -R/0065

Name Language First published Last updated
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07
Torisel : EPAR - Product Information HR = Hrvatski 2009-09-22 2017-08-07

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07
Torisel : EPAR - All Authorised presentations HR = Hrvatski 2007-12-05 2017-08-07

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Renal-cell carcinoma

Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.

Mantle-cell lymphoma

Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Torisel : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2007-12-05 2010-12-03
Torisel : EPAR - Scientific Discussion HR = Hrvatski 2007-12-05  

Authorised

This medicine is approved for use in the European Union

News

More information on Torisel