Myocet

doxorubicin

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This is a summary of the European public assessment report (EPAR) for Myocet. 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 Myocet.

What is Myocet?

Myocet is a powder and solutions to be made up into a solution for infusion (drip) into a vein. It contains the active substance doxorubicin hydrochloride.

What is Myocet used for?

Myocet is used with cyclophosphamide (an anticancer medicine) for the treatment of metastatic breast cancer in adult women (aged 18 years or over). ‘Metastatic’ means that the cancer has spread to other parts of the body.

The medicine can only be obtained with a prescription.

How is Myocet used?

Myocet should be used in units specialised in giving cytotoxic chemotherapy (cell-killing cancer treatments) under the supervision of a doctor who is qualified in the use of chemotherapy. Myocet needs to be prepared before use by mixing the separate components supplied in the pack and using a special heater or a water bath.

Myocet is given every three weeks as an infusion into a vein lasting an hour. It must not be given into a muscle or under the skin, or as a ‘bolus’ injection (all at once). The patient’s liver and bone marrow should be monitored during treatment using blood tests. The doctor may decide to interrupt treatment or reduce the dose if signs of liver problems or other side effects develop.

How does Myocet work?

The active substance in Myocet, doxorubicin hydrochloride, is a cytotoxic (cell-killing) medicine that belongs to the group ‘anthracyclines’. It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins. This means that cancer cells cannot divide and eventually die. Myocet levels build up in tumours, so that the medicine’s action is concentrated there.

Doxorubicin hydrochloride has been available since the 1960s. In Myocet, doxorubicin hydrochloride is contained within microscopic fat particles called ‘liposomes’. This reduces its negative effects on the heart and the gut, making it less likely to cause side effects.

How has Myocet been studied?

Myocet has been studied in three main studies involving a total of 681 adult women with metastatic breast cancer. In the first study, Myocet was compared with standard (non-liposomal) doxorubicin, both in combination with cyclophosphamide, in 297 women. In the second study, Myocet alone was compared with standard doxorubicin alone in 224 women. The third study compared Myocet with epirubicin (another anthracycline), both in combination with cyclophosphamide, in 160 women. In all three studies, the main measure of effectiveness was the number of patients who had responded to treatment after six weeks.

What benefit has Myocet shown during the studies?

Myocet was as effective as the comparator medicines in all three studies.

In the first study, 43% of the patients receiving Myocet or standard doxorubicin in combination with cyclophosphamide responded to treatment. In the study of Myocet or standard doxorubicin alone, 26% of each group responded. In the third study, 46% of the patients taking Myocet in combination with cyclophosphamide responded to treatment, compared with 39% of those receiving epirubicin in combination with cyclophosphamide.

Patients receiving Myocet were less likely to experience heart problems than those receiving standard doxorubicin.

What is the risk associated with Myocet?

The most common side effects with Myocet (seen in more than 1 patient in 10) are neutropenic fever (fever associated with low levels of neutrophils, a type of white blood cell), infection, neutropenia (low levels of neutrophils), thrombocytopenia (low blood platelet counts), anaemia (low red-blood-cell counts), leucopenia (low white-blood-cell counts), loss of appetite, nausea (feeling sick) or vomiting, stomatitis (inflammation of the lining of the mouth) or mucositis (inflammation of the moist body surfaces), diarrhoea, alopecia (hair loss), asthenia (weakness), fever, pain and rigors (shaking chills). For the full list of all side effects reported with Myocet, see the package leaflet.

Myocet must not be used in people who are hypersensitive (allergic) to doxorubicin or any of the other ingredients.

Why has Myocet been approved?

The CHMP noted that Myocet has a lower risk of heart problems than conventional doxorubicin, while both medicines have similar levels of effectiveness. Therefore, the Committee decided that Myocet’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Myocet

The European Commission granted a marketing authorisation valid throughout the European Union for Myocet on 13 July 2000.

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

Name Language First published Last updated
Myocet : EPAR - Summary for the public BG = bălgarski 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public ES = español 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public CS = čeština 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public DA = dansk 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public DE = Deutsch 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public ET = eesti keel 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public EL = elliniká 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public EN = English 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public FR = français 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public IT = italiano 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public LV = latviešu valoda 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public LT = lietuvių kalba 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public HU = magyar 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public MT = Malti 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public NL = Nederlands 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public PL = polski 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public PT = português 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public RO = română 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public SK = slovenčina 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public SL = slovenščina 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public FI = suomi 2008-03-07 2013-01-25
Myocet : EPAR - Summary for the public SV = svenska 2008-03-07 2013-01-25

This EPAR was last updated on 13/03/2015 .

Authorisation details

Product details

Product details for Myocet
NameMyocet
Agency product numberEMEA/H/C/000297
Active substance

doxorubicin hydrochloride

International non-proprietary name (INN) or common name

doxorubicin

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L01DB01

Publication details

Publication details for Myocet
Marketing-authorisation holder

Teva B.V.

Revision19
Date of issue of marketing authorisation valid throughout the European Union13/07/2000

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

27/01/2015  Myocet -EMEA/H/C/000297 -T/0054

Name Language First published Last updated
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13
Myocet : EPAR - Product Information SV = svenska 2009-11-12 2015-03-13

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
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19
Myocet : EPAR - All Authorised presentations SV = svenska 2008-08-16 2012-06-19

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Myocet, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Myocet : EPAR - Procedural steps taken before authorisation SV = svenska 2008-08-16  
Myocet : EPAR - Scientific Discussion SV = svenska 2006-08-16  

Authorised

This medicine is approved for use in the European Union