s it shown during the studies?
In the main study, Jevtana prolonged overall survival compared with the comparator medicine mitoxantrone. The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.
What is the risk associated?
The most common side effects with Jevtana (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea. For the full list of all side effects reported with Jevtana, see the package leaflet.
Jevtana should not be used in people who may be hypersensitive (allergic) to cabazitaxel, to any other taxane, or to any of the other ingredients. It must not be given to patients whose blood neutrophil count is below 1,500/mm , who have abnormal liver test results indicating liver problems or who recently received or are about to receive a yellow fever vaccine.
Why has it been approved?
The CHMP considered that the ability of Jevtana to prolong overall survival in hormone refractory metastatic prostate cancer patients was clinically important. It decided that Jevtana’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Jevtana to Sanofi-Aventis on 17 March 2011. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in 03-2011.
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Name
JEVTANA 60 mg concentrate and solvent for solution for
infusion
Composition
One ml of concentrate contains 40 mg cabazitaxel.
Each vial of 1.5 ml of concentrate contains 60 mg cabazitaxel.
After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel.
Excipients:
Each vial of solvent contains 573.3 mg of ethanol 96%.
For the full list of excipients, see section 6.1.
Pharmaceutical Form
Concentrate and solvent for solution for infusion (sterile concentrate).
The concentrate is a clear yellow to brownish-yellow oily solution.
The solvent is a clear and colourless solution.
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