For doctors

What is it?

Jevtana is a medicine that contains the active substance cabazitaxel. It is available as a concentrate and a solvent to be made up into a solution for infusion (drip into a vein).

What is it used for?

Jevtana is used to treat men with hormone refractory metastatic prostate cancer. This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in semen. Jevtana is used when the cancer has spread to other parts of the body (metastatic) and has stopped responding to hormonal treatment (hormone refractory). It is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another anticancer medicine).

The medicine can only be obtained with a prescription.

How is it used?

Jevtana should only be used in units specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor experienced in the use of chemotherapy.

Jevtana is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient’s weight and height). It is given in combination with prednisone or prednisolone, which are taken daily throughout treatment. The dose of Jevtana should be reduced if the patient experiences certain side effects, and treatment should be stopped if side effects continue at a reduced dose of 20 mg/m .

Before receiving Jevtana infusions, patients should first be given anti-allergic medicines to reduce the risk of allergic reactions and antiemetic medicines to prevent vomiting.

How does it work?

The active substance in Jevtana, cabazitaxel, belongs to the group of anticancer medicines known as ‘taxanes’. Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton’ that allows them to divide and multiply. With their skeleton still in place, the cells cannot divide and they eventually die. Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.

How has it been studied?

The effects of Jevtana were first tested in experimental models before being studied in humans.

Jevtana was investigated in one main study involving 755 men with hormone refractory metastatic prostate cancer who had previously been treated with docetaxel. The effects of Jevtana were compared with another anticancer medicine, mitoxantrone. Both medicines were given in combination with daily prednisone or prednisolone. The main measure of effectiveness was overall survival (the average length of time the patients lived).

What benefits has 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.

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.