How should it be stored?
Keep out of the reach and sight of children.

Do not use JEVTANA after the expiry date which is stated on the outer carton and on the label of the vials after EXP. The expiry date refers to the last day of that month.

Do not refrigerate.

Information about storage and the time to use JEVTANA, once it has been diluted and is ready to use, are described in the section “practical information for handling and administration“.

Any unused product or waste material should be disposed of in accordance with local requirements. These measures will help to protect the environment.

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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 ha