Active Substance: cabazitaxel
Common Name: cabazitaxel
ATC Code: L01CD
Marketing Authorisation Holder: sanofi-aventis groupe
Active Substance: cabazitaxel
Authorisation Date: 2011-03-17
Therapeutic Area: Prostatic Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents
Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
What is Jevtana?
Jevtana is a cancer 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 Jevtana 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 cancer medicine).
The medicine can only be obtained with a prescription.
How is Jevtana 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, 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/m2. The doses should also be lower in patients with mildly or moderately reduced liver function.
Before receiving Jevtana infusions, patients should first be given anti-allergic medicines to reduce the risk of allergic reactions and anti-emetic medicines to prevent vomiting.
How does Jevtana 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 Jevtana 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 cancer 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 benefit has Jevtana 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 with Jevtana?
The most common side effects with Jevtana (seen in more than 1 patient in 10) include 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. Some of these effects were severe. 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/mm3, severely reduced liver function or who recently received or are about to receive a yellow-fever vaccine.
Why has Jevtana been approved?
The CHMP considered the ability of Jevtana to prolong overall survival in hormone-refractory metastatic prostate cancer patients to be clinically important. It decided that Jevtana’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 Jevtana?
A risk management plan has been developed to ensure that Jevtana is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jevtana, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Jevtana
The European Commission granted a marketing authorisation valid throughout the European Union for Jevtana on 17 March 2011.
For more information about treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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