What is Jevtana - cabazitaxel?
Jevtana is a medicine that contains the active substance cabazitaxel. It is available as a concentrate and solvent for solution for intravenous infusion.
What is Jevtana used for?
Jevtana is used to treat men with hormone refractory metastatic prostate cancer. This cancer affects the prostate gland, a gland located under the male bladder that produces seminal fluid. Jevtana is used in cases where the cancer has spread to other parts of the body (metastatic) and no longer responds to hormone treatment (hormone refractory). It is used in combination with prednisone or prednisolone (anti-inflammatory drugs) in patients who have previously been treated with docetaxel (another anticancer medicine).
The medicine can only be obtained with a prescription.
How is Jevtana used - cabazitaxel?
Jevtana is to be used only in units specializing in chemotherapy (medicines for cancer treatment) under the supervision of a doctor with experience in the use of chemotherapy.
Jevtana is given once every three weeks as a one-hour infusion at a dose of 25 mg per square meter of body surface area (based on the patient's weight and height). It is given in combination with prednisone or prednisolone, which are taken at a daily dose during treatment. The dose of Jevtana should be reduced if the patient experiences side effects and treatment should be stopped if side effects persist at the reduced dose of 20 mg / m2.
Before Jevtana infusions, patients should be given anti-allergic medicines to reduce the risk of allergic reactions and anti-emetic medicines to prevent vomiting.
How does Jevtana - cabazitaxel work?
The active substance in Jevtana, cabazitaxel, belongs to the group of anticancer drugs known as "taxanes". Cabazitaxel inhibits the ability of cancer cells to break down their internal 'skeleton', which allows them to divide and multiply. By remaining intact this skeleton, the cells cannot divide and eventually die. Jevtana also acts on non-cancer cells, such as blood and nerve cells, causing side effects.
How has Jevtana been studied - cabazitaxel?
The effects of Jevtana were first tested in experimental models before being studied in humans.
Jevtana was studied in a pivotal study involving 755 men with hormone-refractory metastatic prostate cancer previously treated with docetaxel. The effects of Jevtana were compared with those of another anticancer medicine, mitoxantrone. Both drugs were administered in conjunction with the daily dose of prednisone or prednisolone. The main measure of effectiveness was overall survival (the average life span of patients).
What benefit has Jevtana - cabazitaxel shown during the studies?
In the main study, Jevtana prolonged overall survival compared to the comparator medicine mitoxantrone. The mean overall survival for patients treated with Jevtana was 15.1 months compared to 12.7 months for patients treated with mitoxantrone.
What are the risks associated with Jevtana - cabazitaxel?
The most frequent side effects with Jevtana (seen in more than 1 in 10 patients) are anemia (low number of red blood cells), leukopenia (low number of white blood cells), neutropenia (low number of neutrophils, a type of white blood cell), thrombocytopenia (low number of platelets) and diarrhea. For the full list of side effects reported with Jevtana, see the package leaflet.
Jevtana must not be used in people who are hypersensitive (allergic) to cabazitaxel, to other taxanes, or to any of the other ingredients. It must not be given to patients with blood neutrophils below 1,500 / mm3, who have abnormal liver test results indicating liver problems or who have recently been given a yellow fever vaccine or who are about to receive the vaccine. against yellow fever.
Why has Jevtana - cabazitaxel been approved?
The CHMP considered that Jevtana's ability to prolong overall survival in patients with hormone refractory metastatic prostate cancer was clinically relevant. The Committee therefore decided that Jevtana's benefits are greater than its risks and recommended that it be given marketing authorization.
More information about Jevtana - cabazitaxel
On March 17, 2011, the European Commission granted Sanofi-Aventis a "Marketing Authorization" for Jevtana, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which which can be renewed.
For more information about treatment with Jevtana, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03/2011.
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