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 - cabazitaxel used for?
Jevtana is used to treat men with hormone refractory metastatic prostate cancer. This carcinoma affects the prostate gland, a gland under the male bladder that produces seminal fluid. Jevtana is used in cases where the carcinoma has spread to other parts of the body (metastatic) and no longer responds to hormonal 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 drug can only be obtained with a prescription.
How is Jevtana - cabazitaxel used?
Jevtana should only be used in units specializing in chemotherapy (cancer treatment drugs) under the supervision of a physician experienced in the use of chemotherapy.
Jevtana is given once every three weeks as an hour-long infusion, at a dose of 25 mg per square meter of body surface area (calculated based on patient weight and height). It is given in combination with prednisone or prednisolone, which are taken as 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 antiallergic medicines to reduce the risk of allergic reactions and anti-emetic medicines to prevent vomiting.
How does Jevtana - cabazitaxel work?
The active substance present 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. This skeleton remaining intact, the cells cannot divide and eventually die. Jevtana also acts on non-tumor cells, such as blood and nerve cells, causing side effects.
What studies have been carried out on Jevtana - cabazitaxel?
The effects of Jevtana were first tested in experimental models before being studied in humans.
Jevtana was analyzed 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 given in combination with the daily dose of prednisone or prednisolone. The main evaluation of efficacy 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 of Jevtana (seen in more than 1 patient in 10) are anemia (low number of red blood cells), leukopenia (low white blood cell count), neutropenia (low number of neutrophils, a type of white blood cell), thrombocytopenia (low number of platelets) and diarrhea. 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, other taxanes or any of the other ingredients. It must not be administered to patients with blood neutrophil counts below 1, 500 / mm3, who have abnormal liver test results indicating liver problems or who have recently received a yellow fever vaccine or 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 on Jevtana - cabazitaxel
On 17 March 2011, the European Commission issued a marketing authorization valid for Jevtana to Sanofi-Aventis, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
For more information on treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03/2011.
