Jevtana: EPAR Summary For Public Use - Cancer Treatment For Prostate Cancer.pdf

Summary for the Public

What is Jevtana?

Jevtana is a cancer medicine used to treat men with advanced prostate cancer that has spread beyond the prostate (metastatic castration-resistant prostate cancer). It's used in combination with prednisone or prednisolone after previous treatment with another cancer drug, docetaxel.

How does it work?

Jevtana contains cabazitaxel, a substance that belongs to a group of drugs called taxanes. These drugs interfere with the ability of cancer cells to divide and multiply by targeting their internal "skeleton."

What are the benefits?

Clinical trials showed Jevtana extended overall survival (average length of life) in men with metastatic castration-resistant prostate cancer who had previously received docetaxel, compared to another cancer drug, mitoxantrone.

What are the side effects?

Common side effects include:

Anaemia
Leucopenia (low white blood cell count)
Neutropenia
Thrombocytopenia (low blood platelet count)
* Diarrhea

More serious side effects are possible. See the package leaflet for a full list. Jevtana should not be used by people with certain allergies, low blood counts, severe liver problems, or who have recently received a yellow fever vaccine.

Why was Jevtana approved?

The European Medicines Agency (EMA) found that Jevtana's benefits in prolonging overall survival outweigh its risks and recommended its approval.

How is Jevtana used?

Jevtana is administered by intravenous infusion every three weeks. It must be used under the supervision of a doctor experienced in chemotherapy.

Where can I get more information?

The full European Public Assessment Report (EPAR) for Jevtana is available on the EMA website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. Always consult your doctor or pharmacist for personalized advice.