Cabazitaxel Accord

Cabazitaxel Accord can only be obtained with a prescription and 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.

Cabazitaxel Accord is available as a concentrate to be made up into a solution for infusion (drip) into a vein. It is given once every three weeks as an infusion lasting one hour, at a dose based on the patient’s weight and height. It is given in combination with prednisone or prednisolone, taken daily throughout treatment.

The doctor may have to reduce the dose of Cabazitaxel Accord or stop treatment if the patient has certain side effects. The dose should also be reduced in patients with mildly reduced liver function.  Cabazitaxel Accord must not be given to patients with moderately or severely reduced liver function.

Before receiving Cabazitaxel Accord infusion, patients should first be given medicines to prevent allergic reactions and medicines to prevent vomiting.

For more information about using Cabazitaxel Accord, see the package leaflet or contact your doctor or pharmacist.

The active substance in Cabazitaxel Accord, cabazitaxel, belongs to the group of cancer medicines known as ‘taxanes’. Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton’, which allows them to divide and multiply. With their skeleton still in place, the cells cannot divide and eventually die. Cabazitaxel Accord also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Jevtana, and do not need to be repeated for Cabazitaxel Accord.

As for every medicine, the company provided studies on the quality of Cabazitaxel Accord. There was no need for bioequivalence studies to investigate whether Cabazitaxel Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Cabazitaxel Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

Because Cabazitaxel Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Cabazitaxel Accord has been shown to have comparable quality and to be bioequivalent to Jevtana. Therefore, the Agency’s view was that, as for Jevtana, the benefits of Cabazitaxel Accord outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cabazitaxel Accord have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Cabazitaxel Accord are continuously monitored. Side effects reported with Cabazitaxel Accord are carefully evaluated and any necessary action taken to protect patients.

Cabazitaxel Accord received a marketing authorisation valid throughout the EU on 28 August 2020.