Azacitidine Accord

The medicine can only be obtained with a prescription.

Azacitidine Accord treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines. Patients should receive medicines to prevent nausea (feeling sick) and vomiting before receiving Azacitidine Accord.

The recommended dose of Azacitidine Accord depends on the patient’s height and weight. It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment. This four-week period is one ‘cycle’. Treatment continues for at least six cycles and then for as long as it benefits the patient. The liver, kidneys and blood should be checked before each cycle. If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.

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

The active substance in Azacitidine Accord, azacitidine, belongs to the group ‘anti‑metabolites’. Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA). It is thought to work by changing the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA. These actions are expected to correct problems with the maturation and growth of blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.

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

As for every medicine, the company provided studies on the quality of Azacitidine Accord. There was no need for ‘bioequivalence’ studies to investigate whether Azacitidine Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Azacitidine Accord is the same as the reference medicine and when given by injection under the skin, the active substance in both products is expected to be absorbed in the same way.

Because Azacitidine 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, Azacitidine Accord has been shown to be comparable to Vidaza. Therefore, the Agency’s view was that, as for Vidaza, the benefits of Azacitidine 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 Azacitidine Accord have been included in the summary of product characteristics and the package leaflet.

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

Azacitidine Accord received a marketing authorisation valid throughout the EU on 13 February 2020.