Azacitidine betapharm

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

Azacitidine betapharm can only be obtained with a prescription and treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines. Before receiving Azacitidine betapharm, patients should receive medicines to prevent nausea (feeling sick) and vomiting.

The recommended dose of Azacitidine betapharm 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 1 week, followed by 3 weeks with no treatment. This 4-week period is one ‘cycle’. Treatment is given for at least 6 cycles and, if it is working, it is continued 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 betapharm, see the package leaflet or contact your doctor or pharmacist.

The active substance in Azacitidine betapharm, azacitidine, belongs to the group ‘antimetabolites’. 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 by interfering with the production of new RNA and DNA. These actions are expected to correct problems with the development of blood cells in the bone marrow that cause myelodysplastic disorders and to kill cancerous cells in leukaemia.

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

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

Azacitidine betapharm received a marketing authorisation valid throughout the EU on 24 March 2020.

Because Azacitidine betapharm 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.

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 betapharm.

As for every medicine, the company provided studies on the quality of Azacitidine betapharm. There was no need for ‘bioequivalence’ studies to investigate whether Azacitidine betapharm 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 betapharm is the same as that of 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.