Epoetin Alfa Hexal

Epoetin Alfa Hexal can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Epoetin Alfa Hexal is used for. The iron levels of all patients should be checked to make sure that they are not too low, and iron supplements given if necessary.

Epoetin Alfa Hexal is available in pre-filled syringes of various strengths and is given as an injection into a vein or as an injection under the skin, depending on the  condition for which the patient is being treated. The injection under the skin may be given by the patient or their carer if they have been appropriately trained. The dose, the frequency of injection and how long it is used for also depend on why Epoetin Alfa Hexal is being used and on the patient’s bodyweight, and are adjusted according to how well the medicine is working.

For patients with kidney failure, myelodysplastic syndromes or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children). Haemoglobin is the protein in red blood cells that carries oxygen around the body. For these patients, the lowest dose that provides adequate control of symptoms should be used.

For more information about using Epoetin Alfa Hexal, see the package leaflet or contact your doctor or pharmacist.

The active substance in Epoetin Alfa Hexal, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow. Erythropoietin is produced by the kidneys. In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding well enough to natural erythropoietin. In these cases, epoetin alfa is used to increase red blood cell counts. Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.

Laboratory studies comparing Epoetin Alfa Hexal with the reference medicine Eprex/Erypo have shown that the active substance in Epoetin Alfa Hexal is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity. Studies have also shown that giving Epoetin Alfa Hexal produces similar levels of the active substance in the body to giving Eprex/Erypo.

In addition, Epoetin Alfa Hexal was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies.

 Epoetin Alfa Hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems. All of the patients had been receiving Eprex/Erypo injected into a vein for at least 8 weeks before they were either switched to Epoetin Alfa Hexal or remained on Eprex/Erypo. The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29. Patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo. A further study showed that Epoetin Alfa Hexal was safe and effective when given under the skin in 416 patients with chronic kidney failure.

Another study showed that Epoetin Alfa Hexal injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.

Because Epoetin Alfa Hexal is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Epoetin Alfa Hexal.

The most common side effects with Epoetin Alfa Hexal (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, vomiting, fever and headache. Flu-like illness may occur especially at the start of treatment. For the full list of side effects of Epoetin Alfa Hexal, see the package leaflet.

Epoetin Alfa Hexal must not be used in the following groups:

• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin;
• patients with high blood pressure that is not controlled;
• patients undergoing surgery who cannot receive medicines for the prevention of blood clots;
• patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.

When Epoetin Alfa Hexal is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.

For the full list of restrictions, see the package leaflet.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Epoetin Alfa Hexal has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way. In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy. Therefore the Agency’s view was that, as for Eprex/Erypo, the benefit of Epoetin Alfa Hexal outweighs the identified risk and it can be authorised.

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

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

Epoetin Alfa Hexal received a marketing authorisation valid throughout the EU on 28 August 2007.