Epoetin alfa HEXAL 20,000 IU/0.5 ml solution for injection in apre-filled syringe

Epoetin Alfa Hexal is a solution for injection. It is available in pre filled syringes that contain between 1,000 and 40,000 international units (IU) of the active substance, epoetin alfa.

Epoetin Alfa Hexal is a ?biosimilar? medicine. This means that Epoetin Alfa Hexal is similar to and contains the same active substance as a biological medicine that is already authorised in the European Union (EU), which is known as the ?reference medicine?. The reference medicine for Epoetin Alfa Hexal is Eprex/Erypo. For more information on biosimilar medicines, see the question-and-answer document here.

Epoetin Alfa Hexal is used in the following situations:

to treat anaemia low red blood cell counts that is causing symptoms in patients with chronic renal failure long-term, progressive decrease in the ability of the kidneys to work properly or other kidney problems

to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions

to increase the amount of blood that can be taken in adult patients with moderate anaemia who are going to have an operation and donate their own blood before surgery autologous blood transfusion

to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic bone surgery, such as hip surgery. It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.

The medicine can only be obtained with a prescription.

Treatment with Epoetin Alfa Hexal must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for. The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.

Epoetin Alfa Hexal is given as an injection into a vein in patients who are going to donate their own blood, and as an injection under the skin in patients receiving chemotherapy or about to undergo orthopaedic surgery. 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 depend on why Epoetin Alfa Hexal is being used, and are adjusted according to the patient?s response.

For patients with chronic renal failure 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 full details, see the package leaflet.

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 from 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 enough to the erythropoietin it has naturally. In these cases, epoetin alfa is used to replace the missing hormone or 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.

The epoetin alfa in Epoetin Alfa Hexal is produced by ?recombinant DNA technology?: it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin alfa.

Epoetin Alfa Hexal was studied to show that it is comparable to the reference medicine, Eprex/Erypo. 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 eight 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. The company also presented the results of a study comparing the effects of Epoetin Alfa Hexal injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.

Epoetin Alfa Hexal was as effective as Eprex/Erypo in increasing and maintaining red blood cell counts.

In the study of patients with anaemia caused by kidney problems, patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo. The study in patients receiving chemotherapy showed that Epoetin Alfa Hexal was also as effective as Eprex/Erypo when it was injected under the skin.

The most common side effect with Epoetin Alfa Hexal (seen in more than 1 patient in 10) is nausea (feeling sick). In cancer patients, headache and pyrexia (fever) are also seen in more than 1 patient in 10, and in patients with chronic renal failure, arthralgia (joint pain) and influenza (flu)-like illness are also seen in more than 1 patient in 10. For the full list of all side effects reported with Epoetin Alfa Hexal, see the package leaflet.

Epoetin Alfa Hexal should not be used in people who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients. It 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 who cannot receive medicines for the prevention of blood clots.

Epoetin Alfa Hexal must not be used in patients who are going to donate their own blood if they have had a heart attack or stroke within the last month, who have angina pectoris (pains to the chest, jaw and back due to problems with the blood flow to the heart) or who are at risk of deep venous thrombosis (DVT: formation of blood clots in the deep veins of the body, usually in the leg). It must also not be used in patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.

The CHMP concluded that, in accordance with EU requirements, Epoetin Alfa Hexal has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo. Therefore, the CHMP?s view was that, as for Eprex/Erypo, the benefit outweighs the identified risks. The Committee recommended that Epoetin Alfa Hexal be given marketing authorisation.