This is a summary of the European public assessment report (EPAR) for Epoetin Alfa Hexal. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Epoetin Alfa Hexal.
- What is Epoetin Alfa Hexal?
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.
- What is Epoetin Alfa Hexal used for?
Epoetin Alfa Hexal is used for the following:
- to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘chronic kidney 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 and normal blood iron levels 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.
- How is Epoetin Alfa Hexal used?
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 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 the patient’s response.
For patients with kidney 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 summary of product characteristics (also part of the EPAR).
- How does Epoetin Alfa Hexal work?
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.
- How has Epoetin Alfa Hexal been studied?
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.
A further study looked at the effects of Epoetin Alfa Hexal given under the skin in 416 patients with chronic kidney failure.
- What benefit has Epoetin Alfa Hexal shown during the studies?
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 study in patients with chronic kidney failure showed that Epoetin Alfa Hexal was safe and effective when given under the skin.
- What is the risk associated with Epoetin Alfa Hexal?
The most common side effects with Epoetin Alfa Hexal (seen in more than 1 patient in 10) are nausea (feeling sick), diarrhoea, vomiting, pyrexia (fever) and headache. Flu-like illness may occur especially at the start of treatment. For the full list of all side effects reported with 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.
When Epoetin Alfa Hexal is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed. It must 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. For the full list of restrictions, see the package leaflet.
- Why has Epoetin Alfa Hexal been approved?
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.
A risk management plan has been developed to ensure that Epoetin Alfa Hexal is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epoetin Alfa Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
- Other information about Epoetin Alfa Hexal:
The European Commission granted a marketing authorisation valid throughout the European Union for Epoetin Alfa Hexal on 28 August 2007.
For more information about treatment with Epoetin Alfa Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 10/05/2016 .
31/03/2016 Epoetin Alfa Hexal -EMEA/H/C/000726 -WS/0877
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
- treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;
- Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.
Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Epoetin Alfa Hexal : EPAR - Procedural steps taken and scientific information after authorisation||HR = Hrvatski||12/10/2009||10/05/2016|
|Epoetin Alfa Hexal-H-C-726-X-10 : EPAR - Assessment Report - Variation||HR = Hrvatski||16/12/2008|
|CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal on 23 October 2008||HR = Hrvatski||23/10/2008|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Epoetin Alfa Hexal : EPAR - Procedural steps taken before authorisation||HR = Hrvatski||17/09/2007|
|Epoetin Alfa Hexal : EPAR - Scientific Discussion||HR = Hrvatski||13/09/2007|
This medicine is approved for use in the European Union