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Active Substance: epoetin alfa
Common Name: epoetin alfa
ATC Code: B03XA01
Marketing Authorisation Holder: Sandoz GmbH
Active Substance: epoetin alfa
Status: Authorised
Authorisation Date: 2007-08-28
Therapeutic Area: Anemia Kidney Failure, Chronic
Pharmacotherapeutic Group: Antianemic preparations

Therapeutic indication

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:

What is Binocrit?

Binocrit 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.

Binocrit is a ‘biosimilar’ medicine. This means that Binocrit 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 Binocrit is Eprex/Erypo.

What is Binocrit used for?

Binocrit is used for the following:

The medicine can only be obtained with a prescription.

How is Binocrit used?

Treatment with Binocrit 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.

Binocrit 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 Binocrit 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 Binocrit work?

The active substance in Binocrit, 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 Binocrit been studied?

Binocrit was studied to show that it is comparable to the reference medicine, Eprex/Erypo. Binocrit, 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 Binocrit 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 Binocrit 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 Binocrit given under the skin in 416 patients with chronic kidney failure.

What benefit has Binocrit shown during the studies?

Binocrit 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 Binocrit maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo. The study in patients receiving chemotherapy showed that Binocrit was also as effective as Eprex/Erypo when it was injected under the skin.

The study in patients with chronic kidney failure showed that Binocrit was safe and effective when given under the skin.

What is the risk associated with Binocrit?

The most common side effects with Binocrit (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 Binocrit, see the package leaflet.

Binocrit must not be used in the following groups:

When Binocrit 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 Binocrit been approved?

The CHMP concluded that, in accordance with EU requirements, Binocrit 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 Binocrit be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Binocrit?

A risk management plan has been developed to ensure that Binocrit 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 Binocrit, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Binocrit

The European Commission granted a marketing authorisation valid throughout the European Union for Binocrit on 28 August 2007.

For more information about treatment with Binocrit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.