Binocrit

epoetin alfa

This is a summary of the European public assessment report (EPAR) for Binocrit. 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 Binocrit.

The medicine can only be obtained with a prescription.

This summary was last updated in 02-2011.

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 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.

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 in patients with kidney problems and 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 Binocrit 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.

How does Binocrit work?

A hormone called erythropoietin stimulates 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, erythropoietin is used to replace the missing hormone or to increase red blood cell counts. Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss. 

The active substance in Binocrit, epoetin alfa, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production. The epoetin alfa in Binocrit is produced by a method known as ‘recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin alfa.

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.

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.

What is the risk associated with Binocrit?

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

Binocrit 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.

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.

Which measures are being taken to ensure the safe use of Binocrit?

The company that makes Binocrit will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.

Other information about Binocrit

The European Commission granted a marketing authorisation valid throughout the European Union for Binocrit to Sandoz GmbH on 28 August 2007. The marketing authorisation is valid for five years, after which it can be renewed.

This EPAR was last updated on 18/04/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

28/03/2011  Binocrit -EMEA/H/C/000725 -N-0022

Contents

• 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.

Pharmacotherapeutic group

Antianemic preparations

Therapeutic indication

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 (See section 4.4).
• Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4).
• 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

Initial marketing-authorisation documents