Silapo

epoetin zeta

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

What is Silapo?

Silapo is a solution for injection. It is available in prefilled syringes containing between 1,000 and 40,000 international units (IU) of the active substance epoetin zeta.

Silapo is a ‘biosimilar medicine'. This means that Silapo is similar to a biological medicine (the ‘reference medicine’) that is already authorised in the European Union (EU), and contains a similar active substance to the reference medicine.

The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa.

What is Silapo used for?

Silapo 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 to treat certain types of cancer and to reduce the need for blood transfusions;
  • to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery.

The medicine can only be obtained with a prescription.

How is Silapo used?

Treatment with Silapo must be started under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.

For patients with kidney problems, Silapo can be injected into a vein or under the skin. For patients receiving chemotherapy, it must be injected under the skin, and for patients about to undergo surgery, it must be injected into a vein over at least one to five minutes. The dose, the frequency of injection and how long Silapo is used for depend on why it is being used and the patient’s bodyweight, 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. The lowest dose that provides adequate control of symptoms should be used.

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. Silapo can be injected under the skin by the patient or their carer if they have been trained appropriately. For full details, see the package leaflet.

How does Silapo 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 to help patients produce more blood for self-donation.

The active substance in Silapo, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production. It 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 zeta.

How has Silapo been studied?

Silapo was studied to show that it is comparable with the reference medicine, Eprex/Erypo, in experimental models and in humans.

Silapo, injected into a vein, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a technique for removing waste products from the blood). The first study compared the effects of Silapo with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks. The second study compared the effects of Silapo with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients. All of the patients in the second study had been receiving treatment with Eprex/Erypo for at least three months before they were either switched to Silapo or remained on Eprex/Erypo for 12 weeks. After that, the two groups switched to receiving the other medicine for a further 12 weeks. In both studies, the main measures of effectiveness were the levels of haemoglobin during treatment, as well as the dose of epoetin received.

The company also presented the results of two studies looking at the effects of Silapo injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.

What benefit has Silapo shown during the studies?

Silapo was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts. In the correction study, haemoglobin levels were around 11.6 g/dl during the last four weeks of the study, having risen from around 8.0 g/dl before treatment. In the study of patients already being treated with an epoetin, haemoglobin levels were maintained at around 11.4 g/dl when the patients were receiving Silapo and when they were receiving Eprex/Erypo. In both studies, the dose of epoetin received was similar with both medicines.

Silapo was also effective when it was injected under the skin. The study in patients receiving chemotherapy showed that Silapo brought about similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins. Silapo was also as effective as the reference medicine in patients with kidney problems.

What is the risk associated with Silapo?

As with other medicines containing an epoetin, side effects during treatment are mainly observed in patients with chronic renal failure and cancer. The most common side effects with Silapo are headache and an increase in blood pressure. A severe rise in blood pressure can sometimes be accompanied with symptoms of encephalopathy (brain problems) such as sudden stabbing migraine-like headache. For the full list of all side effects reported with Silapo, see the package leaflet.

Silapo must not be used in people who are hypersensitive (allergic) to epoetin zeta or any of the other ingredients. It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.

Why has Silapo been approved?

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

Other information about Silapo:

The European Commission granted a marketing authorisation valid throughout the EU for Silapo on 18 December 2007.

For more information about treatment with Silapo, read the package leaflet (also part of the EPAR).

Name Language First published Last updated
Silapo : EPAR - Summary for the public BG = bălgarski 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public ES = español 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public CS = čeština 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public DA = dansk 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public DE = Deutsch 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public ET = eesti keel 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public EL = elliniká 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public EN = English 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public FR = français 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public IT = italiano 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public LV = latviešu valoda 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public LT = lietuvių kalba 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public HU = magyar 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public MT = Malti 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public NL = Nederlands 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public PL = polski 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public PT = português 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public RO = română 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public SK = slovenčina 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public SL = slovenščina 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public FI = suomi 15/01/2008 21/08/2012
Silapo : EPAR - Summary for the public SV = svenska 15/01/2008 21/08/2012

This EPAR was last updated on 18/11/2015 .

Authorisation details

Product details

Product details for Silapo
NameSilapo
Agency product numberEMEA/H/C/000760
Active substance

epoetin zeta

International non-proprietary name (INN) or common name

epoetin zeta

Therapeutic area AnemiaKidney Failure, ChronicBlood Transfusion, AutologousCancer
Anatomical therapeutic chemical (ATC) code B03XA01
Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Silapo
Marketing-authorisation holder

Stada Arzneimittel AG

Revision11
Date of issue of marketing authorisation valid throughout the European Union18/12/2007

Contact address:

Stada R&D AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Product information

Product information

16/10/2015  Silapo -EMEA/H/C/000760 -IB/0039

Name Language First published Last updated
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015
Silapo : EPAR - Product Information SV = svenska 10/12/2008 18/11/2015

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.


Name Language First published Last updated
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  
Silapo : EPAR - All Authorised presentations SV = svenska 22/05/2009  

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 CRF in adult and paediatric 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).
  • Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Silapo : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 10/12/2008 18/11/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Silapo : EPAR - Procedural steps taken before authorisation SV = svenska 15/01/2008  
Silapo : EPAR - Scientific Discussion SV = svenska 15/01/2008  

Authorised

This medicine is approved for use in the European Union

More information on Silapo