Silapo

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Authorised

This medicine is authorised for use in the European Union

epoetin zeta
MedicineHumanAuthorised
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

Silapo is a medicine used for the following:

  • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, decreasing 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;

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

  • to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective). Silapo is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.

Silapo contains the active substance epoetin zeta and is a ‘biosimilar’ medicine. This means that Silapo is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa.

Silapo can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Silapo is approved for. The iron levels of all patients should be checked and iron supplements given if necessary.

Silapo is available in pre-filled syringes and is injected either into a vein or 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 a carer if they have been trained. The dose, how often it is given and how long it is used for also depend on why Silapo is being used and on the patient’s bodyweight, and are adjusted according to how well the medicine is working.

For patients with kidney failure, myelodysplastic syndromes or who are receiving chemotherapy, haemoglobin levels should remain within the recommended range. Haemoglobin is the protein in red blood cells that carries oxygen around the body. For these patients, the lowest dose that controls the symptoms well enough should be used.

For more information about using Silapo, see the package leaflet or contact your doctor or pharmacist.

The active substance in Silapo, epoetin zeta, is a copy of a hormone called erythropoietin, and works in the same way as the natural hormone to stimulate the production of red blood cells in 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 well enough to natural erythropoietin. In these cases, epoetin zeta is used to increase red blood cell counts. Epoetin zeta is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.

Laboratory studies comparing Silapo with Eprex/Erypo have shown that the active substance in Silapo is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity. Studies have also shown that giving Silapo produces similar levels of the active substance in the body to giving Eprex/Erypo.

Silapo, injected into a vein, was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a procedure 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. During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment. 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 received treatment with Eprex/Erypo for at least 3 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. Haemoglobin levels were maintained at around 11.4 g/dl in both groups.

The company also presented the results of two studies showing that Silapo injected under the skin is as effective as other epoetin medicines: one study involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.

Because Silapo is a biosimilar medicine, the studies on effectiveness and safety of epoetin carried out with Eprex/Erypo do not all need to be repeated for Silapo.

The most common side effects with Silapo (which may affect more than 1 in 100 people) are headache and increased blood pressure. For the full list of side effects of Silapo, see the package leaflet.

Silapo must not be used in the following groups:

  • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) after treatment with any epoetin medicine;

  • patients with hypertension (high blood pressure) that is not controlled;

  • patients who cannot receive medicines to prevent blood clots;

  • patients about to have surgery, including major orthopaedic surgery, and who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Silapo has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way. In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy. All these data were considered sufficient to conclude that Silapo will behave in the same way as Eprex/Erypo in terms of effectiveness and safety in its authorised uses. Therefore the Agency’s view was that, as for Eprex/Erypo, the benefit of Silapo outweighs the identified risk and it can be authorised.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silapo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Silapo are continuously monitored. Side effects reported with Silapo are carefully evaluated and any necessary action taken to protect patients.

Silapo received a marketing authorisation valid throughout the EU on 18 December 2007.

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Product information

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Latest procedure affecting product information: IB/0061
05/11/2020
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Product details

Name of medicine
Silapo
Active substance
epoetin zeta
International non-proprietary name (INN) or common name
epoetin zeta
Therapeutic area (MeSH)
  • Anemia
  • Blood Transfusion, Autologous
  • Cancer
  • Kidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code
B03XA01

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 adult and paediatric 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).

  • 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).

  • Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml).

  • Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ?10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).

Authorisation details

EMA product number
EMEA/H/C/000760

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation holder
Stada Arzneimittel AG

Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Opinion adopted
18/10/2007
Marketing authorisation issued
18/12/2007
Revision
17

Assessment history

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