Silapo

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epoetin zeta

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 21/03/2019

Authorisation details

Product details
Name
Silapo
Agency product number
EMEA/H/C/000760
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
BiosimilarBiosimilar

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.

Publication details
Marketing-authorisation holder
Stada Arzneimittel AG
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
18/12/2007
Contact address

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

Product information

18/01/2019 Silapo - EMEA/H/C/000760 - IB/0052/G

Contents

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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).

Assessment history

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