Eporatio

epoetin theta

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Eporatio?

Eporatio is a solution for injection. It is available in prefilled syringes containing between 1,000 and 30,000 international units (IU) of the active substance, epoetin theta.

What is Eporatio used for?

Eporatio is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms. It is used in adults with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) and in adults with non-myeloid cancer (cancer not originating in the bone marrow) who are receiving chemotherapy (medicines to treat cancer).

The medicine can only be obtained with a prescription.

How is Eporatio used?

Eporatio treatment should be started by a doctor experienced in treating symptomatic anaemia in patients with chronic renal failure and non-myeloid cancer.

For patients with kidney failure, in the ‘correction phase’, the initial recommended dose, given three times a week, is 20 IU per kilogram body weight for injections under the skin or 40 IU per kg body weight for injections into a vein. These doses may be doubled after four weeks if the improvement is not enough and may be increased further at monthly intervals by a quarter of the previous dose until the right level of haemoglobin (the protein found in red blood cells that carries oxygen around the body) is achieved. When the anaemia has been corrected, the dose in the ‘maintenance phase’ should be adjusted to maintain the right level of haemoglobin. The weekly dose of Eporatio should not at any time be more than 700 IU per kg body weight.

For patients with cancer, injections should be given under the skin. The initial recommended dose is 20,000 IU once a week for all patients irrespective of their body weight. This dose may be doubled after four weeks if the haemoglobin has not increased by at least 1 g/dl and can, if needed, be increased further to 60,000 IU after four additional weeks. The weekly dose of Eporatio should not be more than 60,000 IU. Patients with cancer should continue to receive treatment for up to four weeks after they stop receiving chemotherapy.

Patients who receive Eporatio by injection under the skin may inject themselves once they have been trained appropriately. For full details, see the package leaflet.

How does Eporatio work?

The active substance in Eporatio, epoetin theta, is a copy of a human hormone called erythropoietin that 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. The epoetin theta in Eporatio works in the body in 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 theta.

How has Eporatio been studied?

The effects of Eporatio were first tested in experimental models before being studied in humans. There were four main studies in 842 chronic-renal-failure patients and three main studies in 586 non-myeloid-cancer patients receiving chemotherapy.

In the four renal-failure studies, patients were given either Eporatio (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia). The main measure of effectiveness in two of these studies was based on whether increasing the dose of Eporatio from 20 or 40 IU per kilogram body weight to 120 IU per kilogram body weight led to improvements in haemoglobin levels during the correction phase. The other two studies compared Eporatio with epoetin beta during the maintenance phase. The main measure of effectiveness was the average change in haemoglobin levels from 15 to 26 weeks after treatment.

In the cancer studies, the main measure of effectiveness was the number of patients receiving either Eporatio or placebo (a dummy treatment) with an increase in haemoglobin of 2 g/dl over 12 or 16 weeks.

What benefit has Eporatio shown during the studies?

Eporatio was effective at treating anaemia in patients with chronic renal failure and patients with non-myeloid cancer who were receiving chemotherapy.

In chronic-renal-failure patients, the correction phase showed that increasing the starting dose of Eporatio leads to improvements in haemoglobin levels. Average weekly increases in haemoglobin were 0.73 and 0.58 g/dl in patients receiving the higher dose of Eporatio compared with 0.20 and 0.26 g/dl in patients receiving the lower dose of Eporatio. The other two renal-failure studies showed that during the maintenance stage the change in haemoglobin levels was similar in patients receiving Eporatio and patients receiving epoetin beta.

In the cancer studies, between 64 and 73% of patients who received Eporatio had an increase in haemoglobin of 2 g/dl compared with between 20 and 26% of patients who were given placebo.

What is the risk associated with Eporatio?

The most common side effects with Eporatio (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness. For the full list of all side effects reported with Eporatio, see the package leaflet.

Eporatio should not be used in people who may be hypersensitive (allergic) to epoetin theta, to any other epoetins or substances derived from them, or to any of the other ingredients of Eporatio. It must not be used in patients with uncontrolled hypertension.

Because of the risk of high blood pressure, special care should be taken to monitor and control the patient’s blood pressure to avoid complications such as a hypertensive crisis.

Why has Eporatio been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Eporatio’s benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy. The Committee recommended that Eporatio be given marketing authorisation.

Other information about Eporatio:

The European Commission granted a marketing authorisation valid throughout the European Union for Eporatio to ratiopharm GmbH on 29 October 2009.

Name Language First published Last updated
Eporatio : EPAR - Summary for the public BG = bălgarski 16/12/2009  
Eporatio : EPAR - Summary for the public ES = español 16/12/2009  
Eporatio : EPAR - Summary for the public CS = čeština 16/12/2009  
Eporatio : EPAR - Summary for the public DA = dansk 16/12/2009  
Eporatio : EPAR - Summary for the public DE = Deutsch 16/12/2009  
Eporatio : EPAR - Summary for the public ET = eesti keel 16/12/2009  
Eporatio : EPAR - Summary for the public EL = elliniká 16/12/2009  
Eporatio : EPAR - Summary for the public EN = English 16/12/2009  
Eporatio : EPAR - Summary for the public FR = français 16/12/2009  
Eporatio : EPAR - Summary for the public IT = italiano 16/12/2009  
Eporatio : EPAR - Summary for the public LV = latviešu valoda 16/12/2009  
Eporatio : EPAR - Summary for the public LT = lietuvių kalba 16/12/2009  
Eporatio : EPAR - Summary for the public HU = magyar 16/12/2009  
Eporatio : EPAR - Summary for the public MT = Malti 16/12/2009  
Eporatio : EPAR - Summary for the public NL = Nederlands 16/12/2009  
Eporatio : EPAR - Summary for the public PL = polski 16/12/2009  
Eporatio : EPAR - Summary for the public PT = português 16/12/2009  
Eporatio : EPAR - Summary for the public RO = română 16/12/2009  
Eporatio : EPAR - Summary for the public SK = slovenčina 16/12/2009  
Eporatio : EPAR - Summary for the public SL = slovenščina 16/12/2009  
Eporatio : EPAR - Summary for the public FI = suomi 16/12/2009  
Eporatio : EPAR - Summary for the public SV = svenska 16/12/2009  

This EPAR was last updated on 30/03/2016 .

Authorisation details

Product details

Product details for Eporatio
NameEporatio
Agency product numberEMEA/H/C/001033
Active substance

epoetin theta

International non-proprietary name (INN) or common name

epoetin theta

Therapeutic area AnemiaKidney Failure, ChronicCancer
Anatomical therapeutic chemical (ATC) code B03XA01

Publication details

Publication details for Eporatio
Marketing-authorisation holder

ratiopharm GmbH

Revision8
Date of issue of marketing authorisation valid throughout the European Union29/10/2009

Contact address:

ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm
Germany

Product information

Product information

22/02/2016  Eporatio -EMEA/H/C/001033 -PSUSA/1240/201504

Name Language First published Last updated
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016
Eporatio : EPAR - Product Information SV = svenska 16/12/2009 30/03/2016

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
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015
Eporatio : EPAR - All Authorised presentations SV = svenska 16/12/2009 23/06/2015

Pharmacotherapeutic group

Anti-anaemic preparations

Therapeutic indication

Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.

Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Eporatio : EPAR - Public assessment report SV = svenska 16/12/2009  
Committee for medicinal products for human use summary of positive opinion for Eporatio SV = svenska 23/07/2009  

Authorised

This medicine is approved for use in the European Union