Aranesp

darbepoetin alfa

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

What is Aranesp?

Aranesp is a solution for injection in a vial, a prefilled syringe or a prefilled pen. It contains the active substance darbepoetin alfa. Aranesp exists in various strengths, from 25 to 500 micrograms per millilitre.

What is Aranesp used for?

Aranesp is used to treat anaemia (low red-blood-cell counts) that is causing symptoms. It is used in two groups of patients:

  • adults and children with ‘chronic renal failure’ (long-term, progressive decrease in the ability of the kidneys to work properly);
  • adults who are receiving chemotherapy for ‘non-myeloid’ cancer (cancer not originating in the bone marrow).

The medicine can only be obtained with a prescription.

How is Aranesp used?

Aranesp treatment should be initiated by a doctor who has experience in treating the types of anaemia mentioned above.

For patients with chronic renal failure, Aranesp can be injected into a vein or under the skin. It must be injected under the skin in patients receiving chemotherapy. The dose and frequency of injection depend on why Aranesp is being used, and are to be adjusted, according to the patient’s response, to obtain haemoglobin levels that remain within the recommended range (between 10 and 12 grams per decilitre). 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.

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

How does Aranesp work?

A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow. Erythropoietin is produced by the kidneys. In patients with chronic renal failure, anaemia can be caused by a lack of erythropoietin. In patients receiving chemotherapy, anaemia can be caused by the body not responding sufficiently to the erythropoietin it has naturally.

Darbepoetin alfa, the active substance in Aranesp, acts exactly like the natural erythropoietin made by the body to stimulate red blood cell production, but it is very slightly different in its structure. This means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin. The darbepoetin alfa in Aranesp is produced by a method known as ‘recombinant DNA technology’: it is made by cells into which a gene (DNA) has been introduced, which make the cells able to produce darbepoetin alfa.

How has Aranesp been studied?

Aranesp has been studied in patients with chronic renal failure in four studies involving over 1,200 patients, in which it was compared with recombinant human erythropoietin. The main measure of effectiveness was the increase in haemoglobin. Aranesp has also been studied in 124 children with chronic renal failure to check that it is absorbed in the same way as in adults.

Aranesp has also been compared with placebo (a dummy treatment) in two studies involving 669 patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma. The main measure of effectiveness was the reduction in number of patients who needed a blood transfusion.

What benefit has Aranesp shown during the studies?

Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels in patients with chronic renal failure, and at keeping these levels maintained after they had been improved, whether given as an injection into a vein or under the skin.

In cancer patients receiving chemotherapy, fewer of the patients treated with Aranesp needed a blood transfusion than those given placebo.

What is the risk associated with Aranesp?

In kidney failure patients, the most common side effects with Aranesp (seen in more than 1 patient in 10) are hypersensitivity (allergy) and hypertension (high blood pressure) while in cancer patients the most common are hypersensitivity and oedema (fluid retention). For the full list of all side effects reported with Aranesp, see the package leaflet.

Aranesp must not be used in people who are hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients. It must not be used in patients who have poorly controlled high blood pressure.

Why has Aranesp been approved?

The CHMP decided that Aranesp’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Aranesp

The European Commission granted a marketing authorisation valid throughout the European Union for Aranesp on 8 June 2001.

For more information about treatment with Aranesp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Aranesp : EPAR - Summary for the public BG = bălgarski 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public ES = español 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public CS = čeština 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public DA = dansk 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public DE = Deutsch 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public ET = eesti keel 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public EL = elliniká 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public EN = English 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public FR = français 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public IT = italiano 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public LV = latviešu valoda 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public LT = lietuvių kalba 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public HU = magyar 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public MT = Malti 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public NL = Nederlands 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public PL = polski 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public PT = português 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public RO = română 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public SK = slovenčina 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public SL = slovenščina 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public FI = suomi 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public SV = svenska 2007-11-07 2013-11-06
Aranesp : EPAR - Summary for the public HR = Hrvatski 2007-11-07 2013-11-06

This EPAR was last updated on 06/04/2017 .

Authorisation details

Product details

Product details for Aranesp
NameAranesp
Agency product numberEMEA/H/C/000332
Active substance

darbepoetin alfa

International non-proprietary name (INN) or common name

darbepoetin alfa

Therapeutic area AnemiaKidney Failure, ChronicCancer
Anatomical therapeutic chemical (ATC) code B03XA02

Publication details

Publication details for Aranesp
Marketing-authorisation holder

Amgen Europe B.V.

Revision36
Date of issue of marketing authorisation valid throughout the European Union08/06/2001

Contact address:

Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

Product information

10/03/2017  Aranesp -EMEA/H/C/000332 -IAIN/0140

Name Language First published Last updated
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06
Aranesp : EPAR - Product Information HR = Hrvatski 2009-12-15 2017-04-06

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
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29
Aranesp : EPAR - All Authorised presentations HR = Hrvatski 2009-05-12 2011-03-29

Pharmacotherapeutic group

Anti-anaemic preparations

Therapeutic indication

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric 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
Aranesp : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-06-14  
Aranesp : EPAR - Scientific Discussion HR = Hrvatski 2006-06-14  

Authorised

This medicine is approved for use in the European Union