Ferriprox

deferiprone

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

What is Ferriprox?

Ferriprox is a medicine that contains the active substance deferiprone. It is available as white, capsule-shaped tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).

What is Ferriprox used for?

Ferriprox is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major. This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body. Ferriprox is used when deferoxamine (the standard treatment for iron overload) cannot be used or is inadequate.

The medicine can only be obtained with a prescription.

How is Ferriprox used?

Ferriprox treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.

The usual dose of Ferriprox is 75 mg per kilogram body weight each day, divided into three separate doses. If the tablets are used, each dose is adjusted to the nearest half tablet. If the oral solution is used, the dose is adjusted to the nearest 2.5 ml. Doses above 100 mg/kg a day are not recommended because of a potentially increased risk of side effects. The doctor may adjust the dose of Ferriprox depending on the patient’s response, which should be measured every two to three months with blood tests. The doctor may interrupt treatment if iron levels in the body get too low.

Patients taking Ferriprox, or their carers, must be given a reminder card that reminds the patient how to take the medicine safely.

For more information, see the summary of product characteristics (also part of the EPAR).

How does Ferriprox work?

Patients with thalassaemia major need frequent blood transfusions. When patients receive repeated transfusions, the transfused red cells bring iron into the body. However, the body does not have a natural way of removing excess iron, so it builds up. Over time, the excess iron can damage important organs such as the heart or liver. The active substance in Ferriprox, deferiprone, is an ‘iron chelator’. It attaches to iron in the body to form a compound that can be excreted by the body, mainly in the urine, and to a lesser extent in the stools. This helps to correct the iron overload and prevent damage due to excess iron.

How has Ferriprox been studied?

Ferriprox was originally studied in three studies involving 247 patients over six years of age with thalassaemia major, with the main study comparing Ferriprox with deferoxamine in 71 patients over two years. The study was ‘open label’, meaning that the doctor and patients knew which medicine they were using, because Ferriprox was given by mouth, whereas deferoxamine was given by subcutaneous infusion (a very slow injection under the skin) overnight. A later study compared treatment alternating Ferriprox and deferoxamine (five days’ Ferriprox plus two days’ deferoxamine each week) with continuous treatment with deferoxamine on its own, in 60 patients over 12 months.

In all of the studies, the main measure of effectiveness was the change in the levels of ferritin in the blood. Ferritin is a protein that stores iron in the body. The blood ferritin level indicates how much iron is being stored in the body.

What benefit has Ferriprox shown during the studies?

In the initial study comparing Ferriprox with deferoxamine, the average blood ferritin levels were similar in the two treatment groups. However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.

In the alternating treatment study, the treatment schedule combining Ferriprox for five days with deferoxamine for two days reduced blood ferritin levels to the same extent as deferoxamine taken on its own. However, there were too few patients in the study to prove whether such a schedule is as effective as deferoxamine taken on its own or not.

What is the risk associated with Ferriprox?

The most common side effects with Ferriprox (seen in more than 1 patient in 10) are reddish-brown urine (showing that iron is being excreted), nausea (feeling sick), abdominal pain (stomach ache) and vomiting. A less common but serious side effect is agranulocytosis (very low levels of granulocytes, a type of white blood cell). For the full list of all side effects reported with Ferriprox, see the package leaflet.

Ferriprox should not be used in people who may be hypersensitive (allergic) to deferiprone or any of the other ingredients. Ferriprox must not be used in people who have had neutropenia (low levels of neutrophils, a type of white blood cell) repeatedly or agranulocytosis. Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis. Ferriprox must not be used in women who are pregnant or breast-feeding.

Why has Ferriprox been approved?

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

Other information about Ferriprox

The European Commission granted a marketing authorisation valid throughout the European Union for Ferriprox on 25 August 1999. The marketing authorisation holder is Apotex Europe B.V. The marketing authorisation is valid for an unlimited period.

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

Name Language First published Last updated
Ferriprox : EPAR - Summary for the public BG = bălgarski 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public ES = español 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public CS = čeština 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public DA = dansk 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public DE = Deutsch 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public ET = eesti keel 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public EL = elliniká 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public EN = English 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public FR = français 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public IT = italiano 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public LV = latviešu valoda 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public LT = lietuvių kalba 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public HU = magyar 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public MT = Malti 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public NL = Nederlands 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public PL = polski 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public PT = português 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public RO = română 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public SK = slovenčina 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public SL = slovenščina 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public FI = suomi 27/10/2009 06/09/2010
Ferriprox : EPAR - Summary for the public SV = svenska 27/10/2009 06/09/2010

This EPAR was last updated on 14/12/2015 .

Authorisation details

Product details

Product details for Ferriprox
NameFerriprox
Agency product numberEMEA/H/C/000236
Active substance

deferiprone

International non-proprietary name (INN) or common name

deferiprone

Therapeutic area beta-ThalassemiaIron Overload
Anatomical therapeutic chemical (ATC) code V03AC02

Publication details

Publication details for Ferriprox
Marketing-authorisation holder

Apotex Europe BV

Revision19
Date of issue of marketing authorisation valid throughout the European Union25/08/1999

Contact address:

Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
Netherlands

Product information

Product information

22/10/2015  Ferriprox -EMEA/H/C/000236 -II/0089/G

Name Language First published Last updated
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015
Ferriprox : EPAR - Product Information SV = svenska 27/10/2009 14/12/2015

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
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010
Ferriprox : EPAR - All Authorised presentations SV = svenska 26/11/2007 06/09/2010

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Ferriprox : EPAR - Procedural steps taken before authorisation SV = svenska 10/07/2006  
Ferriprox : EPAR - Scientific Discussion SV = svenska 10/07/2006