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 tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).

What is Ferriprox used for?

Ferriprox is an ‘iron chelator’ (a substance that attaches to iron) that 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:

  • on its own, when standard iron chelator treatment cannot be used or is inadequate;
  • in combination with another iron chelator, when treatment with one iron chelator on its own is ineffective or when prevention or treatment of life-threatening conditions (mainly affecting the heart) requires rapid or intensive correction of iron levels.

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. 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.

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 initially 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 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.

In addition, studies from the published literature in patients with thalassaemia major were provided to support use of Ferriprox in combination with another iron chelator.

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 or not such a schedule is as effective as deferoxamine taken on its own.

Published studies on use of Ferriprox together with deferoxamine reported greater reductions in blood ferritin levels when both medicines were used in combination compared with using either medicine on its own. In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.

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 eliminated), nausea (feeling sick), abdominal pain (stomach ache) and vomiting. Less common but more serious side effects are agranulocytosis (very low levels of granulocytes, a type of white blood cell) and neutropenia (low levels of neutrophils, a type of white blood cell). For the full list of all side effects reported with Ferriprox, see the package leaflet.

Ferriprox must not be used in people who have previously had neutropenia repeatedly or agranulocytosis. Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis. When taking Ferriprox, the patient’s neutrophil count should be checked every week. If the patient gets an infection, treatment with Ferriprox should be temporarily stopped and the neutrophil count checked more often. Patients should tell their doctor immediately if they have symptoms that might be due to an infection, such as fever, sore throat and flu-like symptoms.

Ferriprox must not be used in women who are pregnant or breastfeeding. For the full list of restrictions with Ferriprox, see the package leaflet.

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.

What measures are being taken to ensure the safe and effective use of Ferriprox?

Patients taking Ferriprox, or their carers, must be given a reminder card with information on how to take the medicine safely.

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

Other information about Ferriprox

The European Commission granted a marketing authorisation valid throughout the European Union for Ferriprox on 25 August 1999.

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 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public ES = español 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public CS = čeština 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public DA = dansk 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public DE = Deutsch 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public ET = eesti keel 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public EL = elliniká 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public EN = English 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public FR = français 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public IT = italiano 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public LV = latviešu valoda 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public LT = lietuvių kalba 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public HU = magyar 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public MT = Malti 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public NL = Nederlands 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public PL = polski 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public PT = português 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public RO = română 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public SK = slovenčina 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public SL = slovenščina 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public FI = suomi 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public SV = svenska 2009-10-27 2016-07-14
Ferriprox : EPAR - Summary for the public HR = Hrvatski 2009-10-27 2016-07-14

This EPAR was last updated on 14/07/2016 .

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

Revision20
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

26/05/2016  Ferriprox -EMEA/H/C/000236 -II/0103

Name Language First published Last updated
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14
Ferriprox : EPAR - Product Information HR = Hrvatski 2009-10-27 2016-07-14

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 HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06
Ferriprox : EPAR - All Authorised presentations HR = Hrvatski 2007-11-26 2010-09-06

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

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

Ferriprox in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2).

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 HR = Hrvatski 2006-07-10  
Ferriprox : EPAR - Scientific Discussion HR = Hrvatski 2006-07-10