Fexeric

ferric citrate coordination complex

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This is a summary of the European public assessment report (EPAR) for Fexeric. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fexeric.

For practical information about using Fexeric, patients should read the package leaflet or contact their doctor or pharmacist.

What is Fexeric and what is it used for?

Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease. It contains the active substance ferric citrate coordination complex.

How is Fexeric used?

Fexeric is available as 1 g tablets. The recommended starting dose is 3 to 6 tablets per day, taken in divided doses together with meals. The maximum dose is 12 tablets per day. Blood-phosphate levels should be monitored regularly during treatment. Patients should keep to their prescribed low-phosphate diets.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Fexeric work?

Patients with severe kidney disease have difficulty eliminating phosphate from their bodies. A build-up of phosphate leads to hyperphosphataemia and in the long-term can cause complications such as heart and bone disease.

The active substance in Fexeric, ferric citrate coordination complex, is a phosphate binder. When taken with meals, the iron contained in Fexeric binds to phosphate from food in the gut, forming a compound that is then eliminated in the stools. This prevents the phosphate from being absorbed into the body and helps to keep down the phosphate levels in the blood.

What benefits of Fexeric have been shown in studies?

Fexeric was shown to be effective at controlling blood-phosphate levels in 2 main studies in patients with long-term kidney disease and hyperphosphataemia. Both studies looked at the change in the amount of phosphate in the blood, measured in mg/dl.

In the first study, Fexeric was as effective as sevelamer carbonate, an approved medicine, in lowering phosphate levels in 359 patients with long-term kidney disease: after 12 weeks both treatments resulted in a reduction in phosphate levels of around 2 mg/dl.

In the second study, 149 patients who were not on dialysis received either Fexeric or placebo for 3 months. The study showed that blood-phosphate levels fell on average by 0.7 mg/dl with Fexeric compared with 0.3 mg/dl with placebo.

What are the risks associated with Fexeric?

The most common side effects with Fexeric (which may affect more than 1 in 10 people) are changes in bowel movements (diarrhoea or constipation) and discoloured faeces. Serious side effects were uncommon and mainly affected the gut and stomach. For the full list of all side effects reported with Fexeric, see the package leaflet.

Fexeric must not be used in patients with low blood-phosphate levels, patients who have severe problems with the stomach and gut (such as bleeding from the gut), and those with iron accumulation disorders such as haemochromatosis. For the full list of restrictions, see the package leaflet.

Why is Fexeric approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Fexeric’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Fexeric is effective at controlling blood-phosphate levels in patients with long-term kidney disease, whether they are on dialysis or not. The overall safety profile was considered acceptable and comparable to other phosphate binders.

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

A risk management plan has been developed to ensure that Fexeric is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fexeric, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Fexeric will carry out a study to gain further information on the long-term safety of Fexeric, particularly in older patients.

Further information can be found in the summary of the risk management plan.

Other information about Fexeric

The European Commission granted a marketing authorisation valid throughout the European Union for Fexeric on 23 September 2015.

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

Name Language First published Last updated
Fexeric : EPAR - Summary for the public BG = bălgarski 2015-10-02  
Fexeric : EPAR - Summary for the public ES = español 2015-10-02  
Fexeric : EPAR - Summary for the public CS = čeština 2015-10-02  
Fexeric : EPAR - Summary for the public DA = dansk 2015-10-02  
Fexeric : EPAR - Summary for the public DE = Deutsch 2015-10-02  
Fexeric : EPAR - Summary for the public ET = eesti keel 2015-10-02  
Fexeric : EPAR - Summary for the public EL = elliniká 2015-10-02  
Fexeric : EPAR - Summary for the public EN = English 2015-10-02  
Fexeric : EPAR - Summary for the public FR = français 2015-10-02  
Fexeric : EPAR - Summary for the public IT = italiano 2015-10-02  
Fexeric : EPAR - Summary for the public LV = latviešu valoda 2015-10-02  
Fexeric : EPAR - Summary for the public LT = lietuvių kalba 2015-10-02  
Fexeric : EPAR - Summary for the public HU = magyar 2015-10-02  
Fexeric : EPAR - Summary for the public MT = Malti 2015-10-02  
Fexeric : EPAR - Summary for the public NL = Nederlands 2015-10-02  
Fexeric : EPAR - Summary for the public PL = polski 2015-10-02  
Fexeric : EPAR - Summary for the public PT = português 2015-10-02  
Fexeric : EPAR - Summary for the public RO = română 2015-10-02  
Fexeric : EPAR - Summary for the public SK = slovenčina 2015-10-02  
Fexeric : EPAR - Summary for the public SL = slovenščina 2015-10-02  
Fexeric : EPAR - Summary for the public FI = suomi 2015-10-02  
Fexeric : EPAR - Summary for the public SV = svenska 2015-10-02  
Fexeric : EPAR - Summary for the public HR = Hrvatski 2015-10-02  
Name Language First published Last updated
Fexeric : EPAR - Risk-management-plan summary (English only) 2015-10-02  

This EPAR was last updated on 17/11/2016 .

Authorisation details

Product details

Product details for Fexeric
NameFexeric
Agency product numberEMEA/H/C/003776
Active substance

ferric citrate coordination complex

International non-proprietary name (INN) or common name

ferric citrate coordination complex

Therapeutic area HyperphosphatemiaRenal Dialysis
Anatomical therapeutic chemical (ATC) code V03AE
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Fexeric
Marketing-authorisation holder

Keryx Biopharma UK Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union23/09/2015

Contact address:

Keryx Biopharma UK Ltd
Riverbank House
2 Swan Lane 
London EC4R 3TT
United Kingdom

Product information

Product information

12/10/2016  Fexeric -EMEA/H/C/003776 -IB/0007

Name Language First published Last updated
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17
Fexeric : EPAR - Product Information EN = English 2015-10-02 2016-11-17

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
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  
Fexeric : EPAR - All Authorised presentations EN = English 2015-10-02  

Pharmacotherapeutic group

Drugs for treatment of hyperkalaemia and hyperphosphataemia

Therapeutic indication

Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Fexeric : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-11-17  

Initial marketing-authorisation documents

Name Language First published Last updated
Fexeric : EPAR - Public assessment report EN = English 2015-10-02  
CHMP summary of positive opinion for Fexeric EN = English 2015-07-24  

Authorised

This medicine is approved for use in the European Union