Velphoro

mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

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

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

What is Velphoro and what is it used for?

Velphoro is a medicine used to control blood-phosphate levels in adults with long-term kidney disease who are undergoing haemodialysis or peritoneal dialysis to remove waste products from the blood.

Velphoro is used with other treatments such as calcium or vitamin-D supplements which help to control bone disease linked to kidney failure and high phosphate levels.

The active substance in this medicine is sucroferric oxyhydroxide (also known as mixture of polynuclear iron(III)-oxyhydroxide, sucrose (sugar) and starches).

How is Velphoro used?

Velphoro is available as chewable tablets (containing 500 mg of iron). The recommended starting dose is 1,500 mg (3 tablets) a day, taken in divided doses together with meals. The dose of Velphoro should be adjusted every two to four weeks, until an acceptable level of phosphate in the blood is reached, which should then be monitored regularly. The maximum dose is 3,000 mg (6 tablets) per day. Patients should keep to their prescribed low-phosphate diets. The tablets must be chewed and not swallowed whole.

The medicine can only be obtained with a prescription.

How does Velphoro work?

Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia (high blood phosphate levels), which, in the long term, can cause complications such as heart and bone disease.

The active substance in Velphoro, sucroferric oxyhydroxide, is a phosphate binder. When taken with meals, the iron contained in Velphoro attaches to phosphate from food within the gut, preventing it from being absorbed into the body and helping to keep down the phosphate levels in the blood.

What benefits of Velphoro have been shown in studies?

Velphoro has been studied in one main study involving 1,059 adults with long-term kidney disease and hyperphosphataemia. All patients were on dialysis and received either Velphoro or another phosphate binder, sevelamer, for 6 months. After 6 months, more than half of the patients could then continue on the same treatment for up to one year, while a small group received Velphoro at a lower dose for three weeks only. The study looked at the change in the amount of phosphate in the blood, measured in units of mmol/L.

Velphoro was as effective as sevelamer in reducing patients’ blood-phosphate levels and maintaining this effect. After 3 months of treatment, blood-phosphate levels fell on average by 0.7 mmol/L with Velphoro compared with 0.8 mmol/L with sevelamer, and after 6 months of treatment 53% of patients on Velphoro had normal blood-phosphate levels (1.13 to 1.78 mmol/L) compared with 54% of patients on sevelamer. In patients whose dose of Velphoro was then lowered, phosphate levels increased after 3 weeks, whereas the levels remained stable in those who continued treatment on the same dose for up to one year.

What are the risks associated with Velphoro?

The most common side effects with Velphoro (which may affect more than 1 in 10 people) are diarrhoea and discoloured faeces, which may become less frequent with continued treatment.

Velphoro must not be used in patients with iron accumulation disorders such as haemochromatosis.

For the full list of all side effects and restrictions with Velphoro, see the package leaflet.

Why is Velphoro approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Velphoro’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Velphoro showed a clear beneficial effect in lowering phosphate levels. There were no major safety concerns and although tolerability is slightly lower than with sevelamer, the overall safety profile was acceptable. The risk of excess iron build-up was considered limited but should be followed up after approval.

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

A risk management plan has been developed to ensure that Velphoro 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 Velphoro, including the appropriate precautions to be followed by healthcare professionals and patients.

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

Other information about Velphoro

The European Commission granted a marketing authorisation valid throughout the European Union for Velphoro on 26 August 2014.

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

Name Language First published Last updated
Velphoro : EPAR - Summary for the public BG = bălgarski 2014-10-13  
Velphoro : EPAR - Summary for the public ES = español 2014-10-13  
Velphoro : EPAR - Summary for the public CS = čeština 2014-10-13  
Velphoro : EPAR - Summary for the public DA = dansk 2014-10-13  
Velphoro : EPAR - Summary for the public DE = Deutsch 2014-10-13  
Velphoro : EPAR - Summary for the public ET = eesti keel 2014-10-13  
Velphoro : EPAR - Summary for the public EL = elliniká 2014-10-13  
Velphoro : EPAR - Summary for the public EN = English 2014-10-13  
Velphoro : EPAR - Summary for the public FR = français 2014-10-13  
Velphoro : EPAR - Summary for the public IT = italiano 2014-10-13  
Velphoro : EPAR - Summary for the public LV = latviešu valoda 2014-10-13  
Velphoro : EPAR - Summary for the public LT = lietuvių kalba 2014-10-13  
Velphoro : EPAR - Summary for the public HU = magyar 2014-10-13  
Velphoro : EPAR - Summary for the public MT = Malti 2014-10-13  
Velphoro : EPAR - Summary for the public NL = Nederlands 2014-10-13  
Velphoro : EPAR - Summary for the public PL = polski 2014-10-13  
Velphoro : EPAR - Summary for the public PT = português 2014-10-13  
Velphoro : EPAR - Summary for the public RO = română 2014-10-13  
Velphoro : EPAR - Summary for the public SK = slovenčina 2014-10-13  
Velphoro : EPAR - Summary for the public SL = slovenščina 2014-10-13  
Velphoro : EPAR - Summary for the public FI = suomi 2014-10-13  
Velphoro : EPAR - Summary for the public SV = svenska 2014-10-13  
Velphoro : EPAR - Summary for the public HR = Hrvatski 2014-10-13  
Name Language First published Last updated
Velphoro : EPAR - Risk-management-plan summary (English only) 2014-10-13  

This EPAR was last updated on 29/09/2016 .

Authorisation details

Product details

Product details for Velphoro
NameVelphoro
Agency product numberEMEA/H/C/002705
Active substance

mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

International non-proprietary name (INN) or common name

mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

Therapeutic area HyperphosphatemiaRenal Dialysis
Anatomical therapeutic chemical (ATC) code V03AE05
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 Velphoro
Marketing-authorisation holder

Vifor Fresenius Medical Care Renal Pharma France

Revision3
Date of issue of marketing authorisation valid throughout the European Union26/08/2014

Contact address:

Vifor Fresenius Medical Care Renal Pharma France
100-101 Terrasse Boieldieu
Tour Franklin- La Défense 8
92042 Paris la Défense Cedex
France

Product information

Product information

05/09/2016  Velphoro -EMEA/H/C/002705 -IB/0007/G

Name Language First published Last updated
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29
Velphoro : EPAR - Product Information EN = English 2014-10-13 2016-09-29

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
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  
Velphoro : EPAR - All Authorised presentations EN = English 2014-10-13  

Pharmacotherapeutic group

Chewable tablet

Therapeutic indication

Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).

Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Velphoro : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-01-28 2016-09-29

Initial marketing-authorisation documents

Name Language First published Last updated
Velphoro : EPAR - Public assessment report EN = English 2014-10-13  
CHMP summary of positive opinion for Velphoro EN = English 2014-06-27  

Authorised

This medicine is approved for use in the European Union