Parsabiv

etelcalcetide

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

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

What is Parsabiv and what is it used for?

Parsabiv is a medicine used to reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism). Parathyroid hormone is produced by the parathyroid glands in the neck and regulates calcium and phosphate levels. High levels of parathyroid hormone can cause loss of calcium from the bones, bone pain and fractures, and heart and circulation problems.

Parsabiv is used in patients on haemodialysis (a technique for removing waste products from the blood using a blood filtration machine). It contains the active substance etelcalcetide.

How is Parsabiv used?

Parsabiv is available as a solution for injection. Treatment is started at a dose of 5 mg three times a week and the dose is then adjusted according to the patient’s parathyroid hormone level or calcium level. It is given at the end of a haemodialysis session into the line that leads back from the dialysis machine to the patient’s vein. In some circumstances, it can be given by injection into a vein.

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

How does Parsabiv work?

When cells in the parathyroid gland detect high levels of calcium in the blood, they reduce the amount of parathyroid hormone entering the blood. The active substance in Parsabiv, etelcalcetide, is a calcimimetic. This means that it mimics the action of calcium on these cells and in this way, it reduces the parathyroid hormone levels in the blood. Reduced parathyroid hormone decreases the levels of calcium in the blood.

What benefits of Parsabiv have been shown in studies?

Parsabiv has been investigated in three main studies involving 1,706 patients on haemodialysis who had long-term kidney disease and secondary hyperparathyroidism. The first two studies compared Parsabiv with placebo (a dummy treatment), and the third study compared it with cinacalcet, another calcimimetic medicine. In all three studies, Parsabiv was given for 26 weeks. The main measure of effectiveness was a reduction in parathyroid hormone by more than 30% after at least 20 weeks of treatment.

In the first two studies, Parsabiv was effective in 75% (380 out of 509) of patients compared with 9% (46 out of 514) of patients given placebo. In the third study, Parsabiv was found to be at least as effective as cinacalcet: in 68% (232 out of 340) patients given Parsabiv compared with 58% (198 out of 343) patients given cinacalcet.

What are the risks associated with Parsabiv?

The most common side effects with Parsabiv (which may affect more than 1 in 10 people) are low calcium level in the blood, muscle spasm, diarrhoea, nausea (feeling sick) and vomiting.

Parsabiv must not be started if the patient’s blood calcium level is below the normal range. For the full list of Parsabiv’s side effects and restrictions, see the package leaflet.

Why is Parsabiv approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Parsabiv’s benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been found effective for reducing parathyroid hormone in the blood in patients with kidney disease being treated with haemodialysis and its side effects are those expected of a calcimimetic substance.

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

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

Other information about Parsabiv

The European Commission granted a marketing authorisation valid throughout the European Union for Parsabiv on 11 November 2016. For more information about treatment with Parsabiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Parsabiv : EPAR - Summary for the public BG = bălgarski 2016-11-24  
Parsabiv : EPAR - Summary for the public ES = español 2016-11-24  
Parsabiv : EPAR - Summary for the public CS = čeština 2016-11-24  
Parsabiv : EPAR - Summary for the public DA = dansk 2016-11-24  
Parsabiv : EPAR - Summary for the public DE = Deutsch 2016-11-24  
Parsabiv : EPAR - Summary for the public ET = eesti keel 2016-11-24  
Parsabiv : EPAR - Summary for the public EL = elliniká 2016-11-24  
Parsabiv : EPAR - Summary for the public EN = English 2016-11-24  
Parsabiv : EPAR - Summary for the public FR = français 2016-11-24  
Parsabiv : EPAR - Summary for the public IT = italiano 2016-11-24  
Parsabiv : EPAR - Summary for the public LV = latviešu valoda 2016-11-24  
Parsabiv : EPAR - Summary for the public LT = lietuvių kalba 2016-11-24  
Parsabiv : EPAR - Summary for the public HU = magyar 2016-11-24  
Parsabiv : EPAR - Summary for the public MT = Malti 2016-11-24  
Parsabiv : EPAR - Summary for the public NL = Nederlands 2016-11-24  
Parsabiv : EPAR - Summary for the public PL = polski 2016-11-24  
Parsabiv : EPAR - Summary for the public PT = português 2016-11-24  
Parsabiv : EPAR - Summary for the public RO = română 2016-11-24  
Parsabiv : EPAR - Summary for the public SK = slovenčina 2016-11-24  
Parsabiv : EPAR - Summary for the public SL = slovenščina 2016-11-24  
Parsabiv : EPAR - Summary for the public FI = suomi 2016-11-24  
Parsabiv : EPAR - Summary for the public SV = svenska 2016-11-24  
Parsabiv : EPAR - Summary for the public HR = Hrvatski 2016-11-24  

This EPAR was last updated on 24/11/2016 .

Authorisation details

Product details

Product details for Parsabiv
NameParsabiv
Agency product numberEMEA/H/C/003995
Active substance

etelcalcetide hydrochloride

International non-proprietary name (INN) or common name

etelcalcetide

Therapeutic area Hyperparathyroidism, Secondary
Anatomical therapeutic chemical (ATC) code H05BX04
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 Parsabiv
Marketing-authorisation holder

Amgen Europe B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union11/11/2016

Contact address:

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda 
Netherlands

Product information

Product information

11/11/2016  Parsabiv -EMEA/H/C/003995 --

Name Language First published Last updated
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - Product Information HR = Hrvatski 2016-11-24  

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
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  
Parsabiv : EPAR - All Authorised presentations HR = Hrvatski 2016-11-24  

Pharmacotherapeutic group

Calcium homeostasis, anti-parathyroid agents

Therapeutic indication

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Parsabiv : EPAR - Public assessment report HR = Hrvatski 2016-11-24  
CHMP summary of positive opinion for Parsabiv HR = Hrvatski 2016-09-16