Lokelma

sodium zirconium cyclosilicate

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

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

What is Lokelma and what is it used for?

Lokelma is a medicine used to treat hyperkalaemia (high levels of potassium in the blood) in adults. It contains the active substance sodium zirconium cyclosilicate.

How is Lokelma used?

Lokelma is available as powder sachets (5 g and 10 g). The powder is stirred into water to make a mixture to be drunk straight away. The recommended starting dose of Lokelma is 10 g three times a day. Once the blood levels of potassium return within the normal range (usually within 1–2 days), patients should take the lowest effective dose of Lokelma to prevent the return of hyperkalaemia, starting with 5 g once a day and not exceeding 10 g once a day. For further information, see the package leaflet.

The medicine can only be obtained with a prescription.

How does Lokelma work?

The active substance in Lokelma, sodium zirconium cyclosilicate, is a potassium binder. When taken by mouth, Lokelma attaches to potassium from food and body fluids in the gut, forming a compound that is then eliminated in the stools. This action removes potassium from the body overall, thus helping to lower the potassium levels in the blood.

What benefits of Lokelma have been shown in studies?

Lokelma is effective at lowering blood potassium levels and keeping levels of potassium within the normal range.

In a main study of 754 patients with hyperkalaemia, 86% of patients taking Lokelma 10 g had normal potassium levels after 2 days compared with 48% of those taking placebo (a dummy treatment). In addition, when patients who had normal potassium levels after Lokelma treatment were given further treatment with either Lokelma or placebo, potassium levels stayed normal for longer with Lokelma than with placebo.

Another main study involved 258 patients who had normal potassium levels after Lokelma treatment. In this 4-week study, patients receiving further treatment with Lokelma had lower potassium levels from the second week of treatment than patients taking placebo.

What are the risks associated with Lokelma?

The most common side effects with Lokelma (which may affect up to 1 in 10 people) are oedema (fluid build-up with swelling in the ankles and feet) and hypokalaemia (low levels of potassium in the blood).

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

Why is Lokelma approved?

The European Medicines Agency decided that Lokelma’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that Lokelma is effective at controlling blood potassium levels, especially during initial (acute) treatment. The overall safety profile is considered acceptable.

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

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

Other information about Lokelma

The European Commission granted a marketing authorisation valid throughout the European Union for Lokelma on 22 March 2018.

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

Name Language First published Last updated
Lokelma : EPAR - Summary for the public BG = bălgarski 2018-04-05  
Lokelma : EPAR - Summary for the public ES = español 2018-04-05  
Lokelma : EPAR - Summary for the public CS = čeština 2018-04-05  
Lokelma : EPAR - Summary for the public DA = dansk 2018-04-05  
Lokelma : EPAR - Summary for the public DE = Deutsch 2018-04-05  
Lokelma : EPAR - Summary for the public ET = eesti keel 2018-04-05  
Lokelma : EPAR - Summary for the public EL = elliniká 2018-04-05  
Lokelma : EPAR - Summary for the public EN = English 2018-04-05  
Lokelma : EPAR - Summary for the public FR = français 2018-04-05  
Lokelma : EPAR - Summary for the public IT = italiano 2018-04-05  
Lokelma : EPAR - Summary for the public LV = latviešu valoda 2018-04-05  
Lokelma : EPAR - Summary for the public LT = lietuvių kalba 2018-04-05  
Lokelma : EPAR - Summary for the public HU = magyar 2018-04-05  
Lokelma : EPAR - Summary for the public MT = Malti 2018-04-05  
Lokelma : EPAR - Summary for the public NL = Nederlands 2018-04-05  
Lokelma : EPAR - Summary for the public PL = polski 2018-04-05  
Lokelma : EPAR - Summary for the public PT = português 2018-04-05  
Lokelma : EPAR - Summary for the public RO = română 2018-04-05  
Lokelma : EPAR - Summary for the public SK = slovenčina 2018-04-05  
Lokelma : EPAR - Summary for the public SL = slovenščina 2018-04-05  
Lokelma : EPAR - Summary for the public FI = suomi 2018-04-05  
Lokelma : EPAR - Summary for the public SV = svenska 2018-04-05  
Lokelma : EPAR - Summary for the public HR = Hrvatski 2018-04-05  

This EPAR was last updated on 05/04/2018 .

Authorisation details

Product details

Product details for Lokelma
NameLokelma
Agency product numberEMEA/H/C/004029
Active substance

sodium zirconium cyclosilicate

International non-proprietary name (INN) or common name

sodium zirconium cyclosilicate

Therapeutic area Hyperkalemia
Anatomical therapeutic chemical (ATC) code V03AE10
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 Lokelma
Marketing-authorisation holder

AstraZeneca AB

Revision0
Date of issue of marketing authorisation valid throughout the European Union22/03/2018

Contact address:

SE-15185 Sodertalje
Sweden

Product information

Product information

22/03/2018  Lokelma -EMEA/H/C/004029 --

Name Language First published Last updated
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  
Lokelma : EPAR - Product Information HR = Hrvatski 2018-04-05  

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
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  
Lokelma : EPAR - All Authorised presentations HR = Hrvatski 2018-04-05  

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Lokelma is indicated for the treatment of hyperkalaemia in adult patients.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Lokelma : EPAR - Public assessment report HR = Hrvatski 2018-04-05  
CHMP summary of positive opinion for Lokelma HR = Hrvatski 2017-02-24 2018-01-26