We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Lokelma (sodium zirconium cyclosilicate hydrate)
Australian Prescription Medicine Decision Summary
Published
Product name
Lokelma
Active ingredient
Sodium zirconium cyclosilicate hydrate
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Lokelma (sodium zirconium cyclosilicate hydrate) was approved for the following therapeutic use: Lokelma is indicated for the treatment of hyperkalaemia (high potassium) in adult patients.
How this medicine works
Lokelma is a crystalline powder that binds potassium. Lokelma binds potassium ions throughout the entire gastrointestinal tract. The trapped potassium ions are excreted from the body via the faeces, thereby reducing any excess and resolving hyperkalaemia (high serum potassium levels).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The clinical development program for Lokelma was initiated in late 2011 and includes four completed multicentre studies and one ongoing long-term study. The benefit-risk profile of Lokelma was considered favourable for the therapeutic use approved.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.