Lokelma (sodium zirconium cyclosilicate hydrate)
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 March 2023 |
| First round evaluation completed | 21 September 2023 |
| Second round evaluation completed | 19 December 2023 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 12 January 2024 |
| Advisory Committee meeting | February 2024 |
| Registration decision (Outcome) | 4 April 2024 |
| Completion of administrative activities and registration on ARTG | 9 April 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 206 |
*Statutory timeframe for standard applications is 255 working days
Lokelma contains no other ingredients.
For patients with hyperkalaemia (serum potassium level greater than 5.0 millimoles per litre (mmol/L)), 10g starting dose three times a day. Normokalaemia (potassium levels between 3.5 and 5.0) is achieved within 24 to 48 hours. If the measured serum potassium is still above 5.0 mmol/L at the end of 48 hours, an additional 24 hours of 10 g three times a day dosing may be given, prior to initiation of the maintenance dose. If normokalaemia is not achieved at the end of day three, other treatment approaches should be considered
For more information refer to the Product Information.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
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.
Lokelma is to be included in the Black Triangle Scheme. The PI and CMI for Lokelma must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product. The Lokelma Risk Management Plan (RMP) as agreed with the TGA will be implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, which includes the submission of periodic safety update reports (PSURs).
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.