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Lokelma (sodium zirconium cyclosilicate hydrate)
Australian Prescription Medicine Decision Summary
Sponsor
ARTGs
Device/Product name
Lokelma
Active Ingredient
Sodium zirconium cyclosilicate hydrate
Date of decision
Published
Submission type
New chemical entity
ATC codes
Not yet assigned
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
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
Date of entry onto ARTG
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Powder for oral suspension.
Strength
5g, 10g
Other ingredients
Lokelma contains no other ingredients.
Containers
Sachet
Pack sizes
3 sachets (starter pack), 30 sachets.
Routes of administration
Oral
Dosage
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.
Pregnancy category
B1
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.
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.
What was approved
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.
What is this medicine and how does it work
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).
What post-market commitments will the sponsor undertake
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.