AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment

This came after the firm presented a proposal for updating the prescribing information version 2, dated 24.04.2025 for the drug product Sodium Zirconium Cyclosilicate Powder for Oral Suspension 5 gm/10 gm as per CDS version 8, dated Dec 2024 before the committee.

Sodium zirconium cyclosilicate is approved as the trade product Lokelma developed by AstraZeneca—an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension that acts as a highly selective potassium-removing agent.

Sodium zirconium cyclosilicate is a potassium binder indicated for the treatment of hyperkalemia in adult patients.

Sodium zirconium cyclosilicate is subsequently a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations.

Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations such as calcium and magnesium, in vitro. Sodium zirconium cyclosilicate captures potassium throughout the entire gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels and increasing fecal potassium excretion to resolve hyperkalemia.

At the recent SEC meeting for renal, the expert panel reviewed the proposal for updating the prescribing information version 2, dated 24.04.2025 for the drug product Sodium Zirconium Cyclosilicate Powder for Oral Suspension 5 gm/10 gm as per CDS version 8, dated Dec 2024.

After detailed deliberation, the Committee recommended the grant of approval for the proposed update in prescribing information as presented by the firm.