AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for AstraZeneca India Pharma Limited's proposal to update the prescribing information for Sodium Zirconium Cyclosilicate Powder for Oral Suspension (marketed as Lokelma) in 5 g and 10 g strengths.
The key changes in the proposed prescribing information are related to editorial changes in the posology and method of administration, special warnings and precautions for use, undesirable side effects, the list of adverse reactions and pharmacodynamic effects, etc.
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.
Hyperkalemia is a condition defined by elevated potassium levels in the blood, often caused by cardiovascular, renal, and metabolic diseases. Hyperkalemia occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure and may lead to cardiac arrest and death.
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.
