AstraZeneca Gets Nod to Update Lokelma for Hyperkalemia

The Subject Expert Committee (SEC) which is under the Central Drugs Standard Control Organization (CDSCO) has given the green signal to AstraZeneca India Pharma Limited’s application of Sodium Zirconium Cyclosilicate Powder for Oral Suspension (marketed as Lokelma) 5 g and 10 g to update the prescribing information.

The approved changes in the information were made gradually across the different sections of the drug leaflet: posology and method of administration, special warnings and precautions, undesirable side effects, adverse reaction listings, and pharmacodynamic effects. The amendment relates to version 2 of the prescribing information (dated April 24, 2025), in accordance with CDS version 8 (December 2024).

AstraZeneca's Lokelma is an insoluble, non-absorbed sodium zirconium silicate product that is a highly selective potassium binder. It is used to treat hyperkalemia i.e. abnormally high potassium levels in the blood, which is a frequent occurrence in patients with chronic kidney disease and heart failure. If the situation is left untreated, it can cause the heart to fail and even lead to the patient's death.

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The medicine binds potassium ions released from food along the gastrointestinal tract, thereby decreasing serum potassium concentration and increasing fecal potassium excretion. Even in the presence of other cations such as calcium and magnesium, its selectivity is not compromised.

In the end, the SEC’s renal expert panel was convinced by the evidence provided by AstraZeneca and gave a nod to the company for the updated Lokelma prescribing information, thus further consolidating its leadership in hyperkalemia therapy.