Currently Enrolling Trials
Lokelma (sodium zirconium cyclosilicate) is a highly-selective, oral potassium-removing agent.
Lokelma is specifically indicated for the treatment of hyperkalemia in adults.
Lokelma is supplied as a solution for oral administration. The recommended dose is 10 g administered three times a day for up to 48 hours. Administer Lokelma orally as a suspension in water. For continued treatment, the recommended dose is 10 g once daily. Monitor serum potassium and adjust the dose of Lokelma based on the serum potassium level and desired target range. During maintenance treatment, the dose may be up-titrated based on the serum potassium level at intervals of 1-week or longer and in increments of 5 g. The dose of Lokelma should be decreased or discontinued if the serum potassium is below the desired target range. The recommended maintenance dose range is from 5 g every other day to 15 g daily.
Mechanism of Action
Lokelma (sodium zirconium cyclosilicate) is a highly-selective, oral potassium-removing agent. Lokelma (sodium zirconium cyclosilicate) is a non-absorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium. In vitro, Lokelma has a high affinity for potassium ions, even in the presence of other cations such as calcium and magnesium. Lokelma increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, thereby lowering serum potassium level.
The most common adverse reaction associated with the use of Lokelma is mild to moderate edema.
Clinical Trial Results
The FDA approval of Lokelma was based on data from three double-blind, placebo-controlled trials and two open-label trials, which showed that for patients receiving Lokelma the onset of action was at 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours from baseline. The treatment effect was maintained for up to 12 months.