The FDA has approved a label update for the oral potassium binder sodium zirconium cyclosilicate (Lokelma) to include a dosing regimen to treat hyperkalemia in patients on hemodialysis (HD).
According to the update, clinicians should use a starting dose of 5 g once daily on non-dialysis days. In patients with serum potassium levels higher than 6.5 mmol/L, they should consider a starting dose of 10 g once daily on nondialysis days and discontinue the medication if predialysis serum potassium after the long interdialytic interval falls below target range or hypokalemia develops.
This is the first label update for Lokelma in the US following its FDA approval in 2018. The new dosing regimen for HD patients was based on results of the phase 3b DIALIZE trial in which significantly more patients taking sodium zirconium cyclosilicate than placebo maintained serum potassium within 4 to 5 mmol/L during at least 3 of 4 HD sessions after the long interdialytic interval of the last 4 weeks of treatment and did not need rescue therapy: 41.2% vs 1.0%.
The most common adverse reaction with sodium zirconium cyclosilicate was mild to moderate edema. Patients with severe constipation, bowel obstruction, or impaction should not receive the medication. According to the current label, sodium zirconium cyclosilicate should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
“More than 500,000 patients in the US are living with dialysis-dependent end-stage renal disease and could be at risk for dangerously high levels of potassium,” Mene Pangalos, executive vice president of AstraZeneca’s BioPharmaceuticals R&D, stated in a news release. “With this FDA approved update, the Lokelma label now includes important dosing guidance for treating hyperkalaemia in patients on haemodialysis.”
Lokelma US label updated to include dosing guidance for the treatment of hyperkalaemia in patients with end-stage renal disease on haemodialysis [news release]. AstraZeneca; April 27, 2020.