Potassium Binder Dosing Regimen for HD Patients Receives FDA Approval

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The FDA has accepted a label replace for the oral potassium binder sodium zirconium cyclosilicate (Lokelma) to incorporate a dosing routine to deal with hyperkalemia in sufferers on hemodialysis (HD).

In accordance with the replace, clinicians ought to use a beginning
dose of 5 g as soon as each day on non-dialysis days. In sufferers with serum potassium ranges
increased than 6.5 mmol/L, they need to think about a beginning dose of 10 g as soon as each day
on nondialysis days and discontinue the medicine if predialysis serum
potassium after the lengthy interdialytic interval falls under goal vary or
hypokalemia develops.

That is the first label update for Lokelma within the US following its FDA approval in 2018. The brand new dosing routine for HD sufferers was primarily based on outcomes of the phase 3b DIALIZE trial during which considerably extra sufferers taking sodium zirconium cyclosilicate than placebo maintained serum potassium inside four to five mmol/L throughout no less than three of four HD classes after the lengthy interdialytic interval of the final four weeks of remedy and didn’t want rescue remedy: 41.2% vs 1.0%.

The commonest hostile response with sodium zirconium
cyclosilicate was gentle to reasonable edema. Sufferers with extreme constipation,
bowel obstruction, or impaction mustn’t obtain the medicine. In accordance with
the present label, sodium zirconium cyclosilicate shouldn’t be used as an
emergency remedy for life-threatening hyperkalemia due to its delayed
onset of motion.

“Greater than 500,000 sufferers within the US live with
dialysis-dependent end-stage renal illness and might be in danger for dangerously
excessive ranges of potassium,” Mene Pangalos, government vp of AstraZeneca’s
BioPharmaceuticals R&D, said in a information launch. “With this FDA accepted
replace, the Lokelma label now contains necessary dosing steering for treating
hyperkalaemia in sufferers on haemodialysis.”

Reference

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.





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