Hyperkalemia Treatment Lokelma Gets FDA Approval
The Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate; AstraZeneca) for the treatment of hyperkalemia in adults.
Lokelma is a non-absorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium. It increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract; this reduces the concentration of free potassium and lowers serum potassium levels.
The approval of Lokelma was based on several clinical trials in patients with hyperkalemia. In one 2-part, double-blind, randomized, placebo-controlled trial (N=753), a greater reduction in serum potassium levels was observed in Lokelma-treated patients compared with placebo (2.5g 3 times daily [TID]: -0.5; 5g TID: -0.5; 10g TID: -0.7 vs placebo:-0.2; P<.001). Lokelma was found to be effective at lowering potassium levels in patients with chronic kidney disease, heart failure, diabetes, and those taking renin-angiotensin-aldosterone system inhibitors. In an open-label 12-month study (N=751), 99% of patients treated with Lokelma 10g TID achieved normokalemia within 72 hours.
In clinical trials, the most common adverse reaction with Lokelma was mild to moderate edema (6%). No overall differences in safety or effectiveness were seen between patients ≥65 years old and younger patients.
Lokelma should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. For patients with severe constipation and bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, treatment should be avoided as Lokelma has not been studied in patients with these conditions.
Lokelma is supplied as a white powder in 5g and 10g packets for reconstitution into an oral suspension. In general, other oral medications should be taken ≥2 hours before or 2 hours after Lokelma.
For more information visit AstraZeneca.com.