sodium zirconium cyclosilicate (Lokelma)

following a full submission:

sodium zirconium cyclosilicate (Lokelma®) is accepted for restricted use within NHSScotland.

Indication under review: treatment of hyperkalaemia in adult patients.

SMC restriction: patients with persistent hyperkalaemia (defined as a serum potassium of 5.5 to 6.0 mmol/L) with chronic kidney disease (CKD) stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor (RAASi) therapy to maintain a clinically acceptable serum potassium level (normokalaemia).

Sodium zirconium cyclosilicate, compared with placebo, reduced serum potassium in two and four-week studies in adults with hyperkalaemia. In an uncontrolled one-year study sodium zirconium cyclosilicate supported normal serum potassium in a majority of adults with hyperkalaemia.

SMC has previously issued advice for sodium zirconium cyclosilicate for the treatment of hyperkalaemia (defined as a serum potassium of >6.0mmol/L) in adult patients with CKD stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor therapy to maintain a clinically acceptable serum potassium level (normokalaemia) (SMC2288) and in the emergency care setting for the treatment of acute, life-threatening hyperkalaemia alongside standard care (SMC2515). These pieces of advice are still valid.