LOKELMA

What it is

LOKELMA is sodium zirconium cyclosilicate hydrate powder for oral suspension. Sodium zirconium cyclosilicate is a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations. LOKELMA is available in 5 gram and 10 gram sachets for oral suspension.

Approved indications

— Treatment of hyperkalaemia in adult patients

Dosing overview

For patients with hyperkalaemia (serum potassium level >5.0 mmol/L), the recommended starting dose of LOKELMA is 10 g, administered three times a day orally as a suspension in water, to achieve normokalaemia (normal potassium levels between 3.5 and 5.0 mmol/L). Typically, normokalaemia is achieved within 24 to 48 hours. For maintenance treatment, a dose of 5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level. No more than 10 g once daily should be used for maintenance therapy.

Key safety warnings

Hypokalaemia (serum potassium level <3.5 mmol/L) may be observed. Dose titration as described under maintenance dose may be required to prevent moderate to severe hypokalaemia. In patients with serum potassium levels <3.0 mmol/L, LOKELMA should be discontinued and the patient re-evaluated. Patients with pre-existing heart failure, particularly those in whom an increased sodium intake may lead to fluid overload and decompensation, should be monitored for manifestations of worsening heart failure. These include increased dyspnoea, oedema and rapid weight gain, and should be managed as per standard clinical practice. LOKELMA may be opaque to X-rays and may therefore affect the interpretation of radiographic results. LOKELMA should not be used alone as an emergency treatment of life-threatening hyperkalaemia, as rapid potassium reduction is not achievable by oral agents. The risk for intestinal perforation with the use of LOKELMA is currently unknown. Since intestinal perforation has been reported with potassium binders including LOKELMA, specific attention should be paid to signs and symptoms related to intestinal perforation. LOKELMA contains approximately 400 mg sodium per 5 g dose, equivalent to 20% of the WHO recommended maximum daily intake of 2 g sodium for an adult. LOKELMA is considered high in sodium.

Contraindications

Hypersensitivity to the active substance.

PBS listing

LOKELMA was recommended by PBAC in March 2024 for chronic hyperkalaemia in patients with chronic kidney disease (CKD) Stage 3-4. Two strengths are registered on the ARTG: 5 gram and 10 gram powder for oral suspension sachets, both first listed on 9 April 2024.

Regulatory history

LOKELMA sodium zirconium cyclosilicate hydrate 5 gram and 10 gram powder for oral suspension sachets were first registered on the ARTG on 9 April 2024. The product received PBAC recommendation in March 2024 for chronic hyperkalaemia in patients with chronic kidney disease Stage 3-4.