Abridged Prescribing Information
LOKELMA (Sodium zirconium cyclosilicate)

Composition: Lokelma powder for oral suspension is available as 5 g or 10 g sachets. Each sachet contains 5 g or 10 g sodium zirconium cyclosilicate. Therapeutic Indications: Treatment of hyperkalaemia in adult patients. Dosage and Administration: Lokelma should not replace emergency treatment for life threatening hyperkalaemia. Lokelma is not systemically absorbed, starts to reduce serum potassium 1 hour after administration, and is eliminated via the faeces. Adults (including elderly): Correction phase: 10 g administered three times daily orally as a suspension in water until normokalaemia is achieved. If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered. Maintenance phase: Once normokalaemia has been achieved, the minimal effective dose of Lokelma to prevent recurrence of hyperkalaemia should be established. A starting 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. Serum potassium levels should be monitored regularly during treatment. If severe hypokalaemia should occur, Lokelma should be discontinued and the patient re-evaluated. Chronic Haemodialysis: Dosed on non-dialysis days. The recommended starting dose is 5 g once daily. To establish normokalaemia (4.0-5.0 mmol/L), the dose may be titrated up or down weekly based on the pre-dialysis serum potassium value after the long inter-dialytic interval (LIDI). The dose could be adjusted at intervals of one week in increments of 5 g up to 15 g once daily on non-dialysis days. It is recommended to monitor serum potassium weekly while the dose is adjusted; once normokalaemia is established, potassium should be monitored regularly. Missed dose: Take the next usual dose at the normal time. Method of administration: For oral use only. The entire contents of the sachet should be mixed with approximately 45 ml of water, stirred well and taken immediately. The powder will not dissolve. If the powder settles, the solution should be stirred again. It should be ensured that all the content is taken. The suspension can be taken with or without food. Contraindications: Hypersensitivity to the active substance. Warnings and Precautions: Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium levels (e.g. renin-angiotensin-aldosterone system (RAAS) inhibitors or diuretics) and after the Lokelma dose is titrated. Hypokalaemia: Hypokalaemia may be observed. Dose titration as described under maintenance posology may be required. QT prolongation: During correction of hyperkalaemia, a lengthening of the QT interval can be observed as the physiologic result of a decline in serum potassium levels. X-rays: Lokelma may be opaque to X-rays. Intestinal perforation: 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. Long-term exposure: Clinical trials with Lokelma have not included exposure longer than one year. Drug interaction: Lokelma is not absorbed or metabolised by the body and does not meaningfully bind other medicinal products. Lokelma can transiently increase gastric pH by absorbing hydrogen ions and can lead to changes in solubility and absorption kinetics for co-administered medicinal products with pH-dependent bioavailability. It is recommended that Lokelma be administered at least 2 hours before or after such medicinal products. Co-administration of Lokelma 15 g with tacrolimus 5 mg resulted in a decreased tacrolimus AUC and Cmax. Therefore, tacrolimus should be taken at least 2 hours before or after Lokelma. Adverse reactions: Commonly reported adverse reactions were hypokalaemia (4.1%), oedema related events (5.7%), constipation (8.9%). Overdosage: Overdose could lead to hypokalaemia. Dose titration as described under maintenance posology may be required. Special populations: Patients on dialysis: Lokelma has not been studied in patients receiving dialysis treatment. Severe hyperkalaemia: There is limited experience in patients with serum potassium levels > 6.5 mmol/L. Pregnancy: There is no data from the use of Lokelma in pregnant women. Breast-feeding: Lokelma can be used during breast-feeding. Storage: Store at or below 30˚C. Full local prescribing information is available upon request. API.HK.LOK.0624​

HK-13222 22/07/2026