Lokelma Special Precautions

Serum potassium levels: Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. renin-angiotensin-aldosterone system (RAAS) inhibitors or diuretics) and after the Lokelma dose is titrated.
Hypokalaemia: Hypokalaemia may be observed (see Adverse Reactions). Dose titration as described under maintenance posology may be required in such cases to prevent moderate to severe hypokalaemia. In patients with severe hypokalaemia, Lokelma should be discontinued and the patient re-evaluated.
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 concentration.
The risk of interaction with X-rays: Sodium zirconium cyclosilicate may be opaque to X-rays. If the patient is having abdominal X-rays, radiographers should keep this in mind.
Intestinal perforation: The risk for intestinal perforation with the use of Lokelma is currently unknown. No events of intestinal perforation have been reported with Lokelma. Since intestinal perforation has been reported with polymers that act in the gastrointestinal tract, specific attention should be paid to signs and symptoms related to intestinal perforation.
Limitations of the clinical data: Patients on dialysis: Lokelma has not been studied in patients receiving dialysis treatment.
Severe hyperkalaemia: There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L.
Long-term exposure: Clinical trials with Lokelma have not included exposure longer than one year.
Effects on ability to drive and use machines: Lokelma has no or negligible influence on the ability to drive and use machines.