Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

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.

Monitoring frequency will depend upon a variety of factors including other medicinal products, progression of chronic kidney disease and dietary potassium intake.

Hypokalaemia
Hypokalaemia may be observed (see section 4.8). 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. Since intestinal perforation has been reported with potassium binders including Lokelma, specific attention should be paid to signs and symptoms related to intestinal perforation.

Sodium content
This medicinal product 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. This should be particularly taken into account for those on a low salt diet.

Effects on Driving

4.7   Effects on ability to drive and use machines

Lokelma has no or negligible influence on the ability to drive and use machines.