Lokelma Special Precautions

Hypokalaemia: Hypokalaemia may be observed. Dose titration as described under maintenance posology may be required in such cases to prevent moderate to severe hypokalaemia.
Serum potassium levels: In patients with serum potassium levels <3.0 mmol/L, LOKELMA should be discontinued and the patient re-evaluated. Serum potassium should be monitored when clinically indicated for example, if changes are made to medications that affect serum potassium levels (e.g. use of renin-angiotensin-aldosterone system [RAAS] inhibitors or diuretics) and the LOKELMA dose titrated if necessary.
Oedema: Each 5 g dose of LOKELMA contains approximately 400 mg of sodium. In clinical trials of LOKELMA, oedema was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily. Monitor for signs of oedema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (e.g., heart failure or renal disease). Advise patients to adjust dietary sodium, if appropriate. Increase the dose of diuretics as needed.
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.
Limitations of the clinical data: 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: No studies on the effects on the ability to drive and use machines have been performed.