Lokelma

Posology Correction phase The recommended starting dose of Lokelma is 10 g, administered three times a day orally as a suspension in water. When normokalaemia is achieved, the maintenance regimen should be followed (see below). Typically, normokalaemia is achieved within 24 to 48 hours.

If patients are still hyperkalaemic after 48 hours of treatment, the same regimen can be continued for an additional 24 hours. If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered.

Maintenance phase When 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. 4). Missed dose If a patient misses a dose they should be instructed to take the next usual dose at their normal time. 3 Special populations Patients with renal impairment No changes from the normal doses are required for patients with renal impairment who are not on chronic haemodialysis.

For patients on dialysis Lokelma should only be dosed on non-dialysis days. The recommended starting dose is 5 g once daily. 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. g. monthly, or more frequently based on clinical judgement including changes in dietary potassium or medication affecting serum potassium).

Patients with hepatic impairment No changes from the normal doses are required for patients with hepatic impairment. Elderly population No special dose and administration guidelines are recommended for this population. Paediatric population The safety and efficacy of Lokelma in children and adolescents (< 18 years) have not been established.

No data are available. Method of administration For oral use. The entire contents of the sachet(s) should be emptied in a drinking glass containing approximately 45 ml of water and stirred well. The tasteless liquid should be drunk while still cloudy.

7%). 1%)]. These events were mild to moderate in nature, none were reported as serious and were generally resolved while the patient continued treatment. Due to the open label study design, a causal relationship between these events and Lokelma cannot be established.

9% occurred in non-dialysis patients receiving Lokelma; and was resolved with dose adjustment or treatment discontinuation. 7% (12/209) on placebo. 4). Tabulated list of adverse reactions The safety profile of Lokelma was evaluated in clinical trials involving 1 760 patients with 507 patients exposed for one year.

The adverse reactions identified from controlled trials and post-marketing reports are shown in Table 1. Adverse reactions listed below are classified according to frequency and system organ class (SOC).

The following convention was used for frequency of adverse reactions:

Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1 000 to < 1/100); Rare (≥ 1/10 000 to < 1/1 000); Very rare (< 1/10 000); not known (cannot be estimated from the available data). Table 1. 5 mmol/L, which was resolved with dose adjustment or discontinuation of Lokelma.

7% of Lokelma patients. The events were observed in the maintenance phase only and were more commonly seen in patients treated with 15 g. Up to 53% were managed by initiating a diuretic or adjusting a diuretic dose; the remainder did not require treatment.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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.

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. 4 Worsening of pre-existing heart failure 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.

8). 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.

Hypersensitivity to the active substance.