Posology : מינונים

4.2   Posology and method of administration
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.

Serum potassium levels should be monitored regularly during treatment (see section 4.4). Monitoring frequency will depend upon a variety of factors including other medications, progression of chronic kidney disease and dietary potassium intake.

If severe hypokalaemia should occur, Lokelma should be discontinued and the patient re-evaluated.

Missed dose
If a patient misses a dose they should be instructed to take the next usual dose at their normal time.

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. 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 (e.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
Lokelma is not indicated for use in 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. The powder will not dissolve. If the powder settles, the liquid should be stirred again and taken. If needed, rinse the glass with more water to ensure that all of the content is taken.

The suspension can be taken with or without food.