LOKELMA POWDER FOR ORAL SUSPENSION 10G

4.1 Therapeutic indications

LOKELMA is indicated for the treatment of hyperkalaemia in adult patients.

4.3 Contraindications

No contraindications.

4.2 Posology and method of administration

Posology

Use in adults

Treatment of hyperkalaemia correction phase

For patients whose serum potassium level is >5.0 millimoles per litre (mmol/L) the recommended starting dose of LOKELMA is 10 g, administered three times a day (TID) orally as a suspension in water, to achieve normokalaemia (normal potassium levels between 3.5 and 5.0 mmol/L). Typically, normokalaemia is achieved within 24 to 48 hours. If the measured serum potassium is still above 5.0 mmol/L at the end of 48 hours, an additional day (24 hours) of 10 g three times a day dosing may be given, prior to initiation of the maintenance dose. If normokalaemia is not achieved at the end of day 3, other treatment approaches should be considered.

Treatment of hyperkalaemia maintenance phase

For continued maintenance treatment, the minimal effective dose to prevent recurrence of hyperkalaemia should be established. A 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. 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 dose adjustment required for patients with hepatic impairment.

Elderly patients

Dose adjustment is not required in the elderly.

Paediatric patients

Safety and efficacy of LOKELMA in paediatric patients have not been established.

Method of administration

For oral use.

Patients should be instructed to empty the entire contents of the sachet(s) into a drinking glass containing approximately 45 ml of water. Stir well and drink while the powder, which does not dissolve, is still suspended. The suspension is tasteless and will appear as a cloudy liquid. If the powder settles the water should be stirred again. Ensure all product is taken.

LOKELMA can be taken with or without food.