LOKELMA POWDER FOR ORAL SUSPENSION 10G

ASTRAZENECA SINGAPORE PTE LTD

ASTRAZENECA SINGAPORE PTE LTD

Therapeutic

Prescription Only

POWDER, FOR SUSPENSION

**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.