- Approval Id
- 3ac498a04d062925
- Drug Name
- LOKELMA POWDER FOR ORAL SUSPENSION 5G
- Product Name
- LOKELMA POWDER FOR ORAL SUSPENSION 5G
- Approval Number
- SIN15961P
- Approval Date
- 2020-06-22
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- POWDER, FOR SUSPENSION
- Dosage
- **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.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
LOKELMA is indicated for the treatment of hyperkalaemia in adult patients.
- Contraindications
- **4.3 Contraindications**
No contraindications.
- Atc Code
- V03AE10
- Atc Item Name
- sodium zirconium cyclosilicate
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
- Company Detail Path
- /organization/469fa28f5ad70b79/astrazeneca-singapore-pte-ltd
