LOKELMA Powder for oral suspension Ref.[10414] Active ingredients: Sodium zirconium cyclosilicate

2.1 Recommended Dosage

For initial treatment of hyperkalemia, the recommended dose of LOKELMA is 10 g administered three times a day for up to 48 hours. Administer LOKELMA orally as a suspension in water [see Dosage and Administration (2.3)].

For continued treatment, the recommended dose is 10 g once daily. Monitor serum potassium and adjust the dose of LOKELMA based on the serum potassium level and desired target range. During maintenance treatment, up-titrate based on the serum potassium level at intervals of 1-week or longer and in increments of 5 g. Decrease the dose of LOKELMA or discontinue if the serum potassium is below the desired target range. The recommended maintenance dose range is from 5 g every other day to 15 g daily.

2.2 Dosage Adjustment for Patients on Chronic Hemodialysis

For patients on chronic hemodialysis, administer LOKELMA only on non-dialysis days.

The recommended starting dose is 5 g once daily on non-dialysis days. Consider a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mEq/L. Monitor serum potassium and adjust the dose of LOKELMA based on the pre-dialysis serum potassium value after the long inter-dialytic interval and desired target range.

During initiation and after a dose adjustment, assess serum potassium after one week. The recommended maintenance dose range is from 5 g to 15 g once daily, on non-dialysis days.

Discontinue or decrease the dose of LOKELMA if:

• serum potassium falls below the desired target range based on the pre-dialysis value after the long interdialytic interval, or;
• the patient develops clinically significant hypokalemia

2.3 Reconstitution and Administration

In general, other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA [see Drug Interactions (7)].

Instruct patients to empty the entire contents of the packet(s) into a drinking glass containing approximately 3 tablespoons of water or more if desired. Stir well and drink immediately. If powder remains in the drinking glass, add water, stir and drink immediately. Repeat until no powder remains to ensure the entire dose is taken.

Store LOKELMA at 15°C-30°C (59°F-86°F).