What is the treatment protocol for hyperkalemia using Lokelma (sodium zirconium cyclosilicate)?

From the Guidelines

Lokelma (sodium zirconium cyclosilicate) should be administered for hyperkalemia treatment in a two-phase approach, with an initial correction phase of 10 grams three times daily for up to 48 hours, followed by a maintenance phase of 5-15 grams once daily, as indicated in the study published in the Mayo Clinic Proceedings 1.

Key Considerations for Lokelma Administration

• The medication should be mixed as a suspension in approximately 3 tablespoons of water, stirred well, and consumed immediately.
• For patients on dialysis, Lokelma should be given on non-dialysis days.
• Lokelma works by selectively capturing potassium ions in the gastrointestinal tract through ion-exchange mechanisms, preventing absorption and facilitating elimination through feces.
• This non-systemic mechanism makes it suitable for patients with kidney impairment.

Monitoring and Side Effects

• Common side effects include edema and hypokalemia, so regular potassium monitoring is essential.
• Lokelma should not replace emergency measures for severe, life-threatening hyperkalemia but serves as part of a comprehensive management approach alongside dietary potassium restriction and addressing underlying causes.

Clinical Context and Recommendations

• According to the expert consensus document on the management of hyperkalaemia in patients with cardiovascular disease treated with renin angiotensin aldosterone system inhibitors, published in the European Heart Journal 1, Lokelma is a recommended treatment option for hyperkalemia.
• The study highlights the importance of regular potassium monitoring and the need for a comprehensive management approach to address underlying causes of hyperkalemia.

From the FDA Drug Label

LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults. Recommended starting dose is 10 g administered three times a day for up to 48 hours. For maintenance treatment, recommended dose is 10 g once daily. Patients on Chronic Hemodialysis Recommended starting dose is 5 g once daily on non-dialysis days.

The treatment protocol for hyperkalemia using Lokelma (sodium zirconium cyclosilicate) is as follows:

• Initial Treatment: 10 g administered three times a day for up to 48 hours.
• Maintenance Treatment: 10 g once daily, with dose adjustments at one-week intervals as needed (by 5 g daily) to obtain desired serum potassium target range.
• Patients on Chronic Hemodialysis: 5 g once daily on non-dialysis days 2. Key Considerations:
• Dose Adjustment: Adjust dose at one-week intervals as needed to obtain desired serum potassium target range.
• Administration: Other oral medications should be administered at least 2 hours before or 2 hours after LOKELMA.

From the Research

Treatment Protocol for Hyperkalemia using Lokelma (Sodium Zirconium Cyclosilicate)

• Lokelma (sodium zirconium cyclosilicate) is a nonabsorbable, inorganic crystal that selectively binds potassium and ammonium in exchange for Na+ and H+ in the whole gastrointestinal tract 3.
• It is used to treat hyperkalemia, a common electrolyte disturbance that can occur in patients with chronic kidney disease, diabetes, or heart failure 3.
• The treatment protocol for hyperkalemia using Lokelma typically involves an initial dose of 10 g three times daily for 48 hours, followed by a maintenance dose of 5-15 g daily 4.
• The efficacy and safety of Lokelma have been demonstrated in several clinical trials, including the HARMONIZE randomized clinical trial, which showed that Lokelma reduced serum potassium levels to normal levels within 48 hours and maintained normokalemia for up to 28 days 4.

Dosage and Administration

• The recommended dosage of Lokelma is 10 g three times daily for 48 hours, followed by a maintenance dose of 5-15 g daily 4.
• Lokelma should be administered orally, preferably with food, to minimize gastrointestinal adverse events 3.
• The dose of Lokelma may need to be adjusted based on the patient's serum potassium levels and clinical response 4.

Safety and Adverse Events

• Common adverse events associated with Lokelma include gastrointestinal events, such as constipation, diarrhea, and nausea, as well as a dose-dependent risk of edema 3, 4.
• Hypokalemia has also been reported in some patients taking Lokelma, particularly at higher doses 4.
• Lokelma has a low potential for drug interactions, making it a suitable option for patients taking multiple medications 3.