LOKELMA: A New Treatment for Hyperkalemia in Adults

Hyperkalemia, a condition characterized by high potassium levels in the blood, affects 2 to 3% of the general population and 1 to 10% of hospitalized patients. LOKELMA (sodium zirconium cyclosilicate) offers a new approach to managing this potentially life-threatening condition in adults.

How LOKELMA Works

LOKELMA is a prescription medication containing sodium zirconium cyclosilicate, a selective cation exchanger. This means it works by binding to potassium in the gastrointestinal (GI) tract, preventing its absorption into the body. The bound potassium is then eliminated through bowel movements.

Clinical Evidence and Benefit

Data from four evaluation studies – ZS-003 versus placebo, ZS-004 (non-comparative), ZS-005 (non-comparative), and DIALIZE versus placebo – and an extension study (ZS004E) have demonstrated LOKELMA’s effectiveness. The Transparency Commission (CT) analysis, conducted on April 24, 2024, showed that LOKELMA is effective in reducing and normalizing serum potassium levels during the correction phase and preventing hyperkalemia recurrence during the maintenance phase.

Although generally well-tolerated, LOKELMA is associated with frequent adverse events related to edema (fluid retention). The CT noted that the tasteless nature of the medication and the absence of sorbitol in its composition may improve patient compliance and tolerance. However, a direct comparison to other cation exchange resins has not been conducted.

The CT concluded that LOKELMA provides a significant actual benefit (SMR) for its approved indication and a minor improvement in actual benefit (ASMR IV) within the current therapeutic strategy for managing hyperkalemia in adults, establishing it as a first-line treatment option.

How to Seize LOKELMA

LOKELMA is available as a powder that must be mixed with water:

• Pour the contents of one sachet into approximately 45 mL of water and stir thoroughly.
• The resulting mixture is tasteless and should be consumed while cloudy, as the powder does not dissolve.
• If a powder deposit remains, stir again and rinse the glass with additional water to ensure complete consumption.

LOKELMA can be taken with or without food, but it’s best to take it consistently at the same time each day.

Dosage

There are two phases of treatment:

Correction of Hyperkalemia

The recommended starting dose is 10 g three times a day (one 10g sachet three times daily).

Maintenance Therapy

Once normal potassium levels are achieved, maintenance dosage aims to prevent recurrence:

• Start with 5 g once a day, potentially increasing to 10 g once a day or decreasing to 5 g every other day, as needed, to maintain normal potassium levels.
• The daily maintenance dose should not exceed 10 g.

Normokalemia is typically reached within 24 to 48 hours. If hyperkalemia persists after 48 hours, the same dosage can be continued for another 24 hours. If normokalemia isn’t achieved after 72 hours, alternative therapies should be considered.

Dosage adjustments are necessary for patients undergoing hemodialysis.

Significant Considerations

• Regular monitoring of serum potassium levels is crucial during treatment.
• Mix LOKELMA only with plain water; avoid sparkling water.
• LOKELMA can affect the absorption of certain medications, including tacrolimus, antifungals, anti-HIV antivirals, and tyrosine kinase inhibitors. Allow a 2-hour gap between taking LOKELMA and these medications.
• Consult a doctor if you experience fatigue, muscle weakness, cramps, edema (swelling in the feet and ankles), or constipation.

Available Formulations and Cost

LOKELMA is available in the following formulations:

• LOKELMA 5 g, box of 30 sachets (CIP 3400930148075, €188.98)
• LOKELMA 10 g, box of 3 sachets (CIP 3400930148099, €19.17)
• LOKELMA 10 g, box of 30 sachets (CIP 3400930148105, €188.98)

It is 65% reimbursable and approved for community utilize.