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Lokelma Full Prescribing Information, Dosage & Side Effects
Accurate and comprehensive medication information is essential for effective patient care, particularly for healthcare professionals making prescribing decisions. This article provides detailed prescribing information, dosage guidelines, and potential side effects for Lokelma, a medication indicated for hyperkalemia treatment.
What is Lokelma?
Lokelma (sodium zirconium cyclosilicate) is a potassium-binding agent used to treat hyperkalemia – a potentially serious condition characterized by elevated blood potassium levels that may lead to cardiac arrhythmias and muscle weakness. The medication works by binding potassium in the gastrointestinal tract, reducing its absorption and promoting elimination through feces.
Full Prescribing Information
Healthcare providers should thoroughly review the complete prescribing information before administering Lokelma, including indications, contraindications, warnings, precautions, and proper dosing protocols.
Indications
Lokelma is approved for hyperkalemia treatment in adults. Pediatric use is not recommended due to insufficient safety and efficacy data in this population.
Contraindications
Lokelma is contraindicated in:
- Patients with known hypersensitivity to sodium zirconium cyclosilicate or formulation components
- Individuals with bowel obstruction
- Patients with history of bowel perforation
Warnings and Precautions
Important considerations include:
- Edema: Monitor for fluid overload, particularly in heart failure patients
- Hypokalemia: Risk increases with excessive dosing or in patients with normal/low potassium levels – regular potassium monitoring required
- GI Effects: May cause nausea, vomiting, or diarrhea – monitor and manage symptoms appropriately
Dosage and Administration
The standard initial regimen is 10g orally three times daily for up to 48 hours, with subsequent adjustments based on serum potassium levels. The powder should be mixed with water and consumed immediately (not stored). May be taken with or without food.
Side Effects
Common adverse effects (typically mild-moderate) include:
- Edema
- Diarrhea
- Nausea
- Vomiting
- Hypokalemia
Most reactions resolve without treatment discontinuation. Patients should contact their provider if symptoms persist or worsen. Rare but serious allergic reactions require immediate medical attention (difficulty breathing, facial/throat swelling, rash).
Case Studies and Statistics
Clinical evidence demonstrates Lokelma’s efficacy:
- A NEJM study reported median potassium normalization within 2.2 hours
- In CKD patients with hyperkalemia, Lokelma showed superior potassium reduction versus placebo
- Adverse reactions occurred in <5% of trial participants (edema, diarrhea, nausea, hypokalemia most common)
Summary
Lokelma (sodium zirconium cyclosilicate) effectively manages hyperkalemia by GI potassium binding. Healthcare providers must review complete prescribing information before use, including contraindications and monitoring requirements. While generally well-tolerated, potential side effects include edema, GI symptoms, and hypokalemia. Clinical studies confirm its efficacy in rapidly normalizing potassium levels, making it a valuable therapeutic option for hyperkalemia management.