Lokelma Approval History
Reviewed on May 20, 2018 by J.Stewart B.Pharm.
- FDA approved: Yes (First approved May 18th, 2018)
- Brand name: Lokelma
- Generic name: sodium zirconium cyclosilicate
- Dosage form: for Oral Suspension
- Company: AstraZeneca
- Treatment for: Hyperkalemia
Lokelma (sodium zirconium cyclosilicate) is a potassium binder indicated for the treatment of hyperkalemia in adults.
Lokelma should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Dosage and Administration
- 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.
- Adjust dose at one-week intervals as needed (by 5 g daily) to obtain desired serum potassium target range.
Warnings and Precautions
- Gastrointestinal Adverse Events in Patients with Motility Disorders: Avoid Lokelma in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders. Lokelma has not been studied in patients with these conditions and it may be ineffective and may worsen gastrointestinal conditions.
- Edema: Each 5 g dose of Lokelma contains approximately 400 mg of sodium. In clinical trials of Lokelma, edema was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily. Monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (eg, heart failure or renal disease). Advise patients to adjust dietary sodium, if appropriate. Increase the dose of diuretics as needed.
The most common adverse reaction with Lokelma was mild to moderate edema.
Lokelma can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least two hours before or two hours after Lokelma. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.
Development History and FDA Approval Process for Lokelma
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