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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.

Adverse Reactions

The most common adverse reaction with Lokelma was mild to moderate edema.

Drug Interactions

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

DateArticle
May 18, 2018Approval FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia
Mar 17, 2017AstraZeneca Receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for Hyperkalemia
Oct 18, 2016FDA Accepts for Review New Drug Application for Sodium Zirconium Cyclosilicate (ZS-9) for the Treatment of Hyperkalemia
May 27, 2016AstraZeneca Receives Complete Response Letter from FDA for Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia
Jul 29, 2015ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application
May 26, 2015ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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