Posted from: Monday, June 04, 2018 - 11:14 AM - Present

Lokelma Approved to Treat Hyperkalemia

May 21, 2018 – The U.S. FDA has approved Lokelma (sodium zirconium cyclosilicate), manufactured by AstraZeneca, to treat hyperkalemia in adult patients.

Hyperkalemia occurs when an individual’s serum or plasma potassium level exceeds normal levels, and is frequently associated with cardiovascular, renal, and metabolic diseases. In clinical trials, Lokelma began lowering potassium levels an hour after administration. It restored potassium levels to normal 2.2 hours following administration. Maintenance dosing was shown to help keep potassium at normal levels for up to 12 months.

A highly-selective, oral potassium-removing agent, Lokelma should be taken three times daily at 10mg per dose for the first 48 hours. Physicians can adjust dosage at weekly intervals to achieve desired potassium levels. For maintenance, recommended dosing with Lokelma is 10mg once daily. The product will be available in packets of either 5mg or 10mg of powder for oral suspension. Patients should mix the powder with at least three tablespoons of water, and take any other medications at least two hours before or after taking Lokelma.

AstraZeneca has not yet announced launch or pricing plans.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, December 14, 2018 - 10:25 PM.