Boxed Warning Removed for Hyperkalemia Treatment

Veltassa was initially approved in October 2015 for the treatment of hyperkalemia.
Veltassa was initially approved in October 2015 for the treatment of hyperkalemia.

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) updating the label for Veltassa (patiromer; Relypsa) for oral suspension. 

Veltassa, a potassium binder, was approved in October 2015 for the treatment of hyperkalemia. With the sNDA approval, the product label no longer includes a Boxed Warning regarding the separation of Veltassa and other oral medications. This allows more flexibility for clinicians to prescribe Veltassa in combination with other oral agents. 

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Patients are now recommended to take Veltassa at least 3 hours before or 3 hours after other oral medications instead of at least 6 hours as previously indicated. The Dosage and Administration section as well as the Drug Interactions sections include additional information on this update; data from the drug-drug interaction program has been included in the Clinical Pharmacology section.

Veltassa is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion. It increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels. Veltassa is available as 8.4g, 16.8g, and 25.2g strength packets as powder for oral suspension.

For more information call (844) 735-9772 or visit Veltassa.com.

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