FDA Approves Hyperkalemia Treatment

Veltassa binds with potassium in the gastrointestinal tract to reduce absorption.

Veltassa binds with potassium in the gastrointestinal tract to reduce absorption.

The FDA on Wednesday approved patiromer for oral suspension (Veltassa) for the treatment of hyperkalemia.

Hyperkalemia is a serious condition involving elevated potassium in the blood.

“Too much potassium in the blood can lead to dangerous, even fatal, changes in heart rhythm,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have treatment options for hyperkalemia available to patients.”

Potassium, which is necessary for cells to function properly, is removed from blood by the kidneys to keep its levels in the body properly balanced. Hyperkalemia typically afflicts individuals with acute or chronic kidney disease or heart failure.

The condition particularly affects patients taking drugs to inhibit the renin-angiotensin-aldosterone system that regulates blood pressure and balances fluid in the body.

Veltassa is a powdered medication patients take orally by mixing it with water. The drug binds with potassium in the gastrointestinal tract before leaving the body through the normal excretion process.

Veltassa showed efficacy in lowering potassium levels in hyperkalemic patients with chronic kidney disease who were on at least 1 drug to inhibit the renin-angiotensin-aldosterone system during clinical trials.

Adverse events common in patients taking Veltassa included constipation, decreased magnesium levels in the blood, diarrhea, nausea, abdominal discomfort, and flatulence.

The drug should not be used as an emergency therapy for life-threatening hyperkalemia due to delayed onset of action.

Veltassa also has a boxed warning due to binding with many other orally administered drugs. This may cause reduced absorption that diminishes the drug effects.

The boxed warning recommends taking Veltassa and other orally administered medications at least 6 hours apart.