Hyperkalemia Treatment Granted FDA Approval

The FDA has approved Relypsa’s patiromer (Veltassa) for the treatment of hyperkalemia, a serious condition in which there is an elevated level of potassium in a patient’s blood.

The drug, an oral suspension, reduces the absorption of potassium by binding to it in a patient’s gastrointestinal tract. Based on data from clinical trials, the FDA deemed Veltassa to be effective at lowering potassium levels in hyperkalemic participants with chronic kidney disease who were also taking at least 1 drug that inhibited the renin-angiotensin-aldosterone system.

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

Veltassa was approved with a boxed warning cautioning patients and providers that the drug binds many other orally administered drugs, potentially decreasing their absorption and reducing their effects. The warning recommends that patients take it and any other orally administered medication at least 6 hours apart.

Because of the drug's delayed oset of action, it should not be used as an emergency treatment for life-threatening hyperkalemia. The most common adverse reactions reported by trial participants treated with Veltassa include constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.