Washington: The US Food and Drug Administration on Wednesday approved Veltassa (patiromer for oral suspension) to treat hyperkalaemia, a serious condition in which the amount of potassium in the blood is too high.
“Too much potassium in the blood can lead to dangerous, even fatal, changes in heart rhythm,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Centre for Drug Evaluation and Research. “It is important to have treatment options for hyperkalaemia available to patients.”
Potassium, a mineral that is delivered to the body by food, is needed for cells to function properly. The kidneys remove potassium from the blood to maintain a proper balance of potassium in the body. But when the kidneys are not able to remove enough potassium from the blood, the level of potassium can get too high.
Hyperkalaemia typically occurs in patients with acute or chronic kidney disease or heart failure, particularly in those who are taking drugs that inhibit the renin-angiotensin-aldosterone system, which regulates blood pressure and fluid balance in the body.
Veltassa, a powdered medication that patients mix with water and take by mouth, works by binding potassium in the gastrointestinal tract, decreasing its absorption. In clinical trials, Veltassa was effective in lowering potassium levels in hyperkalaemic participants with chronic kidney disease on at least one drug that inhibited the renin-angiotensin-aldosterone system.
In clinical trials, the most common adverse reactions reported by participants taking Veltassa were constipation, decreased magnesium levels in the blood (hypomagnesaemia), diarrhoea, nausea, abdominal discomfort, and flatulence. Veltassa should not be used as an emergency treatment for life-threatening hyperkalaemia because of its delayed onset of action, according to the FDA.
Veltassa has a boxed warning because it binds many other orally administered drugs, which could decrease their absorption and reduce their effects. The warning recommends taking it and any other orally administered medication at least six hours apart. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
Veltassa is manufactured by Relypsa Inc of Redwood City, California.
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