Is Tenapanor approved for hyperphosphatemia?

Is Tenapanor approved for hyperphosphatemia?

Tenapanor is an oral, first-in-class inhibitor of the sodium-proton exchanger NHE3, and the application for approval for hyperphosphatemia in patients with CKD on dialysis was supported by three phase 3 clinical trials involving more than 1000 patients that all met their primary and key secondary endpoints, the company …

What causes severe hyperphosphatemia?

The most common cause of hyperphosphatemia is renal failure. Less common causes can be classified according to pathogenesis; ie, increased phosphate intake, decreased phosphate output, or a shift of phosphate from the intracellular to the extracellular space. Often, several mechanisms contribute.

Why does kidney cause high phosphate?

When your kidneys start to fail they cannot remove the excess phosphate from your body. Kidney disease also leads to an increase in production of parathyroid hormone. This also leads to too much phosphate in your body. The phosphate builds up in your body and binds to calcium.

What medications can cause hyperphosphatemia?

Several drugs, such as penicillin, corticosteroids, some diuretics, furosemide, and thiazides, can induce hyperphosphatemia as an adverse reaction.

Is tenapanor FDA approved?

(NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that the U.S. Food and Drug Administration has approved IBSRELA® (tenapanor), a 50 mg, twice daily oral pill for the treatment of …

What adverse effect is associated with tenapanor?

Aside from diarrhea, the other most common adverse effects linked with tenapanor treatment were abdominal distension, in 3%, and flatulence, also in 3%. Tenapanor is an inhibitor of sodium/hydrogen exchanger isoform 3, the predominant intestinal sodium transporter.

What is severe hyperphosphatemia?

Severe hyperphosphatemia, defined herein as levels of 14 mg/dL or higher, is almost invariably multifactorial–usually resulting from addition of phosphorus to the extracellular fluid together with decreased phosphorus excretion.

How does hyperphosphatemia affect the body?

Your body needs some phosphate to strengthen your bones and teeth, produce energy, and build cell membranes. Yet in larger-than-normal amounts, phosphate can cause bone and muscle problems and increase your risk for heart attacks and strokes. A high phosphate level is often a sign of kidney damage.

What causes high phosphorus in dialysis patients?

If your kidneys don’t function properly, you’re more likely to develop hyperphosphatemia. This leads to phosphorus building up in your blood. Your kidneys also turn vitamin D into a material to strengthen your bones. With CKD, your kidneys can’t use the vitamin D, making your bones weaker.

How does phosphate affect the kidneys?

Too much phosphorus may calcify the kidneys. “As more phosphate goes through the kidney, it accelerates micro-calcification of the kidney’s tubules,” Block explains. That can depress kidney function and also increase the risk of fatal heart attacks.

How is hyperphosphatemia treatment?

Administration of phosphate binders is the only truly long-term therapy for chronic hyperphosphatemia due to renal failure. Monitor calcium and phosphate levels, especially when treating patients with calcium-containing phosphate binders, because of the possibility of severe, life-threatening hypercalcemia.

When is tenapanor available?

On September 12, 2019 , Ardelyx received approval of IBSRELA (tenapanor) for the treatment of irritable bowel syndrome with constipation (IBS-C).

Does Tenapanor work for hyperphosphatemia?

Efficacy and Safety of Tenapanor in Patients with Hyperphosphatemia Receiving Maintenance Hemodialysis: A Randomized Phase 3 Trial Tenapanor significantly reduced elevated serum phosphate in patients with hyperphosphatemia receiving maintenance hemodialysis.

What is hyperphosphatemia and what causes it?

A plasma phosphate level higher than 4.5 mg/dL is hyperphosphatemia. Phosphate plays an essential role in many biological functions such as the formation of ATP, cyclic AMP, phosphorylation of proteins, etc. Phosphate is also present in nucleic acids and acts as an important intracellular buffer.

How does parathyroid hormone affect tubular reabsorption of phosphorus?

 Tubular reabsorption of phosphorus decreases by parathyroid hormone, phosphatonins, acidosis, hyperphosphatemia, chronic hypercalcemia, and volume expansion. Phosphorus is transported out of the renal cell by a phosphate-anion exchanger located in the basolateral membrane.