|The full article is available to subscribers||Subscriber Login|
The FDA has approved patiromer (Veltassa – Relypsa), an oral potassium binder, for treatment of hyperkalemia. It is the first drug to be approved for this indication since the cation-exchange resin sodium polystyrene sulfonate (Kayexalate, and others) in 1958. Patiromer is not indicated for emergency correction of life-threatening hyperkalemia. Sodium zirconium cyclosilicate, another oral potassium binder, is currently being reviewed by the FDA; a decision on its approval is expected in May 2016.
HYPERKALEMIA — Hyperkalemia (serum potassium level >5.0 mEq/L) can occur in patients with renal disease or in those taking drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), direct renin inhibitors, and aldosterone antagonists. Dosage reduction or discontinuation of RAAS inhibitors because... more
- FDA. Kayexalate (sodium polystyrene sulfonate) powder. Detailed view: safety labeling changes approved by FDA Center for Drug Evaluation and Research (CDER). January 2011. Available at: www.fda.gov. Accessed February 4, 2016.
- Z Harel et al. Gastrointestinal adverse events with sodium polystyrene sulfonate (Kayexalate) use: a systematic review. Am J Med 2013; 126:264.
- M Watson et al. Damned if you do, damned if you don't: potassium binding resins in hyperkalemia. Clin J Am Soc Nephrol 2010; 5:1723.
- FDA Drug Safety Communication: FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate). October 22, 2015. Available at: www. fda.gov. Accessed February 4, 2016.
- GL Bakris et al. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA 2015; 314:151.
- MR Weir et al. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med 2015; 372:211.
- DA Bushinsky et al. Patiromer induces rapid and sustained potassium lowering in patients with chronic kidney disease and hyperkalemia. Kidney Int 2015; 88:1427.
- Approximate wholesale acquisition cost (WAC). WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. January 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.