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Veltassa / patiromer Pharmacology Manufacturer Approval Date Indications Contraindications Black Box Warnings Warnings/Precautions Pregnancy/Lactation Pharmacokinetics Drug Interactions – Object Drugs Drug Interactions – Precipitant drugs Adverse Effects / Lab Abnormalities Monitoring Efficacy Monitoring Toxicity Dosing – Initial Dosing – Max Renal Adjustment Hepatic Adjustment A cation exchange polymer that increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract, resulting in a reduction of serum potassium levels. Relypsa Inc. 10/21/15 Indicated for the treatment of hyperkalemia. Not to be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. Hypersensitivity to patiromer sorbitex calcium or xanthan gum Patiromer binds to many orally administered medications, which could decrease their absorption and reduce their effectiveness. Administer other oral medications at least 6 hours before or 6 hours after patiromer. Choose patiromer or the other oral medication if adequate dosing separation is not possible. GI effects: Avoid use in patients with severe constipation, bowel obstruction or impaction as patiromer may worsen GI conditions. Hypomagnesemia: Patiromer binds to magnesium in the colon, which can lead to hypomagnesemia. Monitor serum magnesium and consider supplementation if hypomagnesemia develops. Patiromer is not absorbed systemically following oral administration Maternal use is not expected to result in fetal risk Breastfeeding is not expected to result in fetal risk Patiromer is not systemically absorbed and is excreted in the feces. There are no known significant interactions. Refer to black box warning. There are no known significant interactions. Refer to black box warning. Hypomagnesemia <1.4mg/dL (9%) Diarrhea (4.8%) Constipation (7.2%) Hypokalemia <3.5mEq/L (4.7%) Hypomagnesemia (5.3%) Nausea (2.3%) Decrease in serum potassium level, dose may be adjusted in 8.4 g increments in > 1 week intervals. Monitor serum potassium and serum magnesium levels 8.4 g by mouth daily. Administer with food. Mix the powder with water and make sure all of the powder is consumed. The powder should be refrigerated. Once the packet has been out of the refrigerator, it is good at room temperature up to 3 months. 25.2 g by mouth daily No dosage adjustment necessary. There are no dosage adjustments provided in the manufacturer’s labeling. Cost: Source: UpToDate.com – accessed 3/13/15 Dose(s) Brand – Generic 8.4 g powder for oral suspension Veltassa – patiromer 16.8 g powder for oral suspension 25.2 g powder for oral suspension $ (30 days) $1071 $714 $714 Summary Veltassa, patiromer, is a potassium binder indicated to treat hyperkalemia. It is not to be used as emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. Black box warning for patiromer binding to other oral medications. The administration of other oral medications should be given 6 hours before or 6 hours after the administration of patiromer. Patiromer has 3 different doses (8.4 g, 16.8 g, 25.2 g once daily) that can be adjusted at > 1 week intervals based on the patient’s serum potassium levels. Most common adverse drug effects include: constipation, hypomagnesemia, diarrhea, and nausea. Patiromer does not have any dosage adjustments for hepatic or renal impaired patients. References: 1. https://www.veltassa.com 2. Veltassa package insert. Relypsa Inc. Oct. 2015. 3. Bakris, GL 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 Jul 14;314(2):151-61. 4. Weir, MR et al. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015 Jan 15;372(3):211-21. Date Prepared: 03/23/2016 Editor: Peter G. Koval, Pharm.D., BCPS Author: Dylan Wagoner, Pharm.D. Candidate, UNC Eshelman School of Pharmacy