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VELTASSA maintained normokalemia through 1 year1

AMETHYST CHART XL
  • Up to 95% of patients with hyperkalemia maintained normokalemia
  • 100% of patients were on RAAS inhibitors at baseline

Normokalemia was defined as serum K+ within the target range of 3.8 to 5.0 mEq/L.

*Baseline serum K+ = > 5.0 to 5.5 mEq/L.

†Baseline serum K+ = > 5.5 to < 6.0 mEq/L.

‡Dose studied, but not commercially available.

§Significant (P<0.001) increases in least squares mean serum K+ levels were seen by day 3 post-treatment.

 

Study design

A phase 2, 52-week, multicenter, open-label, dose-ranging, randomized clinical trial in patients with CKD and type 2 diabetes mellitus taking RAAS inhibitors, consisting of an 8-week initiation phase and a 44-week maintenance phase. The primary efficacy endpoint was the mean change in serum K+ level from baseline to week 4 or prior to the initiation of dose titration.

VELTASSA was studied in patients like yours who are vulnerable to hyperkalemia1-5

Overview page about results in clinical, prospective studies

VELTASSA data on dialysis

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INDICATION

VELTASSA is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older.

Limitation of Use: VELTASSA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

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INDICATION & Important Safety Information

Important Safety Information

VELTASSA is indicated for the treatment of hyperkalemia.

Limitation of Use: VELTASSA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

CONTRAINDICATIONS

VELTASSA is contraindicated in patients with a history of a hypersensitivity reaction to VELTASSA or any of its components.

INDICATION

VELTASSA is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older.

Limitation of Use: VELTASSA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VELTASSA is contraindicated in patients with a history of a hypersensitivity reaction to VELTASSA or any of its components.

WARNINGS AND PRECAUTIONS

Worsening of Gastrointestinal Motility: Avoid use of VELTASSA in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because VELTASSA may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia: VELTASSA binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3% of adult patients treated with VELTASSA. Approximately 9% of adult patients in clinical trials developed hypomagnesemia with a serum magnesium value < 1.4 mg/dL. Monitor serum magnesium. Consider magnesium supplementation in patients who develop low serum magnesium levels.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions (incidence ≥  2%) in adult patients treated with VELTASSA were constipation (7.2%), hypomagnesemia (5.3%), diarrhea (4.8%), nausea (2.3%), abdominal discomfort (2.0%) and flatulence (2.0%). Mild to moderate hypersensitivity reactions were reported in 0.3% of adult patients treated with VELTASSA and included edema of the lips.The safety profile of VELTASSA in a study of 14 pediatric patients ages 12 to 17 years was generally similar to that observed in adult patients.

ACE=angiotensin-converting enzyme; ARB=angiotensin II receptor blocker; CKD=chronic kidney disease; CV=cardiovascular; RAAS=renin-angiotensin-aldosterone system.

  1. References: 
  2. Bakris GL, Pitt B, Weir MR, et al; for AMETHYST-DN Investigators. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA. 2015;314(2):151–161. doi:10.1001/jama.2015.7446 
  3. Weir MR, Bakris GL, Bushinsky DA, et al; for OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015;372(3):211–221. doi:10.1056/NEJMoa1410853 
  4. Pinnell D, Patel S, Qualls J, et al. Real-world evaluation of patiromer utilization and its effects on serum potassium in veterans with end stage kidney disease. Medicine (Baltimore). 2022;101(50):e32367. doi:10.1097/MD.0000000000032367 
  5. Kovesdy CP, Rowan CG, Conrad A, et al. Real-world evaluation of patiromer for the treatment of hyperkalemia in hemodialysis patients. Kidney Int. 2018;4(2):301–309. doi:10.1016/j.ekir.2018.10.020 
  6. Amdur RL, Paul R, Barrows ED, et al. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020;98(5):1331–1340. doi:10.1016/j.kint.2020.06.042