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Mean serum K+ results in a retrospective EHR analysis of more than 500 ESRD patients on dialysis1

Results of a real-world study of dialysis patients showed reductions in serum potassium after VELTASSA initiation.
  • Approximately 75% of patients had a baseline K+ of ≥5.5 mEq/L
  • 61% (n=322) started and remained on VELTASSA 8.4 g once daily
  • 75% of patients remained on VELTASSA for at least 80% of the study period
  • Safety was not evaluated in this retrospective analysis

Real-world data were retrospectively collected, are observational in nature, and are not based on controlled clinical studies.

Dialysis retrospective study design

Treatment of hyperkalemia in hemodialysis patients who newly initiated VELTASSA in real-world practice

In a retrospective observational study using Electronic Health Record (EHR) data (N=527), patients (≥18 years) receiving hemodialysis at a large U.S. dialysis provider between December 21, 2015, and December 20, 2016, were identified. K+ values were summarized in 6 sequential 30-day periods, 3 preceding and 3 following VELTASSA initiation. Patients had at least 24 hemodialysis treatments in the 3 months prior to VELTASSA initiation. Of 527 patients studied, the mean age was 59 years, 57% were men, 70% were white/Hispanic, and 17% were black.

VELTASSA acts where K+ is most abundant

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INDICATION

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.

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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.

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.

Hypomagnecemia: VELTASSA binds to magnesium in the colon, which can lead to hypomagnecemia. In clinical studies, hypomagnecemia was reported as an adverse reaction in 5.3% of patients treated with VELTASSA. Approximately 9% of patients in clinical trials developed hypomagnecemia 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%) were constipation (7.2%), hypomagnecemia (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 patients treated with VELTASSA and included edema of the lips.

ESRD=end-stage renal disease.

  1. Reference:
  2. 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