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In HK adult patients resistant to a low-K+ diet, VELTASSA reduced serum K+ within hours1

IMPATIENT XL
  • Significant reduction of serum K+ at hour 7, with reductions starting at hour 4
  • K+ diet restricted to 60 mEq/day for patients who were on a potassium- and sodium-restricted diet during the inpatient phase of the study and were counseled to follow a low-potassium diet during the outpatient phase
  • 100% of participants were taking 1 or more RAAS inhibitors
  • Mean baseline eGFR was 34.8 mL/min per 1.73 m2

Due to its delayed onset of action, VELTASSA should not be used as monotherapy for the emergency treatment of life-threatening hyperkalemia.

 Baseline serum K+=5.5 to < 6.5 mEq/L.

*BID dosing studied, but not an approved dose.

P=0.004.

Study design

A phase 1, open-label, single-arm study in 27 patients with CKD and hyperkalemia taking RAAS inhibitors. The study enrolled patients who remained hyperkalemic after a 3-day, controlled diet run-in period. Two of 27 patients had K+ fall below 5.5 mEq/L after the low-K+ diet. The remaining 25 subjects with low-K+ diet–resistant hyperkalemia were dosed with VELTASSA 8.4 g BID for 34 hours. Serum K+ was assessed one hour before treatment: at baseline (hour 0); at 4, 7, and 10 hours post-dose; then every 2 to 4 hours until hour 48; at hour 58; and finally at outpatient follow-up on day 6.

VELTASSA reduced K+ within hours in a real-world study

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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.

BID=twice daily; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; RAAS=renin-angiotensin-aldosterone system.

  1. Reference: 
  2. Bushinsky DA, Williams GH, Pitt B, et al. Patiromer induces rapid and sustained potassium lowering in patients with chronic kidney disease and hyperkalemia. Kidney Int. 2015;88(6):1427–1433. doi:10.1038/ki.2015.270