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

In 7 hours, VELTASSA reduced serum potassium in low-potassium-diet-resistant patients 0.21 milliequivalents per liter (mean).
  • Significant reduction of serum K+ at hour 7, with reductions starting at hour 4
  • K+ diet restricted to 60 mEq/day for three days prior to first dose
  • 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 a monotherapy for the emergency treatment of life-threatening hyperkalemia.

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

*P=0.004.

BID dosing studied, but not an approved dose.

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.

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.

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