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Significant serum K+ reduction was observed within hours with VELTASSA in real-world settings1

A real-world analysis showed VELTASSA reduced serum potassium 0.5 milliequivalents per liter (mean) at 2.9 hours (mean).
  • Retrospective EHR data analysis of VELTASSA monotherapy for non–life-threatening hyperkalemia in 881 hospitalized patients
  • The lowest dose of VELTASSA, 8.4 g, was administered to 721 patients (81.8%); 82% of patients received just one dose
  • Mean (SD) times of obtaining a blood sample within each prespecified interval were: 2.9 (1.8) hours; 8.9 (1.7) hours; and 17.2 (3.1) hours

Baseline K+ level, mean (SD), mEq/L: 5.60 (0.35).

Study design

  • Retrospective cohort study: Electronic health records data from January 2018 through December 2019
  • Objective: Evaluate the outcomes associated with real-world VELTASSA use in 881 encounters of patients with non–life-threatening hyperkalemia in institutional settings
  • Study population: Patients aged 18 years or older who received at least 1 dose of patiromer (8.4 g, 16.8 g, or 25.2 g) for the treatment of an acute non–life-threatening hyperkalemia episode, defined as a serum potassium level greater than 5.0 mEq/L, in any institutional setting (emergency department, inpatient unit, or intensive care unit) were included
  • Primary endpoint: Mean absolute reduction in serum potassium level from baseline at 3 distinct time intervals after VELTASSA administration: 0 to 6 hours, greater than 6 to 12 hours, and greater than 12 to 24 hours
  • Limitations: This study did not have a control group; therefore, whether observed reductions in potassium levels were associated with VELTASSA alone could not be determined. The absence of a protocol for treatment and monitoring of hyperkalemia required exclusion of observations from the analysis in each time interval if a laboratory blood sample was not obtained. Real-world data were retrospectively collected, are observational in nature, and are not based on controlled clinical studies

This study was supported by Vifor Pharma, Inc., as an investigator-initiated study.

VELTASSA sustained K+ control over 52 weeks

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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.

SD=standard deviation.

  1. Reference:
  2. Di Palo KE, Sinnett MJ, Goriacko P. Assessment of patiromer monotherapy for hyperkalemia in an acute care setting. JAMA Netw Open. 2022;5(1):e2145236. doi:10.1001/jamanetworkopen.2021.45236