Real-World Inpatient Study

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

Retrospective EHR data analysis of VELTASSA monotherapy for non–life-threatening hyperkalemia in 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).

Serum K⁺ reduction was observed within hours, rapidly and regardless of HK severity¹

Retrospective assessment of VELTASSA monotherapy for non-life-threatening hyperkalemia in hospitalized patients
The association of VELTASSA with reduced serum potassium levels persisted across all baseline potassium ranges
In 2 instances (0.2%), patients experienced a hypokalemia episode (serum K⁺ level, < 3.5 mEq/L), and in 68 encounters (10.0%), patients developed hypomagnesemia (serum magnesium level, < 1.7 mg/dL) after VELTASSA administration
Both episodes of hypokalemia were mild and asymptomatic, with a serum potassium concentration between 3.2 and 3.4 mEq/L

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

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 > 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, > 6 to 12 hours, and > 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

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.

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.

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

Serum K+ reduction was observed within hours, rapidly and regardless of HK severity1

Study design

INDICATION

INDICATION & Important Safety Information

Important Safety Information

INDICATION

IMPORTANT SAFETY INFORMATION

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

Serum K⁺ reduction was observed within hours, rapidly and regardless of HK severity¹