Efficacy Study | VELTASSA® (patiromer)

VELTASSA maintained normokalemia through 1 year¹

VELTASSA helped patients with hyperkalemia maintain normokalemia for 52 weeks in the AMETHYST-DN study.

Up to 95% of patients with hyperkalemia maintained normokalemia
100% of patients were on RAAS inhibitors at baseline

Normokalemia was defined as serum K⁺ within the target range of 3.8 to 5.0 mEq/L.

^*Baseline serum K⁺>5.0 to 5.5 mEq/L.

^†Baseline serum K⁺>5.5 to <6.0 mEq/L.

^‡Dose strength studied, but not commercially available.

^§Significant (P<0.001) increases in least squares mean serum K⁺ levels were seen by day 3 post-treatment.

^*Significant (P<0.001) increases in least squares mean serum K⁺ levels were seen by day 3 post-treatment.

^†Baseline serum K⁺>5.0 to 5.5 mEq/L.

^‡Baseline serum K⁺>5.5 to <6.0 mEq/L.

^§Dose strength studied, but not commercially available.

Study design

A phase 2, 52-week, multicenter, open-label, dose-ranging, randomized clinical trial in patients with CKD and type 2 diabetes mellitus taking RAAS inhibitors, consisting of an 8-week initiation phase and a 44-week maintenance phase. The primary efficacy endpoint was the mean change in serum K⁺ level from baseline to week 4 or prior to the initiation of dose titration.

VELTASSA was studied in patients like yours who are vulnerable to hyperkalemia^1,2

In the OPAL-HK (12-week) and AMETHYST-DN (1-year) studies:

GUIDELINE- RECOMMENDED THERAPIES

100%of patients were receiving ACE inhibitors, ARBs, or other RAAS inhibitors

CKD

100% of patients had CKD, with the majority having type 2 diabetes mellitus

CV COMORBIDITIES

99% of patients had hypertension and up to 42% had heart failure

VELTASSA performance in a real-world dialysis study

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.

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.

Long-Term Study

VELTASSA maintained normokalemia through 1 year1

Study design

VELTASSA was studied in patients like yours who are vulnerable to hyperkalemia1,2

In the OPAL-HK (12-week) and AMETHYST-DN (1-year) studies:

GUIDELINE- RECOMMENDED THERAPIES

CKD

CV COMORBIDITIES

INDICATION

INDICATION & Important Safety Information

Important Safety Information

INDICATION

IMPORTANT SAFETY INFORMATION

VELTASSA maintained normokalemia through 1 year¹

VELTASSA was studied in patients like yours who are vulnerable to hyperkalemia^1,2