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VELTASSA® (patiromer) for oral suspension
Important Safety Information 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. 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 patients treated with VELTASSA. Approximately 9% of 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%) 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 patients treated with VELTASSA and included edema of the lips.
Full Prescribing Information Patient Site Patient Support Services
Important Safety Information Full Prescribing Information Patient Site Patient Support Services

Consider VELTASSA for your hyperkalemia patients vulnerable to recurrence1-5

Hyperkalemia patients included in the OPAL-HK (12-week) and AMETHYST-DN (1-year) studies:

GUIDELINE - RECOMMENDED THERAPIES
CKD
CV Comorbidities

VELTASSA HAS OVER 4 YEARS OF REAL-WORLD USE

VELTASSA is the #1 prescribed, branded K+ binder—with over 100,000 patients prescribed

*American Heart Association guidelines published in 2017 have amended the definition of elevated blood pressure to an SBP of 120-129 mm Hg with a DBP of <80 mm Hg, from the previous standard of an SBP of 120-139 mm Hg or DBP of 80-89.


ACE=angiotensin-converting enzyme; ARB=angiotensin II receptor blocker; RAAS=renin-angiotensin-aldosterone system; CKD=chronic kidney disease; CV=cardiovascular; SBP=systolic blood pressure; DBP=diastolic blood pressure.

Important Safety Information, including Boxed WARNING

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.

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 patients treated with VELTASSA. Approximately 9% of 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%) 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 patients treated with VELTASSA and included edema of the lips.

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References: 1. Weir MR, Bakris GL, Bushinsky DA, et al; for OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015;372(3):211-221. doi:10.1056/NEJMoa1410853. 2. Bakris GL, Pitt B, Weir MR, et al; for AMETHYST-DN Investigators. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA. 2015;314(2):151-161. doi:10.1001/jama.2015.7446. 3. Data on file as of December 2019. Vifor Pharma, Inc. 4. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. J Am Coll Cardiol. 2018;71(19):e127-e248. doi:10.1016/j.jacc.2017.11.006. 5. Chobanian AV, Bakris GL, Black HR, et al; and National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure: JNC 7 report. Hypertension. 2003;42:1206-1252. doi:10.1161/01.HYP.0000107251.49515.c2.
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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.

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 patients treated with VELTASSA. Approximately 9% of 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%) 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 patients treated with VELTASSA and included edema of the lips.