VELTASSA® (patiromer) for oral suspension

Indication and Usage

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. Please see additional Important Safety Information Important Safety Information below and full Prescribing Information.

VELTASSA was rigorously evaluated in patients with hyperkalemia1-4

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

CKD
GUIDELINE - RECOMMENDED THERAPIES
CV Comorbidities

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

*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.

A 2-PART, 12-WEEK, PHASE 3 STUDY1:
Baseline demographics of patients in the OPAL-HK Study
VELTASSA (patiromer) baseline demographics of patients in the OPAL-HK study VELTASSA (patiromer) baseline demographics of patients in the OPAL-HK study

AA=aldosterone antagonist;
ACE=angiotensin-converting enzyme;
ARB=angiotensin II receptor blocker;
GFR=glomerular filtration rate;
RAAS=renin-angiotensin-aldosterone system.

*Dual RAAS blockade refers to any combination of 2 or more of the following: ACE inhibitor, angiotensin II receptor blocker, aldosterone antagonist, or renin inhibitor.

The maximal dose was determined according to the judgment of the investigator in accordance with the local standard of care.

 



A PHASE 2, 52-WEEK, DOSE-RANGING STUDY3:
Baseline demographics of patients in the AMETHYST-DN Study
VELTASSA (patiromer) baseline demographics of patients in the AMYTHEST-DN study VELTASSA (patiromer) baseline demographics of patients in the AMYTHEST-DN study

AA=aldosterone antagonist;
ACE=angiotensin-converting enzyme;
ARB=angiotensin II receptor blocker;
CKD=chronic kidney disease;
GFR=glomerular filtration rate;
RAAS=renin-angiotensin-aldosterone system.

*Baseline serum K+=>5.0 to 5.5 mEq/L.

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

Calculated as weight in kilograms divided by height in meters squared.

 



A 4-WEEK, PHASE 4 STUDY5:
Baseline demographics of patients in the TOURMALINE study
VELTASSA (patiromer) baseline demographics of patients in the TOURMALINE study VELTASSA (patiromer) baseline demographics of patients in the TOURMALINE study

CKD=chronic kidney disease;
RAAS=renin-angiotensin-aldosterone system inhibitor.

*Baseline serum K+ is defined as the mean of serum K+ from the central laboratory on 2 consecutive days (Day -1 and Day 1) immediately prior to the first dose of VELTASSA.

All non–RAAS inhibitor diuretics were K+ wasting.

 



Please see Important Safety Information and full Prescribing Information Prescribing Information Please see the revised Section 2.3 of the VELTASSA Prescribing Information. The preparation instructions have been revised to include water measurement in cups (instead of ounces).
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Important Safety Information, including Boxed WARNING

Indication and Usage

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.

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.

Adverse Reactions: The most common adverse reactions (incidence ≥2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3% of patients treated with VELTASSA and included edema of the lips.

Please see full Prescribing Information Prescribing Information The VELTASSA Prescribing Information has been updated to remove the Boxed WARNING for binding to other oral medications. Administer VELTASSA at least 3 hours before or 3 hours after other oral medications. Please see Section 12.3 for detailed drug interactions.
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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. 2. 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. Hypertension. 2017. doi:10.1161/HYP.0000000000000065. 3. 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. 4. National Institutes of Health, U.S. Department of Health and Human Services. The seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Bethesda, MD: National Institutes of Health; 2004. NIH publication 04-5230. 5. Data on file. Relypsa, Inc.