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 binds K+ throughout the GI tract, and may act longest in the colon where K+ is most abundant1

When K+ excretion is disrupted by CKD and/or RAAS inhibition, K+ may build up in the colon.

This causes the body to attempt to compensate with a marked increase in colonic secretion of K+

VELTASSA was designed to be fully ionized at the physiological pH of the colon for optimal ion exchange

Leveraging the body's natural compensatory mechanisms, VELTASSA binds K+ in exchange for calcium in the colon

VELTASSA is excreted with K+ to lower total body K+

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



VELTASSA removes excess K+ from the body

DOWNLOAD

VELTASSA was designed with novel physical and chemical properties1,2

SNAP

Sodium-free,
Non-Absorbed Polymer

Sodium-free

Exchanges K+ for Ca++

Sodium may cause issues for patients who cannot tolerate even a small increase in sodium load.

NON-ABSORBED

Non–metal-based powder

Based on radio-labeled drug-absorption studies, VELTASSA is not systemically absorbed.

Polymer

Spherical, Smooth, Uniform Microbeads

VELTASSA is an off-white to light brown powder for oral suspension with free-flowing properties.

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.
Continue
.

References: 1. Li L, Harrison SD, Cope MJ, et al. Mechanism of action and pharmacology of patiromer, a nonabsorbed cross-linked polymer that lowers serum potassium concentration in patients with hyperkalemia. J Cardiovasc Pharmacol Ther. 2016:1-10. doi:10.1177/1074248416629549. 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.