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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

VELTASSA binds K+ throughout the GI tract and acts longest in the distal colon, where K+ is most abundant1-4

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

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

VELTASSA was designed with novel physical and chemical properties1,5

SNAP  

Sodium-free,
Non-Absorbed Polymer

Sodium-free

EXCHANGES K+ FOR Ca++

Sodium may cause issues for patients who cannot tolerate an 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

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. 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;21(5):456-465. doi:10.1177/1074248416629549. 2. Noureddine L, Dixon BS. Complications and management of hyperkalemia: implications for the use of the novel cation exchangers zirconium cyclosilicate and patiromer. Clin Invest (Lond). 2015;5(10):805-823. 3. Bronner F. Mechanisms of intestinal calcium absorption. J Cell Biochem. 2003;88(2):387-393. doi:10.1002/jcb.10330.
4. Sandle GI. Salt and water absorption in the human colon: a modern appraisal. Gut. 1998;43(2):294-299. doi:10.1136/gut.43.2.294.  5. 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.

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.