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.

Adverse reactions observed in clinical trials1,2


Please see below for additional Important Safety Information.

Most adverse reactions were mild to moderate across studies for up to 1 year.

Adverse reactions reported in ≥2% of patients treated with VELTASSA (N=666)*

Constipation
7.2%

Generally resolved during the course of treatment

Hypomagnesemia
5.3%

Monitor serum magnesium

  • Consider magnesium supplementation in patients who develop low serum magnesium levels on VELTASSA

  • No patient experienced magnesium levels below 1.0 mg/dL

  • No patient discontinued VELTASSA because of hypomagnesemia

Diarrhea
4.8%

Nausea
2.3%

Abdominal discomfort
2.0%

Flatulence
2.0%

*The dosage and duration of study treatment (4 to 52 weeks) and follow-up (1 to 4 weeks post-treatment) differed across the 4 studies pooled for this analysis.

 

Hypokalemia (serum K⁺ <3.5 mEq/L) in the pooled safety population

  • 4.7% of subjects experienced serum K⁺ <3.5 mEq/L
  • No subjects experienced serum K⁺ <3.0 mEq/L

Mild to moderate hypersensitivity reactions were reported in 0.3% of patients treated with VELTASSA in clinical trials

Reactions included edema of the lips.

2.7% discontinued due to GI reactions

Among the most common treatment-related adverse reactions reported across studies, 2.7% of patients discontinued due to GI reactions, including vomiting, diarrhea, constipation, and flatulence.

No trend in mean calcium values

No significant increase in baseline serum calcium was observed with longer treatment exposure.

GI=gastrointestinal.

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. Data on file. Relypsa, Inc. 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.