This website is intended for US healthcare audience only. If you are seeking global VELTASSA information, please click here.
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

Rates of discontinuation due to adverse reactions in VELTASSA clinical trials1-3

OPAL-HK 12-week study

4-week treatment phase

VELTASSA 6%
(All doses; N=237; n=15)

8-week randomized withdrawal phase

VELTASSA 2% (All doses; N=55; n=1)
Placebo 2% (N=52; n=1)

AMETHYST-DN 1-year study

VELTASSA 9.2%
(All doses; N=304*; n=28)

TOURMALINE 4-week study

VELTASSA 2.7%
(All doses; N=113; n=3)


2.7% discontinued due to GI reactions

  • Among the most common treatment-related adverse reactions reported across studies (N=666), 2.7% of patients discontinued due to GI reactions, including vomiting, diarrhea, constipation, and flatulence

*Based on the 306 patients randomized to a starting dose of VELTASSA. Of the randomized patients, 304 received VELTASSA and 301 had a serum K+ value at baseline for analysis.

GI=gastrointestinal.

Adverse reactions4-6

Adverse reactions reported in ≥2% of patients treated with VELTASSA across studies for up to 1 year (N=666)*

Constipation

Generally resolved during the course of treatment

7.2%

Hypomagnesemia

Monitor serum magnesium4

  • 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

5.3%
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

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

  • Reactions included edema of the lips

Sodium-free formulation

  • VELTASSA exchanges K+ for Ca++ instead of Na+
  • Non–metal-based spherical polymer
  • VELTASSA is administered with 1/3 cup of water for all doses

Mean calcium values with VELTASSA6

In the AMETHYST-DN 52-week study (N=304):
  • No change from baseline serum calcium was observed with longer treatment exposure
  • All patients treated with VELTASSA stayed in the normal range of serum calcium (8.5–10.3 mg/dL or
    2.12–2.57 mmol/L)

No obvious QT prolongation observed in VELTASSA clinical trials (N=666)5

  • Since VELTASSA is not absorbed, no QT studies were required to be conducted
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.

Please click here for full Prescribing Information.



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. Pergola PE, Spiegel DM, Warren S, et al. Patiromer lowers serum potassium when taken without food: comparison to dosing with food from an open-label, randomized, parallel group hyperkalemia study. Am J Nephrol. 2017;46(4):323-332. doi:10.1159/000481270. 4. Data on file as of October 2014. Vifor Pharma, Inc. 5. Data on file as of October 2015. Vifor Pharma, Inc. 6. Data on file as of September 2014. Vifor Pharma, Inc.

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.