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
  • Patient Portrayal

    When recurrent
    hyperkalemia
    threatens your
    treatment goals for
    patients with CKD,
    HF, or T2DM taking
    RAAS inhibitors

    KEEP THEM ON COURSE WITH VELTASSA2,3*

    LEARN MORE

    Recurring hyperkalemia doesn’t need to derail your patients again
    and again. Consider VELTASSA
    —the only once-daily, sodium-free
    K+ binder that helps you manage hyperkalemia for your patients.

    *In the OPAL-HK 12-week study, VELTASSA significantly lowered mean serum K+ by 1.01 mEq/L (P<0.001) to achieve and maintain normokalemia (3.8 to <5.1 mEq/L).2

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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K+=potassium; CKD=chronic kidney disease; HF=heart failure; T2DM=type 2 diabetes mellitus; RAAS=renin-angiotensin-aldosterone system.

References: 1. Data on file as of December 2019. Relypsa, Inc. 2. 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. 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. doi:10.1001/jama.2015.7446.

For Medical Information, drug safety adverse event reports, and/or product quality complaints:

1-844-RELYPSA (1-844-735-9772)

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.