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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

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Vifor Pharma, Inc.
Corporate Headquarters

100 Cardinal Way
Redwood City, CA 94063

650-421-9500
info@viforpharma.com

VELTASSA patient support services

1-844-870-7597

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

U.S. Food and Drug Administration MedWatch

1-800-FDA-1088 (1-800-332-1088) www.FDA.gov/medwatch
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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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.