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VELTASSA has a well-tolerated GI profile

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

CONSTIPATION

  • Generally resolved during the course of treatment
 7.2%

HYPOMAGNESEMIA

  • No patients experienced magnesium levels below 1.0 mg/dL
  • No patient discontinued VELTASSA because of hypomagnesemia
  • Consider magnesium supplementation in patients who develop low serum magnesium levels
 5.3%

DIARRHEA

 4.8%

NAUSEA

 2.3%

ABDOMINAL DISCOMFORT

 2.0%

FLATULENCE

 2.0%

In clinical trials, 2.7% of participants discontinued treatment due to GI reactions

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

 

 

Safety Profile for Pediatric Patients

In a single-arm, open-label pediatric study, 14 patients 12 to 17 years of age received at least one dose of VELTASSA, including 12 patients exposed for at least 25 weeks. The safety profile was generally similar to that observed in adult patients.

Drug interaction studies with VELTASSA

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INDICATION

VELTASSA is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older.

Limitation of Use: VELTASSA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

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INDICATION & Important Safety Information

Important Safety Information

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.

CONTRAINDICATIONS

VELTASSA is contraindicated in patients with a history of a hypersensitivity reaction to VELTASSA or any of its components.

INDICATION

VELTASSA is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older.

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 adult patients treated with VELTASSA. Approximately 9% of adult 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%) in adult patients treated with VELTASSA 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.The safety profile of VELTASSA in a study of 14 pediatric patients ages 12 to 17 years was generally similar to that observed in adult patients.