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.
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OPAL-HK 12-Week Study

VELTASSA significantly lowered serum K+ and maintained normokalemia1

VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks

Normokalemia was defined as serum K+ within the target range of 3.8 to <5.1 mEq/L.   *A phase 3, 2-part, 12-week, multicenter study consisting of a 4-week, single-group, single-blind initial treatment phase and an 8-week, placebo-controlled, single-blind, randomized withdrawal phase in adult patients with CKD stage 3 or 4. Patients had serum K+ of 5.1 to <6.5 mEq/L and were receiving a stable dose of RAAS inhibitors. During the initial treatment phase, patients with mild hyperkalemia received an initial dose of VELTASSA 8.4 g/day (as a divided dose), and those with moderate to severe hyperkalemia received VELTASSA 16.8 g/day (as a divided dose). Part A primary endpoint: The mean change in patients with mild hyperkalemia from baseline (5.31 mEq/L) was
—0.65 mEq/L, and the change in those with moderate to severe hyperkalemia from baseline (5.74 mEq/L) was —1.23 mEq/L (P<0.001).   Baseline serum K+=5.1 to <5.5 mEq/L.
Baseline serum K+=5.5 to <6.5 mEq/L.   CKD=chronic kidney disease; RAAS=renin-angiotensin-aldosterone system.

100% of patients had CKD, with more than half having type 2 diabetes mellitus1

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VELTASSA maintained control of serum K+ and managed recurrence of hyperkalemia1

VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks

Part B was a single-blind, randomized, placebo-controlled, 8-week assessment of the withdrawal of VELTASSA conducted in patients with a Part A baseline serum K+ ≥5.5 mEq/L and who were normokalemic at the end of Part A. Part B was designed to determine whether chronic administration with VELTASSA maintained control of serum K+ and managed recurrence of hyperkalemia in patients with CKD taking RAAS inhibitors. Median serum K+ of the VELTASSA group remained stable from the start of the withdrawal phase to Week 4, while the placebo group had an increase in serum K+ by 0.72 mEq/L (primary endpoint; P<0.001). The randomized withdrawal approach was also chosen to help elucidate whether treatment with VELTASSA could be beneficial in the treatment of hyperkalemia as a consequence of poor renal function and RAAS-inhibitor medication usage.



>2x more patients did not experience a recurrence of hyperkalemia with VELTASSA vs placebo1

VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks

Normokalemia was defined as serum K+ within the target range of 3.8 to <5.1 mEq/L.   Part B was a single-blind, randomized, placebo-controlled, 8-week assessment of the withdrawal of VELTASSA conducted in patients with a Part A baseline serum K+ ≥5.5 mEq/L and who were normokalemic at the end of Part A. Part B was designed to determine whether chronic administration with VELTASSA maintained control of serum K+ and managed recurrence of hyperkalemia in patients with CKD taking RAAS inhibitors. Median serum K+ of the VELTASSA group remained stable from the start of the withdrawal phase to Week 4, while the placebo group had an increase in serum K+ by 0.72 mEq/L (primary endpoint; P<0.001). The randomized withdrawal approach was also chosen to help elucidate whether treatment with VELTASSA could be beneficial in the treatment of hyperkalemia as a consequence of poor renal function and RAAS-inhibitor medication usage.   * Moderate hyperkalemia was defined as serum K+ ≥5.5 mEq/L.   CKD=chronic kidney disease;
RAAS=renin-angiotensin-aldosterone system.

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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.

AMETHYST-DN 1-Year Study

Up to 95% of patients taking RAAS-inhibitor therapies maintained normokalemia over 1 year2,3

VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 4 weeks
  • 69% of all patients studied completed treatment at 52 weeks||

FDA has not approved VELTASSA for RAAS-inhibitor maintenance.

 

Normokalemia was defined as serum K+ within the target range of 3.8 to 5.0 mEq/L.

 

A phase 2, 52-week, multicenter, open-label, dose-ranging, randomized clinical trial in patients with CKD and type 2 diabetes mellitus. Patients had serum K+ >5.0 mEq/L and were on RAAS inhibitors. In patients with a baseline serum K+ of >5.0 to 5.5 mEq/L who received an initial dose of 8.4 g/day (as a divided dose), the mean daily dose was 14 g; in those with a baseline serum K+ of >5.5 to <6.0 mEq/L who received an initial dose of 16.8 g/day (as a divided dose), the mean daily dose was 20 g during the entire study.

  *Baseline serum K+=>5.0 to 5.5 mEq/L.
Dose strength studied, but not commercially available.
Baseline serum K+=>5.5 to <6.0 mEq/L.
§Significant (P<0.001) increases in least squares mean serum K+ levels were seen by Day 3 post-treatment.
||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.   RAAS=renin-angiotensin-aldosterone system;
CKD=chronic kidney disease;
ACE=angiotensin-converting enzyme;
ARB=angiotensin II receptor blocker.

100% of patients were receiving ACE inhibitors, ARBs, or other RAAS inhibitors2

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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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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. Data on file as of September 2014. Relypsa, 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.