VELTASSA® (patiromer) for oral suspension

Indication and Usage

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. Please see additional Important Safety Information Important Safety Information below and full Prescribing Information.

Powerful K+ reduction—sustained normokalemia1

Powerful K+ reduction—sustained normokalemia1

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

100% of patients had CKD, with the majority having type 2 diabetes mellitus

Baseline Demographics

Normokalemia was defined as serum K+ within the target range of 3.8 to <5.1 mEq/L.


*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.

OPAL-HK Study Part B3
VELTASSA (patiromer) Phase 1, 2-day study design VELTASSA (patiromer) Phase 1, 2-day study design

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 Week 4 to Week 8, 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.


OPAL-HK Study Design1
VELTASSA (patiromer) OPAL hyperkalemia study study design VELTASSA (patiromer) OPAL hyperkalemia study study design

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).

CKD=chronic kidney disease; RAAS=renin-angiotensin-aldosterone system.


*Baseline serum K+=5.1 to <5.5 mEq/L.
Baseline serum K+=5.5 to <6.5 mEq/L.
Target serum K+=3.8 to <5.1 mEq/L.


Please see Important Safety Information and full Prescribing Information.

Sustained normokalemia over 1 year2

VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 1 year. Up to 95% of patients who had moderate hyperkalemia had sustained serum K⁺ (potassium) target range VELTASSA (patiromer) efficacy - Mean serum K⁺ (potassium) at 1 year. Up to 95% of patients who had moderate hyperkalemia had sustained serum K⁺ (potassium) target range
  • Approximately 69% of all patients studied completed treatment at 52 weeks

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

Baseline Demographics

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


*Baseline serum K+=>5.0 to 5.5 mEq/L.
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.

AMETHYST-DN Study Design2,3
VELTASSA (patiromer) AMETHYST-DN 1 year study VELTASSA (patiromer) AMETHYST-DN 1 year study

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 receiving RAAS inhibitor therapy. 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.

CKD=chronic kidney disease; RAAS=renin-angiotensin-aldosterone system.


*Baseline serum K+=>5.0 to 5.5 mEq/L.
Baseline serum K+=>5.5 to <6.0 mEq/L.
Dose strength studied, but not commercially available.
§Target serum K+=3.8 to <5.0 mEq/L.


Please see Important Safety Information and full Prescribing Information.

Shift and remove K+ to treat
acute hyperkalemia4,5

Serum K+ may rise again if excess K+ is not removed from the body.

There are no restrictions in the VELTASSA PI regarding the concomitant use of VELTASSA with immediate-acting emergency treatments for hyperkalemia. VELTASSA should not be used alone as an emergency treatment for hyperkalemia because of its delayed onset of action.

In the inpatient setting, VELTASSA started reducing excess K+ at
4 hours and significantly reduced K+ at 7 hours

*Baseline serum K+=5.5 to <6.5 mEq/L.
P≤0.004.

PHASE 1, 2-Day Study Design5
VELTASSA (patiromer) Phase 1, 2-day study design VELTASSA (patiromer) Phase 1, 2-day study design

A phase 1, open‑label, single‑arm study in subjects with CKD and hyperkalemia who were receiving RAAS inhibitor therapy. The study comprised a 3‑day, controlled diet run‑in period, a 48‑hour treatment period during which subjects were dosed with VELTASSA 8.4 g BID for 34 hours, and an outpatient follow‑up period from Hour 58 to Day 6. Serum K+ was assessed at baseline (Hour 0), at 4, 7, and 10 hours post‑dose, then every 2 to 4 hours until Hour 48, and finally at follow‑up.

BID=twice daily; CKD=chronic kidney disease; CRU=clinical research unit; RAAS=renin-angiotensin-aldosterone system.

*Baseline serum K+=5.5 to <6.5 mEq/L.



Please see Important Safety Information and full Prescribing Information.
Important Safety Information, including Boxed WARNING

Indication and Usage

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.

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.

Adverse Reactions: The most common adverse reactions (incidence ≥2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3% of patients treated with VELTASSA and included edema of the lips.

Please see full Prescribing Information Prescribing Information The VELTASSA Prescribing Information has been updated to remove the Boxed WARNING for binding to other oral medications. Administer VELTASSA at least 3 hours before or 3 hours after other oral medications. Please see Section 12.3 for detailed drug interactions.
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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. 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. 3. Data on file as of July 2015. Relypsa, Inc. 4. Tamargo J, Caballero R, Delpón E. New therapeutic approaches for the treatment of hyperkalemia in patients treated with renin-angiotensin-aldosterone system inhibitors. Cardiovasc Drugs Ther. 2018. doi.org/10.1007/s10557-017-6767-5. 5. Bushinsky DA, Williams GH, Pitt B, et al. Patiromer induces rapid and sustained potassium lowering in patients with chronic kidney disease and hyperkalemia. Kidney Int. 2015:1-7.