Veltassa (patiromer)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2015

Specific Treatments:

hyperkalemia

Therapeutic Areas

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General Information

Veltassa (patiromer) is a potassium binder. 

Veltassa is specifically indicated for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Veltassa is supplied as a suspension for oral administration. The recommended starting dose of Veltassa is 8.4 grams patiromer once daily. Monitor serum potassium and adjust the dose of Veltassa based on the serum potassium level and the desired target range. The dose may be increased or decreased, as necessary, to reach the desired serum potassium concentration, up to a maximum dose of 25.2 grams once daily. The dose can be up-titrated based on serum potassium level at 1-week or longer intervals, in increments of 8.4 grams. 

Veltassa binds to many orally administered medications, which could decrease their absorption and reduce their effectiveness. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Choose Veltassa or the other oral medication if adequate dosing separation is not possible.

Clinical Results

FDA Approval

The FDA approval of Veltassa was based on a two-part, single-blind randomized withdrawal study that evaluated Veltassa in hyperkalemic patients with CKD on stable doses of at least one renin-angiotensin-aldosterone system inhibitor. In Part A, 243 patients were treated with Veltassa for 4 weeks. Patients with a baseline serum potassium of 5.1 mEq/L to < 5.5 mEq/L received a starting Veltassa dose of 8.4 grams patiromer per day (as a divided dose) and patients with a baseline serum potassium of 5.5 mEq/L to < 6.5 mEq/L received a starting Veltassa dose of 16.8 grams patiromer per day (as a divided dose). The dose of Veltassa was titrated, as needed, based on the serum potassium level, assessed starting on Day 3 and then at weekly visits (Weeks 1, 2 and 3) to the end of the 4-week treatment period, with the aim of maintaining serum potassium in the target range (3.8 mEq/L to < 5.1 mEq/L). The Part A primary endpoint, the change in serum potassium from Baseline to Week 4, was with statistical significance. For the Part A secondary endpoint, 76% of patients had a serum potassium in the target range of 3.8 mEq/L to < 5.1 mEq/L at Week 4. In Part B, 107 patients with a Part A baseline serum potassium of 5.5 mEq/L to < 6.5 mEq/L and whose serum potassium was in the target range (3.8 mEq/L to < 5.1 mEq/L) at Part A Week 4 and still receiving RAAS inhibitor medication were randomized to continue Veltassa or to receive placebo to evaluate the effect of withdrawing Veltassa on serum potassium. In patients randomized to Veltassa, the mean daily dose was 21 grams at the start of Part B and during Part B. The Part B primary endpoint was the change in serum potassium from Part B baseline to the earliest visit at which the patient’s serum potassium was first outside of the range of 3.8 to < 5.5 mEq/L, or to Part B Week 4 if the patient’s serum potassium remained in the range. In Part B, serum potassium rose by 0.72 mEq/L in patients who were switched to placebo, versus no change in patients who remained on Veltassa. 

Side Effects

Adverse effects associated with the use of Veltassa may include, but are not limited to, the following:

  • constipation
  • hypomagnesemia
  • diarrhea
  • nausea
  • abdominal discomfort
  • flatulence

 

Mechanism of Action

Veltassa (patiromer) is a potassium binder. Veltassa increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.

Additional Information

For additional information regarding Veltassa or hyperkalemia, please visit https://www.veltassa.com