Patiromer

Veltassa is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion. Veltassa increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract.

• 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 [see Clinical Pharmacology (12.2) ] .ICD-10: E87.5

• Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components [see Adverse Reactions (6.1) ]. Known hypersensitivity to Veltassa or any of its components.contraindicated

For adults, the recommended starting dose of Veltassa is 8.4 grams administered orally once daily. ( 2.2 ) For adults, adjust dose by 8.4 grams daily as needed at one-week intervals to obtain desired serum potassium target range. ( 2.2 ) For pediatric patients 12 to 17 years of age, the recommended starting dose of Veltassa is 4 grams administered orally once daily. ( 2.2 ) For pediatric patients 12 to 17 years of age, adjust dose by 4 grams daily as needed at one-week intervals to obtain desired serum potassium target range. ( 2.2 ) The maximum recommended dosage in adults and pediatric patients older than 12 years is 25.2 grams once daily. ( 2.2 ) 2.1 General Information Administer Veltassa at least 3 hours before or 3 hours after other oral medications except those shown to not have a clinically important interaction [see Drug Interactions (7) and Clinical Pharmacology (12.3) ]. Do not heat Veltassa (e.g., microwave) or add to heated foods or liquids. Do not take Veltassa in its dry form. 2.2 Recommended Dosing and Titration The recommended starting dose of Veltassa varies with age and is shown below. Multiple packets may be used to achieve the prescribed dose. 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 in adults and pediatric patients aged 12 years and older.

Worsening of Gastrointestinal Motility. ( 5.1 ) Hypomagnesemia. ( 5.2 ) 5.1 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 the clinical studies. 5.2 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 [see Adverse Reactions (6.1) ]. Monitor serum magnesium. Consider magnesium supplementation in patients who develop low serum magnesium levels on Veltassa.

The following adverse reaction is discussed in greater detail elsewhere in the label: Hypomagnesemia [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vifor Pharma, Inc. at 1-844-VELTASSA (1-844-835-8277) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Veltassa cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. In the safety and efficacy clinical trials, 666 adult patients received at least one dose of Veltassa, including 219 exposed for at least 6 months and 149 exposed for at least one year. Table 1 provides a summary of the most common adverse reactions (occurring in ≥ 2% of patients) in adult patients treated with Veltassa in these clinical trials. Most adverse reactions were mild to moderate. Constipation generally resolved during the course of treatment. Table 1: Adverse Reactions Reported in ≥ 2% of Patients Adverse Reactions Adult Patients treated with Veltassa (N=666) Note: Diarrhea is an aggregate term for Diarrhea and frequent bowel movements. Abdominal discomfort is an aggregate term for Abdominal discomfort, abdominal pain, abdominal pain upper, and abdominal pain lower.

8.1 Pregnancy Risk Summary Veltassa is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk. 8.2 Lactation Risk Summary Veltassa is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. 8.4 Pediatric Use The safety and effectiveness of Veltassa for lowering serum potassium levels have been established in pediatric patients ages 12 years and older. Use of Veltassa for this indication is supported by evidence from an adequate and well-controlled study in adults, with additional pharmacodynamic and safety data in pediatric patients aged 12 years and older [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , and Clinical Studies (14.3) ]. Safety and efficacy have not been established in pediatric patients below the age of 12 years. Although the pediatric study included 9 patients 6 to less than 12 years of age, the dosing regimen that was evaluated in these patients did not appear to be effective in reducing serum potassium levels in this age group after 2 weeks. The starting dose of Veltassa in this age group was 2 g/day and the median dose at Day 14 was 6 g/day. In this age group the mean change in serum potassium from Baseline to Day 14 was -0.1 mEq/L (95% CI -0.7, 0.4).

Metabolism

Absorption In radiolabeled ADME studies in rats and dogs, patiromer was not systemically absorbed and was excreted in the feces. Quantitative whole-body autoradiography analysis in rats demonstrated that radioactivity was limited to the gastrointestinal tract, with no detectable level of radioactivity in any other tissues or organs.

Doses of Veltassa in excess of 50.4 grams per day have not been tested. Excessive doses of Veltassa may result in hypokalemia. Restore serum potassium if hypokalemia occurs.

• Oct 21, 2015NDANDA205739Vifor Pharma

1. 1Constipation2,14116%
2. 2Death1,81113%
3. 3Diarrhoea1,2929.4%
4. 4Hospitalisation9707.1%
5. 5Off Label Use9276.8%
6. 6Blood Potassium Increased7955.8%
7. 7Nausea7095.2%
8. 8Drug Dose Omission6724.9%
9. 9Malaise5814.2%
10. 10Abdominal Discomfort5403.9%
11. 11Inappropriate Schedule Of Drug Administration4613.4%
12. 12Vomiting4463.3%
13. 13Abdominal Pain Upper4263.1%
14. 14No Adverse Event3772.7%
15. 15Dyspnoea3712.7%

The 10 most recently updated of 30 ClinicalTrials.gov registrations naming Patiromer as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
  Recruiting · Phase 2 · Interventional · 32 enrolled · Vifor Pharma, Inc.
  NCT05766839updated 2026-06-01
• Incremental Hemodialysis: The TwoPlus Trial
  Recruiting · Interventional · 350 enrolled · Wake Forest University Health Sciences
  NCT05828823updated 2026-05-22
• Comparison of Potassium Binders in the ER
  Terminated · Phase 4 · Interventional · 37 enrolled · University of California, Irvine
  NCT04585542updated 2026-04-22
• Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
  Completed · Phase 3 · Interventional · 262 enrolled · Vifor Fresenius Medical Care Renal Pharma
  NCT05136664updated 2026-04-13
• Potassium Correction for RAAS Optimization in Chronic Kidney Disease
  Recruiting · Phase 4 · Interventional · 44 enrolled · University Medical Center Groningen
  NCT06256991updated 2025-12-19
• Patiromer and Diet/hrQoL in Chronic Dialysis
  Recruiting · Phase 3 · Interventional · 40 enrolled · Mario Negri Institute for Pharmacological Research
  NCT06858280updated 2025-09-04
• Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
  Completed · Phase 4 · Interventional · 36 enrolled · Duke University
  NCT03781089updated 2025-05-30
• RELieving Increasing oEdema Due to Heart Failure
  Terminated · Phase 4 · Interventional · 19 enrolled · NHS Greater Glasgow and Clyde
  NCT04142788updated 2025-03-04
• Patiromer Trial in CKD Stage IIIB to V
  Terminated · Phase 3 · Interventional · 2 enrolled · Mario Negri Institute for Pharmacological Research
  NCT05786469updated 2024-11-12
• Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease
  Active not recruiting · Interventional · 13 enrolled · Nand Wadhwa
  NCT05050110updated 2024-08-02

Frequently asked questions

How does Patiromer work?

Veltassa is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion. Veltassa increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract.

What is Patiromer used for?

According to FDA labeling, Patiromer carries indications including: 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 [see Clinical Pharmacology (12.2) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Patiromer?

Patiromer is classified as Potassium Binder, Potassium Ion Binding Activity.

What are the brand names for Patiromer?

Patiromer is marketed under brand names including Veltassa.

What are the contraindications for Patiromer?

Patiromer labeling lists contraindications including: Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components [see Adverse Reactions (6.1) ]. Known hypersensitivity to Veltassa or any of its components.. Always consult the full prescribing information and a clinician.