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Veltassa

Generic Name: Patiromer
Class: Potassium-removing Agents
Chemical Name: Hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes calcium
Molecular Formula: [[(C3H2FO2)2Ca]x[C8H14]z[C10H10]y,[C6H14O6]w]n
CAS Number: 1415477-49-4

Warning(s)

  • Binds many oral drugs; may decrease GI absorption and reduce efficacy of other agents.1 2 (See Effects on GI Absorption of Drugs under Interactions.)

Introduction

Nonabsorbed, cation-exchange polymer used for the removal of excess potassium.1 3 5 7

Uses for Veltassa

Hyperkalemia

Treatment of hyperkalemia.1 3 5

Efficacy in decreasing elevated serum potassium concentrations and reducing recurrence of hyperkalemia established in patients with chronic kidney disease receiving drugs that inhibits the renin-angiotensin-aldosterone system.1 3 Efficacy maintained during treatment for up to 1 year.1 5

Not used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.1

Veltassa Dosage and Administration

Administration

Oral Administration

Administer ≥6 hours before or ≥6 hours after other oral drugs.1 (See Effects on GI Absorption of Drugs under Interactions.)

Administer with food.1

Do not heat (e.g., in microwave) or add to heated foods or liquids.1

Administer as oral suspension; do not administer in dry form.1

Preparation of Oral Suspension

Empty entire contents of the packet(s) containing patiromer into glass or cup containing approximately 30 mL of water.1 Stir thoroughly, then add additional 60 mL of water. 1 Stir thoroughly again, then administer immediately.1

If powder remains in glass after initial administration, add more water, stir, and administer immediately; repeat, as needed, until the entire dose is administered.1

Dosage

Available as patiromer sorbitex calcium; dosage expressed in terms of patiromer.1

Adults

Hyperkalemia
Oral

Initially, 8.4 g once daily.1 Monitor serum potassium concentration; dosage may be increased (in 8.4-g increments at intervals of ≥1 week, up to 25.2 g daily) or reduced based on serum potassium concentration and desired target range.1

Prescribing Limits

Adults

Hyperkalemia
Oral

Maximum 25.2 g once daily.1

Special Populations

Hepatic Impairment

No special dosage recommendations.1

Renal Impairment

Dosage adjustments not necessary.1

Geriatric Patients

No special dosage recommendations.1

Cautions for Veltassa

Contraindications

  • Known hypersensitivity to patiromer or to any ingredient in the formulation.1

Warnings/Precautions

Warnings

Binding to Other Orally Administered Drugs

Binds many oral drugs; may decrease GI absorption and reduce efficacy of other agents.1 2 (See Effects on GI Absorption of Drugs under Interactions.)

Other Warnings and Precautions

Worsening of GI Motility Disorders

Clinical studies excluded patients with history of bowel obstruction or major GI surgery, severe GI disorders, or swallowing disorders.1

Avoid use in patients with severe constipation, bowel obstruction, or fecal impaction, including abnormal postoperative bowel motility disorders, because the drug may not be effective and may worsen GI conditions.1

Hypomagnesemia

Binds to magnesium in the colon, which can lead to hypomagnesemia.1 Monitor serum magnesium concentrations, and consider magnesium supplementation in patients with low serum magnesium concentrations.1

Specific Populations

Pregnancy

Not expected to cause fetal harm when administered to pregnant women because patiromer is not absorbed systemically following oral administration.1

Lactation

Breast-feeding not expected to result in risk to infants of patiromer-treated women because the drug is not absorbed systemically following oral administration.1

Pediatric Use

Safety and efficacy not established in pediatric patients.1

Geriatric Use

No overall differences in efficacy observed between geriatric patients and younger adults.1 However, adverse GI effects reported more frequently in those ≥65 years of age.1

Common Adverse Effects

Constipation,1 3 hypomagnesemia,1 3 diarrhea,1 3 nausea,1 3 abdominal discomfort,1 flatulence.1

Interactions for Veltassa

No formal drug interaction studies performed to date in humans.1

Effects on GI Absorption of Drugs

Binds to approximately 50% of the oral drugs tested in vitro.1 Binding could reduce GI absorption of the drugs and result in loss of efficacy when administration times are close to those of patiromer.1

Administer other oral agents ≥6 hours before or ≥6 hours following administration of patiromer.1 Monitor clinical response and/or blood concentrations of the drugs whenever possible.1 If adequate separation of dosing is not possible, select an alternative to either patiromer or the other oral agent.1

Veltassa Pharmacokinetics

Absorption

Bioavailability

Not absorbed systemically after oral administration.1 6

Onset

Onset of lowering of serum potassium observed in 7 hours.1 7 Maximum (steady-state) effects attained within 7–14 days with twice-daily dosing.8 (See Actions.)

Elimination

Elimination Route

Excreted in feces.1 6

Stability

Storage

Oral

Powder for Suspension

2–8°C; if stored at 25°C, use within 3 months.1 Do not expose to >40°C.1

Actions

  • Patiromer sorbitex calcium consists of patiromer, a nonabsorbed cation-exchange polymer, and a calcium-sorbitol counterion; used for the removal of excess potassium.1 3 5 7

  • Increases fecal potassium excretion via binding of potassium in the GI lumen, which decreases the free potassium concentration in the GI lumen and, consequently, reduces serum potassium concentrations.1

  • In patients with chronic kidney disease and hyperkalemia (mean serum potassium concentration of 5.9 mEq/L), patiromer (16.8 g daily in divided doses for 2 days) reduced serum potassium concentrations by 0.2 and 0.8 mEq/L at 7 and 48 hours, respectively; potassium concentrations stable for 24 hours after last dose, then began to increase.1 7

  • In healthy individuals, exhibits a dose-dependent increase in fecal potassium excretion and corresponding dose-dependent decrease in urinary potassium excretion, with no change in serum potassium concentrations.1 Effects on fecal and urinary potassium excretion similar whether administered as single daily dose or in 2 or 3 divided doses daily.1

Advice to Patients

  • Importance of reading the manufacturer's medication guide before beginning treatment and each time the prescription is refilled.1

  • Importance of administering other oral drugs ≥6 hours before or ≥6 hours after administration of patiromer.1

  • Importance of taking patiromer with food and of adhering to prescribed diet.1

  • Importance of preparing each dose immediately before administration according to instructions in the medication guide.1 Do not heat (e.g., in microwave) or add to heated foods or liquids; do not administer patiromer in its dry form.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Patiromer Sorbitex Calcium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

8.4 g (of patiromer) per packet

Veltassa

Relypsa

16.8 g (of patiromer) per packet

Veltassa

Relypsa

25.2 g (of patiromer) per packet

Veltassa

Relypsa

AHFS DI Essentials. © Copyright 2017, Selected Revisions January 20, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Relypsa, Inc. Veltassa (patiromer) powder for oral suspension prescribing information. Redwood City, CA; 2015 Oct.

2. Food and Drug Administration. FDA drug safety communication: FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate). Rockville, MD; 2015 Oct 22. From FDA website. Accessed 2016 Mar 3.

3. Weir MR, Bakris GL, Bushinsky DA et al. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015; 372:211-21. [PubMed 25415805]

4. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number205739Orig1s000: Summary review. From FDA website.

5. Bakris GL, Pitt B, Weir MR et al. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA. 2015; 314:151-61. [PubMed 26172895]

6. Li L, Harrison SD, Cope MJ et al. Mechanism of action and pharmacology of patiromer, a nonabsorbed cross-linked polymer that lowers serum potassium concentration in patients with hyperkalemia. J Cardiovasc Pharmacol Ther. 2016; [PubMed 26856345]

7. 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; 88:1427-1433. [PubMed 26376130]

8. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number205739Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website.

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