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Patiromer (Monograph)

Brand name: Veltassa
Drug 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

Medically reviewed by Drugs.com on Nov 2, 2023. Written by ASHP.

Introduction

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

Uses for Patiromer

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 inhibit 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

Patiromer Dosage and Administration

Administration

Oral Administration

Administer ≥3 hours before or ≥3 hours after other oral drugs.1 (See Interactions.)

Administer without regard to 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 40 mL of water.1 Stir, then add additional 40 mL of water. 1 Stir thoroughly; may add more water to achieve desired consistency.1 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 Patiromer

Contraindications

Warnings/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

Drug Interactions

Effects on GI Absorption of Drugs

Binds to approximately 50% of the oral drugs tested in vitro; clinical interaction studies indicate that concomitant oral administration with patiromer alters bioavailability of some of these drugs.1 10 (See Specific Drugs under Interactions.)

Binding could reduce GI absorption of oral drugs and result in loss of efficacy when administration times are close to those of patiromer.1 10 Administer other oral agents ≥3 hours before or ≥3 hours following administration of patiromer.1

Specific Drugs

Drug

Interaction

Comments

Allopurinol

No pharmacokinetic interaction in vitro1 10

Amlodipine

Pharmacokinetic interaction in vitro; no effect on systemic exposure of amlodipine in vivo1 10

Amoxicillin

No pharmacokinetic interaction in vitro1 10

Apixaban

No pharmacokinetic interaction in vitro1 10

Aspirin

No pharmacokinetic interaction in vitro1 10

Atorvastatin

No pharmacokinetic interaction in vitro1 10

Cephalexin

No pharmacokinetic interaction in vitro1 10

Cinacalcet

Pharmacokinetic interaction in vitro; no effect on systemic exposure of cinacalcet in vivo1 10

Ciprofloxacin

Concomitant oral administration resulted in decreased systemic exposure of ciprofloxacin; no interaction when administration times separated by 3 hours1 10

Separate administration times by ≥3 hours1

Clopidogrel

Pharmacokinetic interaction in vitro; no effect on systemic exposure of clopidogrel in vivo1 10

Digoxin

No pharmacokinetic interaction in vitro1 10

Furosemide

Pharmacokinetic interaction in vitro; no effect on systemic exposure of furosemide in vivo1 10

Glipizide

No pharmacokinetic interaction in vitro1 10

Levothyroxine

Concomitant oral administration resulted in decreased systemic exposure of levothyroxine; no interaction when administration times separated by 3 hours1 10

Separate administration times by ≥3 hours1

Lisinopril

No pharmacokinetic interaction in vitro1 10

Lithium

Pharmacokinetic interaction in vitro; no effect on systemic exposure of lithium in vivo1 10

Metformin

Concomitant oral administration resulted in decreased systemic exposure of metformin; no interaction when administration times separated by 3 hours1 10

Separate administration times by ≥3 hours1

Metoprolol

Pharmacokinetic interaction in vitro; no effect on systemic exposure of metoprolol in vivo1 10

Phenytoin

No pharmacokinetic interaction in vitro1 10

Riboflavin

No pharmacokinetic interaction in vitro1 10

Rivaroxaban

No pharmacokinetic interaction in vitro1 10

Spironolactone

No pharmacokinetic interaction in vitro1 10

Trimethoprim

Pharmacokinetic interaction in vitro; no effect on systemic exposure of trimethoprim in vivo1 10

Valsartan

No pharmacokinetic interaction in vitro1 10

Verapamil

Pharmacokinetic interaction in vitro; no effect on systemic exposure of verapamil in vivo1 10

Warfarin

Pharmacokinetic interaction in vitro; no effect on systemic exposure of warfarin in vivo1 10

Patiromer 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.)

Food

Mean dosage and effects on serum potassium concentration are similar whether patiromer is administered with or without food.1

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

Advice to Patients

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 2024, Selected Revisions November 12, 2018. 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; 2018 May.

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. http://www.ncbi.nlm.nih.gov/pubmed/25415805?dopt=AbstractPlus

4. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number205739Orig1s000: Summary review. From FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000SumR.pdf

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. http://www.ncbi.nlm.nih.gov/pubmed/26172895?dopt=AbstractPlus

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; http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4976659&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/26856345?dopt=AbstractPlus

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. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4678168&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/26376130?dopt=AbstractPlus

8. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number205739Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000ClinPharmR.pdf

10. Lesko LJ, Offman E, Brew CT et al. Evaluation of the potential for drug Interactions with patiromer in healthy volunteers. J Cardiovasc Pharmacol Ther. 2017; 22:434-446. http://www.ncbi.nlm.nih.gov/pubmed/28585859?dopt=AbstractPlus