Patiromer

Identification

Summary

Patiromer is a non-absorbable potassium binding polymer indicated for the treatment of hyperkalemia.

Brand Names
Veltassa
Generic Name
Patiromer
DrugBank Accession Number
DB09263
Background

Patiromer is a powder for suspension in water for oral administration, approved in the U.S. as Veltassa in October, 2015. Patiromer is supplied as patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion. Each gram of patiromer is equivalent to a nominal amount of 2 grams of patiromer sorbitex calcium. The chemical name for patiromer sorbitex calcium is cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol. Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads.

Type
Small Molecule
Groups
Approved, Investigational
Synonyms
  • Patiromer
  • Patiromer FOS
External IDs
  • RLY5016

Pharmacology

Indication

Patiromer is indicated for the treatment of hyperkalemia.3

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofHyperkalemia••••••••••••••••••• ••• ••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

In clinical studies, patiromer decreased systemic exposure of some coadministered oral medications. The binding of patiromer to other oral medications may cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time patiromer is administered. Administer oral medications at least 3 hours before or 3 hours after patiromer.3

Mechanism of action

Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion. It increases fecal potassium excretion by binding to potassium in the lumen of the gastrointestinal tract, reducing the concentration of free potassium in the gastrointestinal lumen and, ultimately, in the serum.3

TargetActionsOrganism
APotassium
binder
Humans
Absorption

Patiromer is not systemically absorbed.3

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Patiromer is excreted entirely in the feces.3

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Patiromer is not absorbed and is unlikely to cause systemic toxicity. In animal toxicity studies, no adverse toxicological findings were noted with the exception of gastrointestinal adverse effects noted at in rats doses ≥3000 mg/kg.4

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
BisoprololPatiromer can cause a decrease in the absorption of Bisoprolol resulting in a reduced serum concentration and potentially a decrease in efficacy.
CarvedilolPatiromer can cause a decrease in the absorption of Carvedilol resulting in a reduced serum concentration and potentially a decrease in efficacy.
CiprofloxacinPatiromer can cause a decrease in the absorption of Ciprofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
LevothyroxinePatiromer can cause a decrease in the absorption of Levothyroxine resulting in a reduced serum concentration and potentially a decrease in efficacy.
MetforminPatiromer can cause a decrease in the absorption of Metformin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Food Interactions
  • Take with or without food. Mix into water or other soft foods or beverages prior to ingesting.

Products

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Product Ingredients
IngredientUNIICASInChI Key
Patiromer sorbitex calcium0LB9J2797DNot AvailableNot applicable
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
VeltassaPowder, for suspension8.4 gOralVifor Fresenius Medical Care Renal Pharma France2020-12-16Not applicableEU flag
VeltassaPowder, for suspension8.4 gOralVifor Fresenius Medical Care Renal Pharma France2022-06-13Not applicableEU flag
VeltassaPowder, for suspension25.2 gOralVifor Fresenius Medical Care Renal Pharma France2020-12-16Not applicableEU flag
VeltassaPowder, for suspension16.8 g / sachetOralVifor Fresenius Medical Care Renal Pharma Ltd2019-11-27Not applicableCanada flag
VeltassaPowder, for suspension16.8 gOralVifor Fresenius Medical Care Renal Pharma France2020-12-16Not applicableEU flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
1FQ2RY5YHH
CAS number
1260643-52-4
InChI Key
Not Available
InChI
Not Available
IUPAC Name
Not Available
SMILES
Not Available

References

General References
  1. Pitt B, Anker SD, Bushinsky DA, Kitzman DW, Zannad F, Huang IZ: Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J. 2011 Apr;32(7):820-8. doi: 10.1093/eurheartj/ehq502. Epub 2011 Jan 5. [Article]
  2. Montaperto AG, Gandhi MA, Gashlin LZ, Symoniak MR: Patiromer: a clinical review. Curr Med Res Opin. 2016;32(1):155-64. doi: 10.1185/03007995.2015.1106935. Epub 2015 Nov 19. [Article]
  3. FDA Approved Drug Products: Veltassa (patiromer) for oral suspension (March 2023) [Link]
  4. Relypsa, Inc: Valtessa (patiromer) Safety Data Sheet (SDS) [Link]
KEGG Drug
D10148
PubChem Substance
347910426
RxNav
1716203
ChEMBL
CHEMBL2107875
Wikipedia
Patiromer
FDA label
Download (352 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionEnd Stage Renal Disease (ESRD) / Hyperkalemia1
4CompletedTreatmentChronic Kidney Disease (CKD) / Hyperkalemia1
4CompletedTreatmentHyperkalemia1
4CompletedTreatmentHyperkalemia / Kidney Transplantation2
4CompletedTreatmentRenal Failure, Chronic Renal Failure1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Powder, for suspensionOral1.0 g
Powder, for suspensionOral16.8 G
Powder, for suspensionOral16.8 g/1
Powder, for suspensionOral16.8 g / sachet
Powder, for suspensionOral25.2 G
Powder, for suspensionOral25.2 g/1
Powder, for suspensionOral25.2 g / sachet
Powder, for suspensionOral8.4 g / sachet
Powder, for suspensionOral8.4 g/1
Powder, for suspensionOral8.4 G
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US8475780No2013-07-022024-03-30US flag
US8216560No2012-07-102027-03-14US flag
US8889115No2014-11-182024-03-30US flag
US8337824No2012-12-252030-05-29US flag
US7556799No2009-07-072025-02-27US flag
US8778324No2014-07-152024-03-30US flag
US8287847No2012-10-162024-03-30US flag
US8282913No2012-10-092026-03-11US flag
US8147873No2012-04-032026-03-11US flag
US9492476No2016-11-152033-10-08US flag
US9925212No2018-03-272033-10-08US flag
US10485821No2019-11-262024-03-30US flag
US11123363No2021-09-212033-10-08US flag

Properties

State
Solid
Experimental Properties
Not Available
Predicted Properties
Not Available
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available
Chromatographic Properties
Collision Cross Sections (CCS)
Not Available

Targets

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Kind
Small molecule
Organism
Humans
Pharmacological action
Yes
Actions
Binder
References
  1. van der Meer P, van Veldhuisen DJ: To bind or not to bind: potassium-lowering drugs in heart failure. Eur Heart J. 2011 Apr;32(7):791-2. doi: 10.1093/eurheartj/ehr058. Epub 2011 Mar 7. [Article]
  2. Pitt B, Anker SD, Bushinsky DA, Kitzman DW, Zannad F, Huang IZ: Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J. 2011 Apr;32(7):820-8. doi: 10.1093/eurheartj/ehq502. Epub 2011 Jan 5. [Article]
  3. FDA Approved Drug Products: Veltassa (patiromer) for oral suspension (March 2023) [Link]

Drug created at October 27, 2015 15:43 / Updated at June 02, 2024 21:56