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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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Hyperkalemia •••••••••••• ••••••• ••• •••••••••• - 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
Target Actions Organism APotassium binderHumans - 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.
Drug Interaction Integrate drug-drug
interactions in your softwareBisoprolol Patiromer can cause a decrease in the absorption of Bisoprolol resulting in a reduced serum concentration and potentially a decrease in efficacy. Carvedilol Patiromer can cause a decrease in the absorption of Carvedilol resulting in a reduced serum concentration and potentially a decrease in efficacy. Ciprofloxacin Patiromer can cause a decrease in the absorption of Ciprofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy. Levothyroxine Patiromer can cause a decrease in the absorption of Levothyroxine resulting in a reduced serum concentration and potentially a decrease in efficacy. Metformin Patiromer 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
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Product Ingredients
Ingredient UNII CAS InChI Key Patiromer sorbitex calcium 0LB9J2797D Not Available Not applicable - Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Veltassa Powder, for suspension 25.2 g/1 Oral Vifor Pharma, Inc. 2015-10-23 Not applicable US Veltassa Powder, for suspension 1.0 g Oral Vifor Fresenius Medical Care Renal Pharma France 2024-03-19 Not applicable EU Veltassa Powder, for suspension 25.2 g Oral Vifor Fresenius Medical Care Renal Pharma France 2020-12-16 Not applicable EU Veltassa Powder, for suspension 16.8 g Oral Vifor Fresenius Medical Care Renal Pharma France 2020-12-16 Not applicable EU Veltassa Powder, for suspension 8.4 g Oral Vifor Fresenius Medical Care Renal Pharma France 2020-12-16 Not applicable EU
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
- 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]
- 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]
- FDA Approved Drug Products: Veltassa (patiromer) for oral suspension (March 2023) [Link]
- Relypsa, Inc: Valtessa (patiromer) Safety Data Sheet (SDS) [Link]
- External Links
- KEGG Drug
- D10148
- PubChem Substance
- 347910426
- 1716203
- ChEMBL
- CHEMBL2107875
- Wikipedia
- Patiromer
- FDA label
- Download (352 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Prevention End Stage Renal Disease (ESRD) / Hyperkalemia 1 4 Completed Treatment Chronic Kidney Disease (CKD) / Hyperkalemia 1 4 Completed Treatment Hyperkalemia 1 4 Completed Treatment Hyperkalemia / Kidney Transplantation 2 4 Completed Treatment Renal Failure, Chronic Renal Failure 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Powder, for suspension Oral 1.0 g Powder, for suspension Oral 16.8 g / sachet Powder, for suspension Oral 16.8 G Powder, for suspension Oral 16.8 g/1 Powder, for suspension Oral 25.2 g / sachet Powder, for suspension Oral 25.2 G Powder, for suspension Oral 25.2 g/1 Powder, for suspension Oral 8.4 g/1 Powder, for suspension Oral 8.4 G Powder, for suspension Oral 8.4 g / sachet - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US8475780 No 2013-07-02 2024-03-30 US US8216560 No 2012-07-10 2027-03-14 US US8889115 No 2014-11-18 2024-03-30 US US8337824 No 2012-12-25 2030-05-29 US US7556799 No 2009-07-07 2025-02-27 US US8778324 No 2014-07-15 2024-03-30 US US8287847 No 2012-10-16 2024-03-30 US US8282913 No 2012-10-09 2026-03-11 US US8147873 No 2012-04-03 2026-03-11 US US9492476 No 2016-11-15 2033-10-08 US US9925212 No 2018-03-27 2033-10-08 US US10485821 No 2019-11-26 2024-03-30 US US11123363 No 2021-09-21 2033-10-08 US
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
References
- 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]
- 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]
- FDA Approved Drug Products: Veltassa (patiromer) for oral suspension (March 2023) [Link]
Drug created at October 27, 2015 15:43 / Updated at April 23, 2024 11:38