patiromer calcium 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
5056 1415477-49-4

Description:

MoleculeDescription

Synonyms:

  • patiromer calcium
  • patiromer sorbitex calcium
  • veltassa
  • RLY5016S
  • patiromer
  • RLY5016
  • patiromer glucitol calcium
binds potassium ions in the gastrointestinal tract to lower serum potassium levels
  • Molecular weight:
  • Formula: (C34H52CaO16(C2H3)n(C2H2F)m(C2H3)n(C2H3)p(C2H3)p)x
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
8.40 g O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Oct. 21, 2015 FDA RELYPSA INC
July 19, 2017 EMA VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 728.52 44.83 403 4935 456148 90166961
Hospitalisation 423.91 44.83 187 5151 127913 90495196
Blood potassium increased 277.46 44.83 85 5253 20664 90602445
Loss of employment 238.56 44.83 51 5287 2936 90620173
Constipation 235.71 44.83 166 5172 280229 90342880
Product dose omission issue 189.51 44.83 148 5190 291539 90331570
Hepatic steatosis 168.64 44.83 68 5270 36877 90586232
Product colour issue 157.67 44.83 29 5309 763 90622346
Cardiac failure congestive 152.12 44.83 86 5252 98608 90524501
Diarrhoea 123.68 44.83 207 5131 938983 89684126
Off label use 119.49 44.83 223 5115 1102029 89521080
Dialysis 108.36 44.83 36 5302 11293 90611816
Product taste abnormal 98.83 44.83 24 5314 2436 90620673
Abdominal pain upper 88.18 44.83 103 5235 332571 90290538
No adverse event 88.13 44.83 53 5285 67929 90555180
Abdominal discomfort 83.06 44.83 120 5218 477208 90145901
Cardiac failure 73.90 44.83 57 5281 109439 90513670
Inappropriate schedule of product administration 73.88 44.83 65 5273 149868 90473241
Malaise 72.47 44.83 126 5212 585860 90037249
Flatulence 63.49 44.83 36 5302 41331 90581778
Product solubility abnormal 62.83 44.83 14 5324 975 90622134
Gastric disorder 62.13 44.83 33 5305 33351 90589758
Nausea 55.95 44.83 167 5171 1110149 89512960
Product physical issue 46.29 44.83 16 5322 5644 90617465
Cough 45.00 44.83 79 5259 368883 90254226

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 1019.91 35.29 622 4007 470563 42146143
Hospitalisation 547.10 35.29 228 4401 74102 42542604
Constipation 412.44 35.29 241 4388 162050 42454656
Blood potassium increased 281.87 35.29 97 4532 18439 42598267
Product dose omission issue 271.78 35.29 182 4447 154183 42462523
Dialysis 194.87 35.29 66 4563 11920 42604786
Product taste abnormal 121.68 35.29 28 4601 1211 42615495
Product colour issue 93.48 35.29 20 4609 616 42616090
Flatulence 81.20 35.29 44 4585 25108 42591598
Diarrhoea 76.14 35.29 159 4470 460690 42156016
Inappropriate schedule of product administration 76.09 35.29 71 4558 95831 42520875
Off label use 69.41 35.29 187 4442 638148 41978558
Product solubility abnormal 61.17 35.29 14 4615 590 42616116
Abdominal discomfort 60.19 35.29 56 4573 75199 42541507
Product physical issue 57.42 35.29 19 4610 3180 42613526
No adverse event 56.43 35.29 41 4588 38980 42577726
Treatment noncompliance 44.32 35.29 35 4594 37637 42579069
Abdominal pain upper 41.64 35.29 48 4581 82561 42534145

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 1180.23 35.75 679 7089 698190 109883341
Hospitalisation 497.80 35.75 228 7540 142265 110439266
Constipation 397.70 35.75 269 7499 357517 110224014
Product dose omission issue 350.31 35.75 239 7529 321543 110259988
Blood potassium increased 348.05 35.75 118 7650 33131 110548400
Loss of employment 229.20 35.75 52 7716 3292 110578239
Off label use 157.76 35.75 332 7436 1499853 109081678
Diarrhoea 149.48 35.75 277 7491 1139228 109442303
Cardiac failure congestive 144.60 35.75 104 7664 150896 110430635
Hepatic steatosis 141.82 35.75 69 7699 48762 110532769
Abdominal discomfort 137.36 35.75 153 7615 393705 110187826
Dialysis 134.71 35.75 51 7717 19568 110561963
Abdominal pain upper 115.46 35.75 132 7636 348979 110232552
Product taste abnormal 113.66 35.75 28 7740 2524 110579007
Flatulence 111.63 35.75 60 7708 52089 110529442
Product colour issue 98.03 35.75 21 7747 1017 110580514
Inappropriate schedule of product administration 92.07 35.75 91 7677 203546 110377985
Product solubility abnormal 84.66 35.75 19 7749 1143 110580388
Gastric disorder 70.30 35.75 38 7730 33319 110548212
Malaise 69.02 35.75 148 7620 671671 109909860
Product physical issue 61.08 35.75 20 7748 5016 110576515
Cardiac failure 53.69 35.75 66 7702 187560 110393971
Blood potassium decreased 44.36 35.75 34 7734 54080 110527451
Therapeutic product effect decreased 42.96 35.75 68 7700 244248 110337283
Blood potassium abnormal 41.00 35.75 14 7754 3991 110577540
Treatment noncompliance 39.35 35.75 36 7732 72954 110508577
Left ventricular false tendon 38.20 35.75 6 7762 48 110581483
No adverse event 37.07 35.75 35 7733 73804 110507727
Cough 36.60 35.75 92 7676 461549 110119982
Renal transplant 35.83 35.75 12 7756 3226 110578305

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V03AE09 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Drugs for treatment of hyperkalemia and hyperphosphatemia
FDA MoA N0000178377 Potassium Ion Binding Activity
FDA EPC N0000178378 Potassium Binder
CHEBI has role CHEBI:35554 cardiovascular drug

Related Drugs by ATC class:

V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia 10 drugs
calcium acetatecalcium acetate and magnesium carbonatecalcium polystyrene sulfonatecolestilanferric citratelanthanum carbonatesevelamersodium polystyrene sulfonatesodium zirconium cyclosilicatesucroferric oxyhydroxide

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hyperkalemia indication 14140009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 16.8GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 8216560 March 14, 2027 TREATMENT OF HYPERKALEMIA
EQ 1GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 2, 2023 RX POWDER ORAL 8216560 March 14, 2027 TREATMENT OF HYPERKALEMIA
EQ 25.2GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 DISCN POWDER ORAL 8216560 March 14, 2027 TREATMENT OF HYPERKALEMIA
EQ 8.4GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 8216560 March 14, 2027 TREATMENT OF HYPERKALEMIA
EQ 16.8GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 8337824 May 29, 2030 TREATMENT OF HYPERKALEMIA
EQ 1GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 2, 2023 RX POWDER ORAL 8337824 May 29, 2030 TREATMENT OF HYPERKALEMIA
EQ 25.2GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 DISCN POWDER ORAL 8337824 May 29, 2030 TREATMENT OF HYPERKALEMIA
EQ 8.4GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 8337824 May 29, 2030 TREATMENT OF HYPERKALEMIA
EQ 16.8GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 11123363 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 16.8GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 9492476 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 16.8GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 9925212 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 1GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 2, 2023 RX POWDER ORAL 11123363 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 1GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 2, 2023 RX POWDER ORAL 9492476 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 1GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 2, 2023 RX POWDER ORAL 9925212 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 25.2GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 DISCN POWDER ORAL 11123363 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 25.2GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 DISCN POWDER ORAL 9492476 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 25.2GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 DISCN POWDER ORAL 9925212 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 8.4GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 11123363 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 8.4GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 9492476 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA
EQ 8.4GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL 9925212 Oct. 8, 2033 TREATMENT OF HYPERKALEMIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 16.8GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL Oct. 2, 2026 NEW PATIENT POPULATION
EQ 1GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 2, 2023 RX POWDER ORAL Oct. 2, 2026 NEW STRENGTH
EQ 25.2GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 DISCN POWDER ORAL Oct. 2, 2026 NEW PATIENT POPULATION
EQ 8.4GM BASE/PACKET VELTASSA VIFOR PHARMA N205739 Oct. 21, 2015 RX POWDER ORAL Oct. 2, 2026 NEW PATIENT POPULATION

Bioactivity Summary:

None

External reference:

IDSource
7T97I3787N UNII
D10149 KEGG_DRUG
1260643-52-4 SECONDARY_CAS_RN
4035186 VANDF
C4301626 UMLSCUI
CHEBI:752888 CHEBI
CHEMBL2107840 ChEMBL_ID
CHEMBL5315081 ChEMBL_ID
CHEMBL2107875 ChEMBL_ID
9532 INN_ID
C568789 MESH_SUPPLEMENTAL_RECORD_UI
DB09263 DRUGBANK_ID
1716203 RXNORM
236636 MMSL
31246 MMSL
d08388 MMSL
016559 NDDF
016560 NDDF
34716711000001109 SNOMEDCT_US
715260008 SNOMEDCT_US
763550001 SNOMEDCT_US
1208912-84-8 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VELTASSA HUMAN PRESCRIPTION DRUG LABEL 1 53436-010 POWDER, FOR SUSPENSION 1 g ORAL NDA 26 sections
VELTASSA HUMAN PRESCRIPTION DRUG LABEL 1 53436-084 POWDER, FOR SUSPENSION 8.40 g ORAL NDA 26 sections
VELTASSA HUMAN PRESCRIPTION DRUG LABEL 1 53436-168 POWDER, FOR SUSPENSION 16.80 g ORAL NDA 26 sections
VELTASSA HUMAN PRESCRIPTION DRUG LABEL 1 53436-252 POWDER, FOR SUSPENSION 25.20 g ORAL NDA 26 sections