radium Ra 223 dichloride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4800 444811-40-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • Ra 223 dichloride
  • radium chloride RA-223
  • radium Ra 223 dichloride
  • xofigo
  • alpharadin
  • BAY 88-8223
  • radium (223Ra) dichloride
  • radium RA-223 dichloride
  • Radium-223 dichloride
  • Molecular weight: 293.92
  • Formula: Cl2Ra
  • CLOGP: -1.32
  • LIPINSKI: None
  • HAC: 0
  • HDO: 0
  • TPSA:
  • ALOGS: -0.60
  • ROTB: 0

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
May 15, 2013 FDA BAYER HLTHCARE

FDA Adverse Event Reporting System (Female)

None

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
Prostatic specific antigen increased 1035.82 29.90 282 6119 12282 29555844
Metastases to bone 586.74 29.90 172 6229 9726 29558400
Metastases to liver 348.93 29.90 121 6280 11735 29556391
Bone pain 239.79 29.90 104 6297 18348 29549778
Prostate cancer metastatic 219.61 29.90 69 6332 4897 29563229
General physical health deterioration 193.44 29.90 167 6234 102690 29465436
Prostate cancer 184.26 29.90 96 6305 25431 29542695
Prostate cancer stage IV 174.72 29.90 38 6363 617 29567509
Anaemia 174.41 29.90 215 6186 200736 29367390
Metastases to lymph nodes 170.05 29.90 54 6347 3963 29564163
Spinal cord compression 159.29 29.90 50 6351 3532 29564594
Haemoglobin decreased 134.64 29.90 140 6261 108235 29459891
Osteonecrosis of jaw 133.28 29.90 67 6334 16443 29551683
Disease progression 122.28 29.90 117 6284 81799 29486327
Metastasis 108.48 29.90 37 6364 3392 29564734
Metastases to spine 99.34 29.90 31 6370 2145 29565981
Platelet count decreased 98.45 29.90 117 6284 104555 29463571
Pathological fracture 92.97 29.90 34 6367 3821 29564305
Laboratory test abnormal 88.93 29.90 53 6348 18132 29549994
Death 87.65 29.90 213 6188 341871 29226255
Metastases to lung 84.99 29.90 39 6362 7816 29560310
Bone marrow failure 80.31 29.90 58 6343 27391 29540735
Pancytopenia 73.26 29.90 90 6311 83078 29485048
Metastases to soft tissue 70.05 29.90 15 6386 225 29567901
Blood test abnormal 69.99 29.90 31 6370 5718 29562408
Pain 67.01 29.90 127 6274 171305 29396821
Full blood count abnormal 66.30 29.90 41 6360 14972 29553154
Thrombocytopenia 64.33 29.90 109 6292 134714 29433412
Hospitalisation 63.42 29.90 63 6338 45925 29522201
Hormone-refractory prostate cancer 55.69 29.90 15 6386 614 29567512
Metastases to central nervous system 54.75 29.90 28 6373 7103 29561023
Metastases to bone marrow 54.71 29.90 14 6387 468 29567658
Prostate cancer recurrent 50.13 29.90 15 6386 900 29567226
Blood alkaline phosphatase increased 44.95 29.90 42 6359 28364 29539762
Decreased appetite 44.03 29.90 97 6304 145245 29422881
Bone marrow infiltration 43.37 29.90 9 6392 115 29568011
Traumatic fracture 41.71 29.90 10 6391 254 29567872
Blood alkaline phosphatase decreased 41.51 29.90 12 6389 638 29567488
Malignant neoplasm progression 40.95 29.90 64 6337 73795 29494331
Malaise 40.11 29.90 99 6302 159503 29408623
Cancer pain 39.73 29.90 16 6385 2331 29565795
Femur fracture 38.44 29.90 22 6379 6969 29561157
Asthenia 33.17 29.90 112 6289 215138 29352988
Pelvic pain 31.19 29.90 13 6388 2066 29566060
Spinal compression fracture 30.38 29.90 18 6383 6076 29562050

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
Prostatic specific antigen increased 863.23 34.58 183 4355 8577 64485617
Metastases to bone 348.17 34.58 105 4433 20330 64473864
Metastases to liver 215.80 34.58 76 4462 23865 64470329
Anaemia 200.98 34.58 184 4354 378496 64115698
Prostate cancer metastatic 181.90 34.58 43 4495 3261 64490933
Bone pain 155.90 34.58 73 4465 47499 64446695
Prostate cancer 148.89 34.58 55 4483 19740 64474454
Platelet count decreased 117.83 34.58 96 4442 167615 64326579
Metastases to lymph nodes 115.45 34.58 37 4501 8680 64485514
General physical health deterioration 113.05 34.58 102 4436 204323 64289871
Prostate cancer stage IV 108.97 34.58 21 4517 594 64493600
Osteonecrosis of jaw 108.86 34.58 54 4484 39771 64454423
Haemoglobin decreased 105.22 34.58 96 4442 194967 64299227
Death 99.34 34.58 144 4394 482561 64011633
Metastases to spine 85.26 34.58 24 4514 3619 64490575
Laboratory test abnormal 82.06 34.58 38 4500 24025 64470169
Hospitalisation 81.70 34.58 56 4482 75151 64419043
Metastases to soft tissue 79.53 34.58 15 4523 377 64493817
Pathological fracture 78.80 34.58 28 4510 8977 64485217
Spinal cord compression 74.65 34.58 24 4514 5679 64488515
Thrombocytopenia 74.59 34.58 85 4453 223716 64270478
Pancytopenia 74.17 34.58 69 4469 143240 64350954
Metastases to lung 67.74 34.58 29 4509 15235 64478959
Metastasis 66.58 34.58 22 4516 5673 64488521
Blood test abnormal 65.50 34.58 27 4511 12916 64481278
Bone marrow failure 62.44 34.58 40 4498 47912 64446282
Decreased appetite 54.78 34.58 82 4456 281207 64212987
Prostate cancer recurrent 53.27 34.58 12 4526 733 64493461
Full blood count abnormal 49.40 34.58 29 4509 29728 64464466
Hormone-refractory prostate cancer 43.60 34.58 9 4529 363 64493831
Cancer pain 40.15 34.58 14 4524 4243 64489951
Blood alkaline phosphatase increased 38.91 34.58 32 4506 56247 64437947
Metastases to central nervous system 35.42 34.58 18 4520 13894 64480300

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V10XX03 VARIOUS
THERAPEUTIC RADIOPHARMACEUTICALS
OTHER THERAPEUTIC RADIOPHARMACEUTICALS
Various therapeutic radiopharmaceuticals
MeSH PA D000970 Antineoplastic Agents
CHEBI has role CHEBI:35232 radiopharmaceuticals
CHEBI has role CHEBI:35610 antineoplastic agents

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

DiseaseRelationSNOMED_IDDOID
Malignant tumor of prostate indication 399068003 DOID:10283




🐶 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
162mCi/6ML (27mCi/ML) XOFIGO BAYER HLTHCARE N203971 May 15, 2013 RX SOLUTION INTRAVENOUS 6635234 Nov. 17, 2022 THERAPEUTIC TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER, SYMPTOMATIC BONE METASTASES AND NO KNOWN VISCERAL METASTATIC DISEASE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4037730 VANDF
CHEBI:74895 CHEBI
CHEMBL2107816 ChEMBL_ID
C581106 MESH_SUPPLEMENTAL_RECORD_UI
DB08913 DRUGBANK_ID
RJ00KV3VTG UNII
1424174 RXNORM
203076 MMSL
29462 MMSL
d08101 MMSL
015032 NDDF
C3541342 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Xofigo HUMAN PRESCRIPTION DRUG LABEL 1 50419-208 INJECTION 30 uCi INTRAVENOUS NDA 27 sections