methoxy polyethylene glycol-epoetin beta Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
erythropoietin type blood factors 5165 677324-53-7

Description:

MoleculeDescription

Synonyms:

  • methoxy polyethylene glycol-epoetin beta
  • mircera
A pegylated form of recombinant human erythropoietin, a glycosylated protein naturally produced in the kidney that stimulates erythrocyte production in the bone marrow. Methoxypolyethylene glycol epoetin beta may reverse anemias induced by cancer therapy
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
4 mcg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Nov. 14, 2007 FDA HOFFMAN-LA ROCHE

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
Drug hypersensitivity 1605.32 32.34 746 6325 264496 53077499
Pruritus 362.60 32.34 303 6768 293529 53048466
Flushing 279.73 32.34 151 6920 70449 53271546
No adverse event 278.58 32.34 125 6946 39140 53302855
Aplasia pure red cell 277.37 32.34 73 6998 4523 53337472
Death 240.39 32.34 264 6807 356968 52985027
Inappropriate schedule of product administration 189.89 32.34 120 6951 74758 53267237
Dyspnoea 179.68 32.34 295 6776 585937 52756058
Haemoglobin decreased 166.96 32.34 141 6930 137166 53204829
Marasmus 144.62 32.34 29 7042 523 53341472
Feeling hot 121.50 32.34 73 6998 41471 53300524
Vomiting 116.54 32.34 223 6848 496916 52845079
Nausea 95.87 32.34 266 6805 755825 52586170
Unresponsive to stimuli 90.68 32.34 56 7015 33370 53308625
Shunt occlusion 69.92 32.34 16 7055 549 53341446
Urticaria 56.08 32.34 79 6992 135806 53206189
Shunt stenosis 53.19 32.34 12 7059 386 53341609
Cardiac failure 48.00 32.34 58 7013 85786 53256209
Anaemia 43.52 32.34 106 6965 276612 53065383
Chest pain 38.98 32.34 81 6990 190104 53151891
Blood pressure decreased 36.54 32.34 43 7028 61826 53280169
Drug ineffective 34.16 32.34 35 7036 817210 52524785

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
Drug hypersensitivity 1359.46 28.92 541 7090 72859 32433036
Aplasia pure red cell 365.70 28.92 108 7523 5734 32500161
No adverse event 358.04 28.92 145 7486 19908 32485987
Death 274.16 28.92 387 7244 382130 32123765
Pruritus 271.82 28.92 231 7400 128471 32377424
Flushing 221.20 28.92 119 7512 31008 32474887
Inappropriate schedule of product administration 183.43 28.92 121 7510 45704 32460191
Haemoglobin decreased 182.12 28.92 179 7452 119492 32386403
Dyspnoea 115.51 28.92 258 7373 361787 32144108
Unresponsive to stimuli 96.23 28.92 67 7564 27542 32478353
Feeling hot 85.97 28.92 52 7579 16834 32489061
Marasmus 58.88 28.92 16 7615 623 32505272
Anaemia 58.52 28.92 148 7483 223476 32282419
Haemoglobin increased 57.32 28.92 23 7608 3059 32502836
Ventricular hyperkinesia 52.01 28.92 12 7619 236 32505659
Right atrial enlargement 50.91 28.92 12 7619 260 32505635
Hypochromasia 47.73 28.92 12 7619 343 32505552
Urticaria 47.46 28.92 64 7567 59550 32446345
Mitral valve thickening 45.45 28.92 12 7619 418 32505477
Mean platelet volume increased 44.22 28.92 12 7619 465 32505430
Nausea 43.50 28.92 169 7462 320680 32185215
Blood iron decreased 41.99 28.92 21 7610 4683 32501212
Hypertension 41.70 28.92 94 7537 131656 32374239
Left atrial enlargement 40.43 28.92 12 7619 644 32505251
Left ventricular enlargement 40.31 28.92 12 7619 651 32505244
Vomiting 36.81 28.92 130 7501 235427 32270468
Nephrogenic anaemia 35.59 28.92 15 7616 2258 32503637
Cardiac failure 31.91 28.92 68 7563 91605 32414290
Shunt occlusion 30.65 28.92 10 7621 735 32505160
Erythema 30.50 28.92 63 7568 83042 32422853
Blood pressure decreased 29.28 28.92 47 7584 51033 32454862
Serum ferritin increased 29.07 28.92 18 7613 6061 32499834

Pharmacologic Action:

SourceCodeDescription
ATC B03XA03 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
OTHER ANTIANEMIC PREPARATIONS
Other antianemic preparations

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Anemia in chronic kidney disease indication 707323002

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Erythropoietin receptor Membrane receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
LR3UXN0193 UNII
4026967 VANDF
C1328071 UMLSCUI
CHEMBL3707314 ChEMBL_ID
DB09107 DRUGBANK_ID
C508420 MESH_SUPPLEMENTAL_RECORD_UI
1591957 RXNORM
120086 MMSL
24326 MMSL
d06911 MMSL
012324 NDDF
425913002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-400 INJECTION, SOLUTION 30 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-401 INJECTION, SOLUTION 50 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-402 INJECTION, SOLUTION 75 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-403 INJECTION, SOLUTION 100 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-404 INJECTION, SOLUTION 150 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-405 INJECTION, SOLUTION 200 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-406 INJECTION, SOLUTION 250 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-407 INJECTION, SOLUTION 120 ug INTRAVENOUS BLA 29 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-408 INJECTION, SOLUTION 360 ug INTRAVENOUS BLA 29 sections