methoxy polyethylene glycol-epoetin beta 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 14, 2007 FDA HOFFMAN-LA ROCHE
July 20, 2007 EMA Roche Registration GmbH

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 3951.38 34.40 1615 9569 461994 90155269
Flushing 613.29 34.40 271 10913 88220 90529043
Dyspnoea 476.00 34.40 560 10624 880395 89736868
Pruritus 443.35 34.40 430 10754 541095 90076168
Aplasia pure red cell 385.93 34.40 96 11088 5098 90612165
Death 371.98 34.40 362 10822 456189 90161074
Unresponsive to stimuli 361.13 34.40 146 11038 37975 90579288
Feeling hot 349.24 34.40 177 11007 77831 90539432
Vomiting 254.13 34.40 391 10793 787902 89829361
Nausea 251.42 34.40 470 10714 1109846 89507417
Haemoglobin decreased 236.76 34.40 180 11004 161776 90455487
No adverse event 224.39 34.40 126 11058 67856 90549407
Marasmus 140.79 34.40 30 11154 793 90616470
Inappropriate schedule of product administration 138.61 34.40 128 11056 149805 90467458
Pulse absent 116.06 34.40 39 11145 6016 90611247
Back pain 106.50 34.40 161 11023 317014 90300249
Shunt occlusion 92.34 34.40 21 11163 754 90616509
Blood pressure decreased 83.17 34.40 71 11113 74824 90542439
Shunt stenosis 76.70 34.40 17 11167 542 90616721
Drug ineffective 73.53 34.40 40 11144 1384258 89233005
Erythema 66.61 34.40 109 11075 229137 90388126
Chest pain 58.95 34.40 125 11059 319520 90297743
Haemoglobin increased 58.42 34.40 25 11159 7456 90609807
Agonal respiration 56.57 34.40 11 11173 181 90617082
Hypotension 56.28 34.40 124 11060 325273 90291990
Serum ferritin increased 55.45 34.40 24 11160 7357 90609906
Hyperhidrosis 54.09 34.40 75 11109 136230 90481033
Arthralgia 49.91 34.40 17 11167 778505 89838758
Off label use 48.73 34.40 39 11145 1102213 89515050
Blood pressure increased 47.07 34.40 86 11098 197131 90420132
Cardiac failure 46.08 34.40 62 11122 109434 90507829
Urticaria 45.10 34.40 111 11073 312623 90304640
Loss of consciousness 43.86 34.40 69 11115 140169 90477094
Seizure like phenomena 43.44 34.40 13 11171 1377 90615886
Throat tightness 43.44 34.40 33 11151 29451 90587812
Chest discomfort 41.78 34.40 67 11117 138298 90478965
Fatigue 41.53 34.40 49 11135 1153974 89463289
Alopecia 41.31 34.40 6 11178 495065 90122198
Anaemia 38.53 34.40 113 11071 352689 90264574
Infusion related reaction 37.32 34.40 4 11180 416776 90200487
Reticulocyte count decreased 36.39 34.40 9 11175 465 90616798

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 3874.07 28.31 1302 10026 98087 42511920
Flushing 487.89 28.31 224 11104 36804 42573203
Aplasia pure red cell 468.70 28.31 141 11187 7025 42602982
Pruritus 391.96 28.31 354 10974 188417 42421590
Death 333.77 28.31 507 10821 470678 42139329
Dyspnoea 299.99 28.31 467 10861 442154 42167853
Feeling hot 299.38 28.31 139 11189 23343 42586664
No adverse event 261.98 28.31 150 11178 38871 42571136
Haemoglobin decreased 223.55 28.31 222 11106 132249 42477758
Unresponsive to stimuli 216.84 28.31 123 11205 31280 42578727
Nausea 125.07 28.31 304 11024 396495 42213512
Haemoglobin increased 116.65 28.31 46 11282 5160 42604847
Vomiting 114.49 28.31 243 11085 289480 42320527
Inappropriate schedule of product administration 98.09 28.31 124 11204 95778 42514229
Blood iron decreased 85.41 28.31 39 11289 6279 42603728
Erythema 84.39 28.31 123 11205 108670 42501337
Urticaria 76.08 28.31 96 11232 73940 42536067
Hyperhidrosis 74.07 28.31 105 11223 90407 42519600
Serum ferritin increased 71.52 28.31 36 11292 7183 42602824
Blood pressure decreased 70.28 28.31 82 11246 58250 42551757
Off label use 68.35 28.31 43 11285 638292 41971715
Pulse absent 66.96 28.31 33 11295 6294 42603713
Drug ineffective 54.10 28.31 53 11275 630144 41979863
Seizure like phenomena 52.42 28.31 17 11311 1080 42608927
Marasmus 51.52 28.31 16 11312 883 42609124
Ventricular hyperkinesia 51.02 28.31 12 11316 226 42609781
Right atrial enlargement 48.74 28.31 12 11316 276 42609731
Hypochromasia 47.08 28.31 12 11316 319 42609688
Agonal respiration 44.01 28.31 9 11319 85 42609922
Mitral valve thickening 42.66 28.31 12 11316 468 42609539
Throat tightness 41.66 28.31 28 11300 9571 42600436
Mean platelet volume increased 39.18 28.31 12 11316 632 42609375
Reticulocyte count decreased 38.11 28.31 12 11316 693 42609314
Left ventricular enlargement 36.15 28.31 12 11316 820 42609187
Weight decreased 36.05 28.31 6 11322 207942 42402065
Drug interaction 36.05 28.31 13 11315 266986 42343021
Chest pain 35.47 28.31 99 11229 139431 42470576
Shunt occlusion 33.68 28.31 12 11316 1015 42608992
Left atrial enlargement 33.59 28.31 12 11316 1023 42608984
Hypertension 30.75 28.31 106 11222 167098 42442909
Chest discomfort 30.48 28.31 58 11270 63558 42546449
Anaemia 29.03 28.31 149 11179 280129 42329878
Acute kidney injury 29.02 28.31 33 11295 367304 42242703
Dizziness 29.01 28.31 137 11191 249117 42360890
Shunt stenosis 29.01 28.31 10 11318 767 42609240
High density lipoprotein decreased 28.85 28.31 16 11312 3881 42606126
Back pain 28.84 28.31 93 11235 141683 42468324
Product use in unapproved indication 28.48 28.31 7 11321 184449 42425558

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
Drug hypersensitivity 7556.81 28.25 2872 17579 451218 110117630
Flushing 1104.90 28.25 486 19965 104250 110464598
Pruritus 838.27 28.25 757 19694 580803 109988045
Dyspnoea 785.72 28.25 987 19464 1105885 109462963
Feeling hot 611.79 28.25 310 20141 90796 110478052
Unresponsive to stimuli 579.29 28.25 267 20184 63523 110505325
Aplasia pure red cell 567.46 28.25 161 20290 9417 110559431
No adverse event 445.69 28.25 234 20217 73605 110495243
Nausea 374.23 28.25 748 19703 1234942 109333906
Vomiting 343.14 28.25 606 19845 910069 109658779
Haemoglobin decreased 255.09 28.25 270 20181 248457 110320391
Inappropriate schedule of product administration 232.07 28.25 234 20217 203403 110365445
Death 224.50 28.25 435 20016 698434 109870414
Pulse absent 185.11 28.25 72 20379 11220 110557628
Blood pressure decreased 170.50 28.25 153 20298 114938 110453910
Marasmus 154.41 28.25 40 20411 1651 110567197
Erythema 154.03 28.25 227 20224 291220 110277628
Back pain 143.99 28.25 251 20200 370745 110198103
Hyperhidrosis 143.60 28.25 175 20276 187123 110381725
Drug ineffective 119.22 28.25 67 20384 1520473 109048375
Serum ferritin increased 111.77 28.25 51 20400 11796 110557052
Off label use 100.17 28.25 79 20372 1500106 109068742
Urticaria 97.65 28.25 195 20256 318662 110250186
Agonal respiration 96.28 28.25 20 20431 304 110568544
Haemoglobin increased 94.64 28.25 42 20409 9105 110559743
Shunt stenosis 93.83 28.25 26 20425 1390 110567458
Chest pain 93.11 28.25 211 20240 376164 110192684
Seizure like phenomena 92.19 28.25 29 20422 2412 110566436
Shunt occlusion 88.57 28.25 26 20425 1711 110567137
Throat tightness 87.10 28.25 62 20389 33427 110535421
Hypotension 78.80 28.25 244 20207 523605 110045243
Arthralgia 77.50 28.25 24 20427 779608 109789240
Chest discomfort 75.74 28.25 124 20327 173724 110395124
Blood pressure increased 73.12 28.25 153 20298 258220 110310628
Blood iron decreased 70.31 28.25 44 20407 19170 110549678
Loss of consciousness 69.81 28.25 128 20323 196178 110372670
Condition aggravated 59.35 28.25 31 20420 734805 109834043
Fatigue 57.66 28.25 85 20366 1215873 109352975
Cardiac failure 55.27 28.25 113 20338 187513 110381335
Infusion related reaction 55.12 28.25 4 20447 381158 110187690
Weight decreased 55.12 28.25 10 20441 468047 110100801
Ventricular hyperkinesia 51.77 28.25 12 20439 309 110568539
Weight increased 47.23 28.25 10 20441 419634 110149214
Heart rate increased 46.40 28.25 90 20361 143744 110425104
Right atrial enlargement 46.11 28.25 12 20439 504 110568344
Hepatic enzyme increased 44.63 28.25 4 20447 320888 110247960
Depression 44.01 28.25 4 20447 317331 110251517
Sinusitis 43.21 28.25 3 20448 296685 110272163
Hypochromasia 42.28 28.25 12 20439 700 110568148
Dizziness 42.03 28.25 246 20205 697947 109870901
Insomnia 41.80 28.25 8 20443 360582 110208266
Mitral valve thickening 41.37 28.25 12 20439 757 110568091
Anaemia 40.50 28.25 204 20247 546882 110021966
Drug interaction 40.49 28.25 21 20430 500162 110068686
Alopecia 40.41 28.25 9 20442 364744 110204104
Left ventricular enlargement 39.89 28.25 12 20439 859 110567989
Chronic kidney disease 39.57 28.25 59 20392 76232 110492616
Peripheral swelling 39.08 28.25 13 20438 404021 110164827
Product use in unapproved indication 38.94 28.25 17 20434 447360 110121488
Reticulocyte count decreased 38.67 28.25 12 20439 954 110567894
Rheumatoid arthritis 38.44 28.25 5 20446 299608 110269240
Pallor 37.23 28.25 49 20402 56418 110512430
High density lipoprotein decreased 36.90 28.25 19 20432 5714 110563134
Hypertension 36.20 28.25 188 20263 509896 110058952
Nasopharyngitis 35.91 28.25 14 20437 394347 110174501
Systemic lupus erythematosus 35.83 28.25 3 20448 254335 110314513
Anaphylactic reaction 35.02 28.25 70 20381 114230 110454618
Anti-erythropoietin antibody positive 33.20 28.25 10 20441 719 110568129
Blood parathyroid hormone increased 33.01 28.25 16 20435 4232 110564616
Mean platelet volume increased 32.70 28.25 12 20439 1592 110567256
Asthma 32.54 28.25 4 20447 250287 110318561
Left atrial enlargement 31.81 28.25 12 20439 1719 110567129
Transferrin decreased 31.48 28.25 9 20442 539 110568309
Lower respiratory tract infection 31.32 28.25 4 20447 243102 110325746
Pyrexia 30.89 28.25 76 20375 898189 109670659
Pain in extremity 30.65 28.25 27 20424 487091 110081757
Therapeutic product effect incomplete 30.55 28.25 3 20448 223802 110345046
Mobility decreased 30.36 28.25 4 20447 237418 110331430
Wound 29.86 28.25 4 20447 234433 110334415
Confusional state 29.46 28.25 26 20425 468654 110100194
Blood urea increased 29.21 28.25 43 20408 54914 110513934
Documented hypersensitivity to administered product 28.86 28.25 10 20441 1124 110567724
Blood phosphorus increased 28.77 28.25 24 20427 16316 110552532

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B03XA03 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
OTHER ANTIANEMIC PREPARATIONS
Other antianemic preparations
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

B03XA Other antianemic preparations 8 drugs
daprodustatdarbepoetin alfaepoetin alfaluspaterceptmolidustatpeginesatideroxadustatvadadustat

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

DiseaseRelationSNOMED_IDDOID
Anemia in chronic kidney disease indication 707323002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
CHEBI:755792 CHEBI
CHEMBL3707314 ChEMBL_ID
DB09107 DRUGBANK_ID
C508420 MESH_SUPPLEMENTAL_RECORD_UI
1591957 RXNORM
425913002 SNOMEDCT_US
426360006 SNOMEDCT_US
120086 MMSL
24326 MMSL
d06911 MMSL
012324 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-400 INJECTION, SOLUTION 30 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-401 INJECTION, SOLUTION 50 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-402 INJECTION, SOLUTION 75 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-403 INJECTION, SOLUTION 100 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-404 INJECTION, SOLUTION 150 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-405 INJECTION, SOLUTION 200 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-406 INJECTION, SOLUTION 250 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-407 INJECTION, SOLUTION 120 ug INTRAVENOUS BLA 31 sections
Mircera HUMAN PRESCRIPTION DRUG LABEL 1 59353-408 INJECTION, SOLUTION 360 ug INTRAVENOUS BLA 31 sections