peginterferon alfa-2b Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5164 215647-85-1

Description:

MoleculeDescription

Synonyms:

  • peginterferon alfa-2b
  • pegintron
A covalent conjugate of recombinant interferon alpha, subtype 2b, and polyethylene glycol (PEG), used as an antiviral and antineoplastic agent. The biological activity of this agent is derived from its interferon alpha-2b protein moiety. Interferons alfa bind to specific cell-surface receptors, leading to the transcription and translation of genes whose protein products mediate antiviral, antiproliferative, anticancer, and immune-modulating effects. The PEG moiety lowers the clearance of interferon alpha-2b, thereby extending the duration of its therapeutic effects, but may also reduce the interferon-mediated stimulation of an immune response
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
7.50 mcg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 19, 2001 FDA SCHERING

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
Anaemia 867.79 23.02 637 11810 255142 46418473
White blood cell count decreased 522.60 23.02 341 12106 111890 46561725
Neutrophil count decreased 458.98 23.02 226 12221 43200 46630415
Product quality issue 429.50 23.02 203 12244 35445 46638170
Haemoglobin decreased 402.54 23.02 307 12140 128642 46544973
Platelet count decreased 384.11 23.02 270 12177 99754 46573861
No adverse event 271.45 23.02 147 12300 34084 46639531
Decreased appetite 226.69 23.02 268 12179 193568 46480047
Influenza like illness 192.16 23.02 143 12304 57427 46616188
Retinopathy 189.47 23.02 55 12392 2401 46671214
Hyperuricaemia 146.64 23.02 53 12394 4664 46668951
Hepatitis C 145.54 23.02 57 12390 6261 46667354
Rash 139.25 23.02 298 12149 356214 46317401
Dysgeusia 122.68 23.02 95 12352 40396 46633219
Product dose omission issue 108.56 23.02 175 12272 168345 46505270
Fatigue 102.37 23.02 374 12073 608323 46065292
Pyrexia 96.29 23.02 255 12192 348547 46325068
Nausea 91.08 23.02 392 12055 687062 45986553
Pruritus 89.06 23.02 198 12249 242154 46431461
Drug eruption 75.59 23.02 55 12392 21274 46652341
Blood bilirubin increased 69.98 23.02 64 12383 34120 46639495
Erythema multiforme 69.45 23.02 39 12408 9665 46663950
Chills 69.04 23.02 105 12342 95927 46577688
Malaise 68.90 23.02 219 12228 331013 46342602
Dry skin 61.91 23.02 65 12382 40951 46632664
Death 60.05 23.02 9 12438 335539 46338076
Depression 59.04 23.02 136 12311 169968 46503647
Red blood cell count decreased 53.38 23.02 54 12393 32569 46641046
Rheumatoid arthritis 52.01 23.02 3 12444 240212 46433403
Anorectal discomfort 51.00 23.02 20 12427 2201 46671414
Blood uric acid increased 50.69 23.02 24 12423 4177 46669438
Hepatitis C RNULL increased 50.54 23.02 11 12436 143 46673472
Retinal haemorrhage 50.20 23.02 25 12422 4858 46668757
Drug hypersensitivity 50.00 23.02 4 12443 243821 46429794
Insomnia 49.84 23.02 125 12322 164799 46508816
Proctalgia 44.76 23.02 23 12424 4773 46668842
Toxicity to various agents 41.98 23.02 4 12443 211762 46461853
Headache 40.43 23.02 241 12206 478111 46195504
Underdose 38.81 23.02 36 12411 19522 46654093
Condition aggravated 38.62 23.02 9 12438 245043 46428572
Transfusion 37.77 23.02 30 12417 13201 46660414
Exposure via father 36.81 23.02 10 12437 341 46673274
Hepatocellular carcinoma 36.67 23.02 17 12430 2822 46670793
Fall 35.48 23.02 22 12425 329075 46344540
Weight decreased 34.58 23.02 129 12318 210720 46462895
Renal impairment 34.50 23.02 67 12380 74305 46599310
Anal pruritus 34.36 23.02 11 12436 668 46672947
Haemorrhoids 34.27 23.02 33 12414 18744 46654871
Alopecia 34.18 23.02 108 12339 162306 46511309
Viral load increased 33.76 23.02 13 12434 1362 46672253
Product container issue 33.72 23.02 14 12433 1785 46671830
Vomiting 32.55 23.02 219 12228 452575 46221040
Toxic skin eruption 30.97 23.02 26 12421 12361 46661254
Depressive symptom 30.58 23.02 15 12432 2821 46670794
Joint swelling 28.43 23.02 5 12442 166068 46507547
Peripheral swelling 26.54 23.02 5 12442 158066 46515549
Dry mouth 24.87 23.02 49 12398 54877 46618738
Exposure via partner 24.19 23.02 6 12441 142 46673473
Leukopenia 24.04 23.02 55 12392 68288 46605327
Injection site erythema 23.05 23.02 57 12390 74370 46599245

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
Anaemia 636.77 23.23 632 13941 207360 29730545
White blood cell count decreased 548.80 23.23 396 14177 83551 29854354
Product quality issue 519.57 23.23 229 14344 18545 29919360
Influenza like illness 408.40 23.23 214 14359 25391 29912514
Neutrophil count decreased 385.84 23.23 246 14327 42208 29895697
Rash 383.03 23.23 467 14106 191422 29746483
Hyperuricaemia 301.42 23.23 119 14454 7275 29930630
No adverse event 264.52 23.23 141 14432 17278 29920627
Platelet count decreased 241.70 23.23 277 14296 105852 29832053
Haemoglobin decreased 238.56 23.23 285 14288 113813 29824092
Retinopathy 234.38 23.23 71 14502 1939 29935966
Dysgeusia 191.57 23.23 130 14443 24671 29913234
Fatigue 188.96 23.23 453 14120 320220 29617685
Decreased appetite 164.33 23.23 275 14298 149635 29788270
Hepatitis C 156.89 23.23 91 14482 13114 29924791
Drug eruption 150.09 23.23 98 14475 17428 29920477
Pruritus 140.41 23.23 225 14348 117979 29819926
Death 128.02 23.23 13 14560 357270 29580635
Erythema multiforme 124.97 23.23 66 14507 7919 29929986
Depression 118.21 23.23 180 14393 90257 29847648
Headache 107.16 23.23 258 14315 182048 29755857
Insomnia 103.02 23.23 172 14401 93164 29844741
Product dose omission issue 102.67 23.23 170 14403 91461 29846444
Anal pruritus 93.96 23.23 25 14548 420 29937485
Injection site erythema 93.82 23.23 67 14506 13767 29924138
Hepatocellular carcinoma 90.31 23.23 57 14516 9553 29928352
Nausea 89.08 23.23 331 14242 296626 29641279
Pyrexia 85.61 23.23 325 14248 294164 29643741
Injection site rash 75.21 23.23 36 14537 3503 29934402
Chills 72.76 23.23 128 14445 72210 29865695
Toxicity to various agents 70.16 23.23 4 14569 177179 29760726
Renal disorder 68.18 23.23 70 14503 23514 29914391
Irritability 67.69 23.23 69 14504 22981 29914924
Mood swings 63.68 23.23 42 14531 7584 29930321
Malaise 62.83 23.23 201 14372 166761 29771144
Renal impairment 62.54 23.23 131 14442 84053 29853852
Blood uric acid increased 62.35 23.23 38 14535 5985 29931920
Retinal haemorrhage 59.81 23.23 34 14539 4709 29933196
Underdose 58.53 23.23 48 14525 12093 29925812
Proctalgia 54.21 23.23 31 14542 4341 29933564
Acute kidney injury 53.14 23.23 34 14539 273808 29664097
Injection site reaction 50.74 23.23 42 14531 10718 29927187
Haemorrhoids 50.31 23.23 44 14529 12097 29925808
Anorectal discomfort 49.61 23.23 22 14551 1795 29936110
Fall 48.87 23.23 14 14559 181858 29756047
Injection site pruritus 47.17 23.23 31 14542 5561 29932344
Red blood cell count decreased 45.55 23.23 60 14513 26261 29911644
Hypotension 41.54 23.23 23 14550 200542 29737363
Blood bilirubin increased 37.00 23.23 65 14508 36571 29901334
Completed suicide 34.50 23.23 4 14569 99488 29838417
Depressed mood 29.73 23.23 39 14534 16990 29920915
Myocardial infarction 29.67 23.23 12 14561 125613 29812292
Weight decreased 29.35 23.23 148 14425 150773 29787132
Pneumonia 29.09 23.23 76 14497 334230 29603675
Dry mouth 29.07 23.23 45 14528 22805 29915100
Cerebrovascular accident 27.39 23.23 4 14569 83473 29854432
Off label use 27.16 23.23 50 14523 249240 29688665
Adverse event 26.57 23.23 35 14538 15306 29922599
Alopecia universalis 26.50 23.23 6 14567 49 29937856
General physical health deterioration 26.25 23.23 8 14565 99936 29837969
Hepatitis C RNULL increased 26.20 23.23 9 14564 369 29937536
Alopecia 24.58 23.23 38 14535 19237 29918668
Viral load increased 24.51 23.23 16 14557 2838 29935067
Hepatic amoebiasis 24.50 23.23 6 14567 71 29937834
Condition aggravated 24.19 23.23 19 14554 137847 29800058
Dry skin 24.18 23.23 41 14532 22413 29915492
Hepatic pain 23.97 23.23 12 14561 1286 29936619
Hepatic cirrhosis 23.93 23.23 34 14539 15965 29921940
Drug interaction 23.57 23.23 38 14535 199530 29738375
Sepsis 23.46 23.23 22 14551 146373 29791532
Leukopenia 23.24 23.23 70 14503 56089 29881816

Pharmacologic Action:

SourceCodeDescription
ATC L03AB10 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSTIMULANTS
IMMUNOSTIMULANTS
Interferons
ATC L03AB60 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSTIMULANTS
IMMUNOSTIMULANTS
Interferons
FDA CS M0025711 Interferon-alpha
FDA EPC N0000175521 Interferon alpha
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic hepatitis C indication 128302006

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
Interferon alpha/beta receptor Membrane receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
4021256 VANDF
C0796545 UMLSCUI
CHEMBL1201561 ChEMBL_ID
DB00022 DRUGBANK_ID
C417083 MESH_SUPPLEMENTAL_RECORD_UI
7462 IUPHAR_LIGAND_ID
7909 INN_ID
G8RGG88B68 UNII
253453 RXNORM
15887 MMSL
41030 MMSL
d04746 MMSL
008329 NDDF
129477009 SNOMEDCT_US
395823000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PEGINTRON HUMAN PRESCRIPTION DRUG LABEL 1 0085-1297 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 120 ug SUBCUTANEOUS BLA 32 sections
PEGINTRON HUMAN PRESCRIPTION DRUG LABEL 1 0085-1316 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 80 ug SUBCUTANEOUS BLA 32 sections
PEGINTRON HUMAN PRESCRIPTION DRUG LABEL 1 0085-1323 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 ug SUBCUTANEOUS BLA 32 sections
PEGINTRON HUMAN PRESCRIPTION DRUG LABEL 1 0085-1370 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 ug SUBCUTANEOUS BLA 32 sections