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

Stem definitionDrug idCAS RN
4498 199739-10-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • paliperidone palmitate
  • RO92670
  • invega sustenna
A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.
  • Molecular weight: 664.91
  • Formula: C39H57FN4O4
  • CLOGP: 9.34
  • LIPINSKI: 2
  • HAC: 8
  • HDO: 0
  • TPSA: 88.24
  • ALOGS: -4.98
  • ROTB: 20
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
S (Water solubility) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 28 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MET,NTRK2,PDK2,PDK4,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,TEK,TGFBR1 32
kinase-selectivity-class AXL,CDK4,EIF2AK3,EPHB4,GRK2,STK33,TEK 7
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.092 Moderate 0.65
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 Moderate 0.73
rat-kpuu-brain Rat brain Kpuu 70.795 % Moderate 0.65

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 2013 PMDA JANSSEN PHARMACEUTICAL K.K.
July 31, 2009 FDA JANSSEN PHARMS

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
Blood prolactin increased 2233.17 28.81 415 17332 3222 90607478
Galactorrhoea 2117.16 28.81 413 17334 4259 90606441
Amenorrhoea 1200.98 28.81 307 17440 11415 90599285
Injection site nodule 1036.86 28.81 227 17520 4246 90606454
Product dose omission issue 768.87 28.81 554 17193 291133 90319567
Hospitalisation 722.84 28.81 395 17352 127705 90482995
Blood prolactin abnormal 686.34 28.81 153 17594 3113 90607587
Psychotic disorder 554.14 28.81 214 17533 31016 90579684
Disturbance in social behaviour 545.11 28.81 133 17614 4055 90606645
Inappropriate schedule of product administration 502.78 28.81 331 17416 149602 90461098
Anosognosia 495.01 28.81 119 17628 3403 90607297
Sexual dysfunction 487.55 28.81 125 17622 4679 90606021
Hyperprolactinaemia 486.65 28.81 128 17619 5305 90605395
Dystonia 461.41 28.81 159 17588 16660 90594040
Hallucination, auditory 434.26 28.81 150 17597 15825 90594875
Metabolic disorder 424.00 28.81 123 17624 7347 90603353
Treatment noncompliance 413.72 28.81 202 17545 51525 90559175
Akathisia 407.90 28.81 131 17616 11028 90599672
Personality change 395.44 28.81 116 17631 7205 90603495
Extrapyramidal disorder 385.48 28.81 138 17609 16165 90594535
Sedation 375.89 28.81 185 17562 47986 90562714
Dyskinesia 363.82 28.81 166 17581 36368 90574332
Injection site mass 358.62 28.81 142 17605 21948 90588752
Off label use 340.15 28.81 695 17052 1101557 89509143
Incorrect dose administered 313.15 28.81 194 17553 78736 90531964
Breast discharge 292.15 28.81 64 17683 1195 90609505
Suicide attempt 285.67 28.81 180 17567 75219 90535481
Psychotic symptom 270.02 28.81 67 17680 2189 90608511
Weight increased 263.34 28.81 364 17383 417563 90193137
Syringe issue 254.40 28.81 72 17675 3930 90606770
Delusion 242.30 28.81 94 17653 13746 90596954
Tardive dyskinesia 222.93 28.81 83 17664 10847 90599853
Refusal of treatment by patient 208.15 28.81 67 17680 5671 90605029
Paranoia 202.54 28.81 81 17666 12827 90597873
Blood glucose increased 192.39 28.81 155 17592 95091 90515609
Injection site pain 180.26 28.81 195 17552 173504 90437196
Aggression 163.14 28.81 87 17660 26581 90584119
Device leakage 127.20 28.81 54 17693 9937 90600763
Product administered at inappropriate site 124.55 28.81 42 17705 4109 90606591
Underdose 122.12 28.81 94 17653 53923 90556777
Therapeutic response decreased 118.89 28.81 115 17632 89614 90521086
Diarrhoea 113.83 28.81 23 17724 939167 89671533
Drooling 109.35 28.81 39 17708 4507 90606193
Nausea 107.24 28.81 42 17705 1110274 89500426
Injection site abscess 100.78 28.81 28 17719 1426 90609274
Arthralgia 96.51 28.81 18 17729 778504 89832196
Hallucination 95.86 28.81 89 17658 65870 90544830
Pain 95.64 28.81 38 17709 996303 89614397
Neuroleptic malignant syndrome 94.43 28.81 50 17697 15046 90595654
Parkinsonism 92.00 28.81 48 17699 14017 90596683
Product use in unapproved indication 90.81 28.81 202 17545 336034 90274666
Abnormal behaviour 90.56 28.81 56 17691 22572 90588128
Tremor 88.00 28.81 128 17619 153045 90457655
Suicidal ideation 85.52 28.81 88 17659 73767 90536933
Injection site induration 77.97 28.81 39 17708 10429 90600271
Injection site swelling 77.93 28.81 76 17671 59763 90550937
Abdominal discomfort 77.09 28.81 4 17743 477324 90133376
Insurance issue 76.29 28.81 39 17708 10919 90599781
Joint swelling 76.01 28.81 6 17741 503294 90107406
Needle issue 75.60 28.81 42 17705 13892 90596808
Injection site reaction 74.49 28.81 91 17656 91989 90518711
Drug ineffective 71.33 28.81 488 17259 1383810 89226890
Personality change due to a general medical condition 68.71 28.81 15 17732 275 90610425
Headache 66.19 28.81 44 17703 862702 89747998
Drug hypersensitivity 66.05 28.81 7 17740 463602 90147098
Breast enlargement 65.72 28.81 21 17726 1734 90608966
Condition aggravated 65.66 28.81 260 17487 595285 90015415
Mania 64.37 28.81 38 17709 14086 90596614
Drug intolerance 63.14 28.81 7 17740 447584 90163116
Schizophrenia 62.46 28.81 38 17709 14876 90595824
Catatonia 61.73 28.81 28 17719 6028 90604672
Breast tenderness 61.28 28.81 22 17725 2590 90608110
Accidental exposure to product 61.22 28.81 57 17690 42309 90568391
Product administration error 59.73 28.81 46 17701 26377 90584323
Psychiatric decompensation 59.63 28.81 20 17727 1923 90608777
Nasopharyngitis 58.35 28.81 6 17741 407098 90203602
Prolactin-producing pituitary tumour 57.82 28.81 11 17736 97 90610603
Fatigue 57.46 28.81 86 17661 1153937 89456763
Menstruation irregular 57.02 28.81 29 17718 8031 90602669
Lactation disorder 56.92 28.81 14 17733 440 90610260
Wrong technique in product usage process 56.69 28.81 70 17677 71501 90539199
Product leakage 53.35 28.81 17 17730 1391 90609309
Product quality issue 51.00 28.81 70 17677 79255 90531445
Imprisonment 50.33 28.81 12 17735 330 90610370
Dyspnoea 49.50 28.81 60 17687 880895 89729805
Adverse drug reaction 48.31 28.81 84 17663 116617 90494083
Pruritus 48.09 28.81 23 17724 541502 90069198
Abdominal pain 47.14 28.81 10 17737 395711 90214989
Vomiting 46.08 28.81 52 17695 788241 89822459
Cough 44.62 28.81 9 17738 368953 90241747
Muscle rigidity 43.95 28.81 30 17717 14279 90596421
Infection 43.44 28.81 9 17738 362085 90248615
Hepatic enzyme increased 43.20 28.81 9 17738 360727 90249973
Abnormal weight gain 42.75 28.81 17 17730 2648 90608052
Flat affect 42.36 28.81 15 17732 1696 90609004
Blunted affect 42.23 28.81 10 17737 267 90610433
Social avoidant behaviour 41.96 28.81 18 17729 3395 90607305
Pyrexia 41.46 28.81 41 17706 660444 89950256
Alopecia 41.01 28.81 23 17724 495048 90115652
Abdominal pain upper 40.46 28.81 8 17739 332666 90278034
Oculogyric crisis 40.42 28.81 16 17731 2463 90608237
Psychiatric symptom 40.10 28.81 22 17725 7096 90603604
Agitation 39.84 28.81 57 17690 67041 90543659
Death 39.20 28.81 185 17562 456366 90154334
Pituitary tumour benign 39.15 28.81 15 17732 2117 90608583
Blister 38.56 28.81 3 17744 254995 90355705
Swelling 38.42 28.81 17 17730 419041 90191659
Contraindicated product administered 38.30 28.81 8 17739 320131 90290569
Anaemia 37.97 28.81 11 17736 352791 90257909
Rash 37.91 28.81 61 17686 796039 89814661
Hypersensitivity 37.83 28.81 21 17726 454656 90156044
Treatment failure 37.61 28.81 7 17740 303921 90306779
Asthenia 37.23 28.81 30 17717 533721 90076979
Adverse event 36.74 28.81 75 17672 117343 90493357
Maternal exposure during pregnancy 35.62 28.81 13 17734 360050 90250650
Pituitary tumour 34.31 28.81 11 17736 918 90609782
Device malfunction 33.78 28.81 30 17717 20947 90589753
Poor personal hygiene 33.76 28.81 9 17738 392 90610308
Breast engorgement 33.51 28.81 7 17740 103 90610597
Irritability 33.38 28.81 38 17709 35624 90575076
Restlessness 33.33 28.81 38 17709 35682 90575018
Peripheral swelling 33.05 28.81 20 17727 413086 90197614
Discomfort 32.52 28.81 7 17740 274328 90336372
Terminal dribbling 31.58 28.81 5 17742 12 90610688
Injection site infection 31.00 28.81 13 17734 2319 90608381
Back pain 30.45 28.81 12 17735 317163 90293537
Injection site erythema 29.73 28.81 62 17685 98440 90512260
Exposure to contaminated device 29.65 28.81 5 17742 20 90610680
Hypertension 29.14 28.81 28 17719 457504 90153196
Asthma 29.07 28.81 6 17741 242154 90368546
Intentional product use issue 29.06 28.81 4 17743 216888 90393812
Decreased appetite 29.06 28.81 19 17728 376521 90234179

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
Product dose omission issue 1645.62 26.30 1046 23372 153319 42443598
Hospitalisation 1339.59 26.30 710 23708 73620 42523297
Inappropriate schedule of product administration 946.52 26.30 621 23797 95281 42501636
Psychotic disorder 905.36 26.30 405 24013 28803 42568114
Blood prolactin increased 751.75 26.30 189 24229 2109 42594808
Treatment noncompliance 705.48 26.30 370 24048 37302 42559615
Hallucination, auditory 604.60 26.30 250 24168 14614 42582303
Gynaecomastia 561.09 26.30 226 24192 12341 42584576
Akathisia 490.97 26.30 195 24223 10256 42586661
Injection site nodule 462.66 26.30 127 24291 2034 42594883
Incorrect dose administered 454.06 26.30 315 24103 52659 42544258
Extrapyramidal disorder 430.84 26.30 203 24215 16209 42580708
Off label use 425.43 26.30 1043 23375 637292 41959625
Psychotic symptom 374.10 26.30 110 24308 2280 42594637
Therapeutic response decreased 364.53 26.30 240 24178 36772 42560145
Weight increased 355.59 26.30 370 24048 107613 42489304
Paranoia 354.35 26.30 169 24249 13857 42583060
Delusion 322.59 26.30 161 24257 14573 42582344
Sexual dysfunction 316.68 26.30 126 24292 6649 42590268
Aggression 301.61 26.30 229 24189 43934 42552983
Syringe issue 301.36 26.30 130 24288 8426 42588491
Underdose 289.78 26.30 156 24262 16510 42580407
Refusal of treatment by patient 274.02 26.30 106 24312 5185 42591732
Dystonia 271.86 26.30 137 24281 12653 42584264
Blood prolactin abnormal 230.42 26.30 63 24355 992 42595925
Therapeutic product effect decreased 228.32 26.30 185 24233 38965 42557952
Abnormal behaviour 225.63 26.30 157 24261 26294 42570623
Tardive dyskinesia 217.23 26.30 97 24321 6827 42590090
Neuroleptic malignant syndrome 210.67 26.30 139 24279 21333 42575584
Sedation 203.49 26.30 156 24262 30319 42566598
Disturbance in social behaviour 180.76 26.30 59 24359 1744 42595173
Anosognosia 171.95 26.30 50 24368 994 42595923
Erectile dysfunction 169.53 26.30 129 24289 24784 42572133
Suicidal ideation 168.94 26.30 171 24247 47990 42548927
Drooling 166.86 26.30 70 24348 4229 42592688
Drug ineffective 164.76 26.30 753 23665 629444 41967473
Galactorrhoea 162.43 26.30 41 24377 464 42596453
Dyskinesia 160.83 26.30 126 24292 25264 42571653
Product administered at inappropriate site 160.16 26.30 62 24356 3036 42593881
Schizophrenia 156.56 26.30 89 24329 10461 42586456
Injection site pain 151.55 26.30 176 24242 57622 42539295
Diarrhoea 143.99 26.30 43 24375 460806 42136111
Needle issue 138.66 26.30 77 24341 8650 42588267
Mania 130.23 26.30 79 24339 10468 42586449
Injection site mass 129.01 26.30 73 24345 8502 42588415
Product leakage 125.87 26.30 37 24381 765 42596152
Hallucination 124.54 26.30 159 24259 57348 42539569
Product administration error 120.42 26.30 93 24325 18250 42578667
Breast enlargement 116.61 26.30 31 24387 436 42596481
Hyperprolactinaemia 115.14 26.30 44 24374 2079 42594838
Acute kidney injury 113.30 26.30 35 24383 367302 42229615
Device leakage 111.70 26.30 71 24347 10214 42586703
Product quality issue 111.62 26.30 88 24330 17794 42579123
Parkinsonism 107.15 26.30 70 24348 10553 42586364
Psychosexual disorder 105.51 26.30 23 24395 128 42596789
Suicide attempt 105.42 26.30 131 24287 45969 42550948
Wrong technique in product usage process 100.46 26.30 123 24295 42512 42554405
Metabolic disorder 95.04 26.30 49 24369 4739 42592178
Agitation 94.89 26.30 148 24270 64166 42532751
Imprisonment 93.61 26.30 28 24390 616 42596301
Anaemia 93.27 26.30 23 24395 280255 42316662
Adverse event 92.22 26.30 89 24329 23551 42573366
Retrograde ejaculation 89.78 26.30 26 24392 509 42596408
Sepsis 87.89 26.30 7 24411 199327 42397590
Condition aggravated 84.83 26.30 334 24084 260420 42336497
Muscle rigidity 81.02 26.30 62 24356 11997 42584920
Abdominal pain 77.87 26.30 9 24409 190462 42406455
Psychiatric symptom 77.32 26.30 41 24377 4200 42592717
Accidental exposure to product 76.22 26.30 75 24343 20318 42576599
Catatonia 75.14 26.30 46 24372 6193 42590724
Anxiety 74.71 26.30 191 24227 118369 42478548
Injection site reaction 74.53 26.30 66 24352 15655 42581262
Nausea 74.21 26.30 71 24347 396728 42200189
Dyspnoea 73.01 26.30 88 24330 442533 42154384
Personality change 68.45 26.30 42 24376 5677 42591240
Pyrexia 67.47 26.30 76 24342 393966 42202951
Toxicity to various agents 66.73 26.30 24 24394 229112 42367805
Priapism 66.52 26.30 43 24375 6364 42590553
Eye movement disorder 66.13 26.30 39 24379 4906 42592011
Social avoidant behaviour 65.54 26.30 34 24384 3330 42593587
Product use issue 65.14 26.30 139 24279 76612 42520305
Thinking abnormal 64.53 26.30 44 24374 7117 42589800
Mental impairment 60.97 26.30 53 24365 12264 42584653
Persecutory delusion 60.89 26.30 33 24385 3531 42593386
Pneumonia 59.47 26.30 94 24324 422055 42174862
Arthralgia 58.90 26.30 22 24396 205216 42391701
Irritability 58.06 26.30 76 24342 28052 42568865
Depression 57.71 26.30 167 24251 111196 42485721
Cough 56.54 26.30 16 24402 178087 42418830
Restlessness 55.74 26.30 76 24342 29173 42567744
Wrong product administered 55.50 26.30 38 24380 6188 42590729
Emotional disorder 55.01 26.30 38 24380 6276 42590641
Breast tenderness 54.96 26.30 20 24398 823 42596094
Substance abuse 51.67 26.30 42 24376 8863 42588054
Flat affect 50.74 26.30 20 24398 1027 42595890
Oculogyric crisis 49.88 26.30 23 24395 1742 42595175
Mental disorder 49.03 26.30 56 24362 17973 42578944
Rash 48.89 26.30 52 24366 276902 42320015
Breast discharge 48.58 26.30 10 24408 40 42596877
Pruritus 48.16 26.30 24 24394 188747 42408170
Tremor 47.95 26.30 143 24275 96786 42500131
Ejaculation failure 47.66 26.30 18 24400 823 42596094
Fatigue 46.63 26.30 114 24304 435527 42161390
Intentional self-injury 46.13 26.30 50 24368 15152 42581765
Haemoglobin decreased 45.72 26.30 10 24408 132461 42464456
Homicidal ideation 45.32 26.30 25 24393 2769 42594148
Incorrect route of product administration 44.57 26.30 62 24356 24243 42572674
Atrial fibrillation 43.45 26.30 13 24405 139580 42457337
Infection 41.76 26.30 7 24411 112061 42484856
Respiratory failure 41.61 26.30 11 24407 128121 42468796
Asthenia 40.92 26.30 61 24357 280732 42316185
Blood creatinine increased 40.70 26.30 7 24411 109996 42486921
Self-medication 39.12 26.30 24 24394 3242 42593675
Investigation 38.89 26.30 16 24402 919 42595998
Neuropathy peripheral 38.76 26.30 6 24412 101847 42495070
Hypotension 38.48 26.30 55 24363 257576 42339341
Product packaging issue 38.32 26.30 15 24403 756 42596161
Libido decreased 38.22 26.30 28 24390 5070 42591847
Adverse drug reaction 37.92 26.30 73 24345 37361 42559556
Completed suicide 37.44 26.30 131 24287 96334 42500583
Renal failure 37.06 26.30 18 24400 143708 42453209
Vomiting 36.61 26.30 69 24349 289654 42307263
Insomnia 36.32 26.30 149 24269 118104 42478813
Multiple organ dysfunction syndrome 36.29 26.30 6 24412 97029 42499888
Blunted affect 35.82 26.30 12 24406 385 42596532
Schizoaffective disorder 35.78 26.30 19 24399 1951 42594966
Thrombocytopenia 35.51 26.30 34 24384 190245 42406672
Apathy 35.34 26.30 33 24385 8373 42588544
Tobacco user 35.03 26.30 13 24405 566 42596351
Interstitial lung disease 33.87 26.30 3 24415 78459 42518458
Expired product administered 33.81 26.30 24 24394 4139 42592778
Physical assault 33.42 26.30 15 24403 1067 42595850
Drug hypersensitivity 33.29 26.30 8 24410 99381 42497536
Pancytopenia 33.11 26.30 13 24405 117730 42479187
Pain 32.09 26.30 57 24361 244791 42352126
Platelet count decreased 31.89 26.30 20 24398 138561 42458356
Acute psychosis 31.52 26.30 18 24400 2131 42594786
Salivary hypersecretion 31.48 26.30 35 24383 10908 42586009
Extra dose administered 31.34 26.30 26 24392 5643 42591274
Psychiatric decompensation 31.23 26.30 23 24395 4199 42592718
Oedema peripheral 30.82 26.30 20 24398 136056 42460861
Drug interaction 30.81 26.30 67 24351 266932 42329985
Cardiac failure congestive 30.47 26.30 6 24412 85596 42511321
Soliloquy 30.43 26.30 12 24406 617 42596300
Rhabdomyolysis 30.31 26.30 106 24312 77913 42519004
Abdominal distension 30.28 26.30 3 24415 71732 42525185
Decreased appetite 30.05 26.30 40 24378 193097 42403820
Hyperkalaemia 30.02 26.30 5 24413 80453 42516464
Sudden death 29.86 26.30 42 24376 16587 42580330
Device malfunction 29.72 26.30 36 24382 12291 42584626
Substance use 29.32 26.30 16 24402 1735 42595182
Back pain 29.27 26.30 23 24395 141753 42455164
Hypoxia 29.24 26.30 3 24415 69783 42527134
Libido disorder 28.94 26.30 10 24408 353 42596564
Product outer packaging issue 28.39 26.30 5 24413 6 42596911
Drug abuse 28.30 26.30 127 24291 104644 42492273
Loss of libido 27.98 26.30 19 24399 3051 42593866
Urinary tract infection 27.85 26.30 11 24407 99273 42497644
Injection site abscess 27.77 26.30 13 24405 1019 42595898
Nasopharyngitis 27.66 26.30 7 24411 83989 42512928
Anger 26.59 26.30 35 24383 12983 42583934
Blood creatine phosphokinase increased 26.47 26.30 74 24344 48264 42548653

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
Blood prolactin increased 1220.79 25.81 274 27875 4368 110556782
Product dose omission issue 1165.43 25.81 822 27327 320960 110240190
Hospitalisation 1030.44 25.81 566 27583 141927 110419223
Galactorrhoea 887.09 25.81 207 27942 3948 110557202
Inappropriate schedule of product administration 846.04 25.81 567 27582 203070 110358080
Psychotic disorder 792.10 25.81 342 27807 50595 110510555
Treatment noncompliance 772.69 25.81 375 27774 72615 110488535
Blood prolactin abnormal 682.92 25.81 165 27984 3670 110557480
Disturbance in social behaviour 666.82 25.81 171 27978 4887 110556263
Sexual dysfunction 662.43 25.81 190 27959 8340 110552810
Hallucination, auditory 661.90 25.81 250 27899 26147 110535003
Dystonia 649.24 25.81 245 27904 25560 110535590
Extrapyramidal disorder 636.63 25.81 249 27900 28618 110532532
Anosognosia 627.58 25.81 156 27993 3918 110557232
Injection site nodule 621.92 25.81 159 27990 4487 110556663
Akathisia 574.23 25.81 201 27948 16912 110544238
Off label use 524.07 25.81 1162 26987 1499023 109062127
Incorrect dose administered 506.54 25.81 320 27829 103321 110457829
Metabolic disorder 477.30 25.81 155 27994 10355 110550795
Dyskinesia 466.21 25.81 238 27911 51208 110509942
Sedation 454.20 25.81 259 27890 69424 110491726
Amenorrhoea 443.12 25.81 142 28007 9089 110552061
Personality change 434.43 25.81 146 28003 10856 110550294
Gynaecomastia 406.86 25.81 134 28015 9356 110551794
Syringe issue 390.36 25.81 130 28019 9395 110551755
Hyperprolactinaemia 386.09 25.81 118 28031 6457 110554693
Suicide attempt 383.65 25.81 269 27880 103125 110458025
Delusion 367.30 25.81 159 27990 23596 110537554
Aggression 358.96 25.81 210 27939 59000 110502150
Psychotic symptom 349.43 25.81 97 28052 3770 110557380
Paranoia 314.30 25.81 140 28009 22234 110538916
Tardive dyskinesia 312.93 25.81 121 28028 13458 110547692
Neuroleptic malignant syndrome 289.51 25.81 151 27998 33908 110527242
Abnormal behaviour 272.90 25.81 152 27997 38887 110522263
Refusal of treatment by patient 271.15 25.81 99 28050 9395 110551755
Weight increased 235.17 25.81 399 27750 419245 110141905
Injection site mass 208.80 25.81 109 28040 24504 110536646
Underdose 196.10 25.81 148 28001 63406 110497744
Suicidal ideation 193.67 25.81 173 27976 93764 110467386
Drooling 187.49 25.81 70 28079 7069 110554081
Parkinsonism 167.73 25.81 91 28058 22096 110539054
Blood glucose increased 165.73 25.81 186 27963 132310 110428840
Product administered at inappropriate site 164.32 25.81 59 28090 5334 110555816
Injection site pain 162.57 25.81 213 27936 177709 110383441
Needle issue 157.03 25.81 81 28068 17759 110543391
Schizophrenia 152.54 25.81 85 28064 21741 110539409
Diarrhoea 146.27 25.81 54 28095 1139451 109421699
Therapeutic response decreased 139.05 25.81 146 28003 96353 110464797
Hallucination 136.51 25.81 148 28001 101284 110459866
Device leakage 135.90 25.81 71 28078 15977 110545173
Product leakage 134.38 25.81 38 28111 1580 110559570
Erectile dysfunction 128.95 25.81 72 28077 18484 110542666
Nausea 128.77 25.81 78 28071 1235612 109325538
Arthralgia 126.43 25.81 23 28126 779609 109781541
Catatonia 122.17 25.81 59 28090 11241 110549909
Tremor 119.25 25.81 197 27952 202035 110359115
Drug ineffective 107.25 25.81 706 27443 1519834 109041316
Psychiatric symptom 105.37 25.81 50 28099 9163 110551987
Breast discharge 105.31 25.81 28 28121 922 110560228
Mania 98.38 25.81 63 28086 20733 110540417
Joint swelling 89.32 25.81 6 28143 442839 110118311
Muscle rigidity 87.77 25.81 62 28087 23969 110537181
Pain 87.73 25.81 69 28080 954886 109606264
Injection site abscess 84.65 25.81 28 28121 1978 110559172
Abdominal pain 83.35 25.81 15 28134 512974 110048176
Sudden death 82.36 25.81 60 28089 24335 110536815
Product use in unapproved indication 81.80 25.81 275 27874 447102 110114048
Rhabdomyolysis 81.53 25.81 125 28024 120276 110440874
Insurance issue 81.51 25.81 44 28105 10568 110550582
Drug hypersensitivity 78.90 25.81 11 28138 454079 110107071
Abdominal discomfort 77.51 25.81 6 28143 393852 110167298
Agitation 76.02 25.81 117 28032 112934 110448216
Product administration error 75.57 25.81 68 28081 37149 110524001
Accidental exposure to product 74.40 25.81 77 28072 49931 110511219
Irritability 73.63 25.81 75 28074 47734 110513416
Dyspnoea 72.67 25.81 106 28043 1106766 109454384
Mental impairment 72.64 25.81 54 28095 22585 110538565
Mental disorder 69.32 25.81 66 28083 38725 110522425
Rash 67.26 25.81 66 28083 820898 109740252
Pruritus 67.26 25.81 32 28117 581528 109979622
Product use issue 66.39 25.81 202 27947 311493 110249657
Salivary hypersecretion 66.07 25.81 46 28103 17375 110543775
Depression 66.05 25.81 204 27945 317131 110244019
Fatigue 65.58 25.81 132 28017 1215826 109345324
Nasopharyngitis 65.20 25.81 11 28138 394350 110166800
Retrograde ejaculation 64.59 25.81 16 28133 395 110560755
Cough 64.06 25.81 19 28130 461622 110099528
Vomiting 62.93 25.81 84 28065 910591 109650559
Psychiatric decompensation 62.01 25.81 30 28119 5735 110555415
Drug intolerance 61.61 25.81 14 28135 406498 110154652
Social avoidant behaviour 60.97 25.81 29 28120 5340 110555810
Acute kidney injury 60.71 25.81 44 28105 635386 109925764
Anaemia 60.40 25.81 32 28117 547054 110014096
Oculogyric crisis 60.35 25.81 26 28123 3806 110557344
Restlessness 60.28 25.81 73 28076 56186 110504964
Intentional self-injury 59.99 25.81 60 28089 37369 110523781
Thinking abnormal 59.82 25.81 41 28108 15099 110546051
Blood creatine phosphokinase increased 59.81 25.81 83 28066 72994 110488156
Pulmonary embolism 59.44 25.81 153 27996 214321 110346829
Abdominal pain upper 59.37 25.81 9 28140 349102 110212048
Anxiety 58.54 25.81 207 27942 344871 110216279
Personality change due to a general medical condition 58.36 25.81 14 28135 301 110560849
Breast enlargement 57.24 25.81 20 28129 1669 110559481
Infection 55.84 25.81 12 28137 362188 110198962
Wrong technique in product usage process 55.38 25.81 88 28061 87260 110473890
Imprisonment 54.86 25.81 16 28133 743 110560407
Adverse drug reaction 54.48 25.81 97 28052 105462 110455688
Injection site reaction 54.10 25.81 88 28061 88982 110472168
Swelling 53.37 25.81 12 28137 351029 110210121
Pyrexia 53.22 25.81 92 28057 898173 109662977
Injection site induration 52.64 25.81 34 28115 11349 110549801
Headache 52.62 25.81 90 28059 882287 109678863
Alopecia 52.47 25.81 14 28135 364739 110196411
Eye movement disorder 52.38 25.81 32 28117 9696 110551454
Substance abuse 52.22 25.81 35 28114 12428 110548722
Blunted affect 50.72 25.81 14 28135 532 110560618
Completed suicide 49.64 25.81 155 27994 242226 110318924
Breast tenderness 48.54 25.81 20 28129 2620 110558530
Persecutory delusion 48.08 25.81 26 28123 6265 110554885
Wound 47.76 25.81 3 28146 234434 110326716
Disease progression 47.21 25.81 4 28145 244030 110317120
Lower respiratory tract infection 46.98 25.81 4 28145 243102 110318048
Drug abuse 44.51 25.81 122 28027 177289 110383861
Injection site swelling 44.43 25.81 66 28083 61724 110499426
Hypertension 44.08 25.81 39 28110 510045 110051105
Sepsis 42.69 25.81 15 28134 327331 110233819
Urticaria 42.64 25.81 14 28135 318843 110242307
Condition aggravated 42.50 25.81 326 27823 734510 109826640
Soliloquy 42.00 25.81 14 28135 1013 110560137
Priapism 41.42 25.81 23 28126 5838 110555312
Asthma 41.31 25.81 7 28142 250284 110310866
Peripheral swelling 41.19 25.81 26 28123 404008 110157142
Asthenia 39.47 25.81 72 28077 688927 109872223
Flat affect 39.46 25.81 17 28132 2488 110558662
Psychosexual disorder 39.24 25.81 9 28140 158 110560992
Pericarditis 38.76 25.81 5 28144 219109 110342041
Apathy 37.64 25.81 32 28117 16207 110544943
Tobacco user 37.45 25.81 12 28137 766 110560384
Dyspepsia 37.29 25.81 3 28146 190962 110370188
Extra dose administered 36.77 25.81 28 28121 12131 110549019
Homicidal ideation 36.39 25.81 18 28131 3609 110557541
Poor personal hygiene 35.86 25.81 11 28138 608 110560542
Device malfunction 35.59 25.81 38 28111 25520 110535630
Back pain 34.98 25.81 26 28123 370970 110190180
Wrong product administered 34.84 25.81 26 28123 10934 110550216
Lung disorder 34.68 25.81 3 28146 180044 110381106
Incorrect route of product administration 34.51 25.81 60 28089 64001 110497149
Maternal exposure during pregnancy 34.41 25.81 11 28138 254872 110306278
Prolactin-producing pituitary tumour 34.29 25.81 8 28141 152 110560998
Blister 34.09 25.81 8 28141 227368 110333782
Investigation 34.04 25.81 15 28134 2317 110558833
Emotional disorder 33.73 25.81 30 28119 16130 110545020
Abnormal weight gain 33.61 25.81 17 28132 3574 110557576
Pain in extremity 33.49 25.81 45 28104 487073 110074077
Contraindicated product administered 33.01 25.81 11 28138 248256 110312894
Schizoaffective disorder 32.77 25.81 16 28133 3120 110558030
Treatment failure 32.39 25.81 15 28134 277219 110283931
Ejaculation disorder 32.24 25.81 10 28139 574 110560576
Physical assault 32.21 25.81 13 28136 1615 110559535
Neuropathy peripheral 31.93 25.81 4 28145 179273 110381877
Arthritis 31.72 25.81 3 28146 167583 110393567
Ejaculation failure 31.71 25.81 9 28140 379 110560771
Hypersensitivity 31.29 25.81 34 28115 403964 110157186
Gastrointestinal haemorrhage 31.23 25.81 3 28146 165515 110395635
Terminal dribbling 30.27 25.81 5 28144 12 110561138
Injection site infection 29.43 25.81 14 28135 2579 110558571
Mobility decreased 29.08 25.81 12 28137 237410 110323740
Menstruation irregular 28.51 25.81 18 28131 5779 110555371
Polydipsia 28.45 25.81 20 28129 7668 110553482
Psychomotor hyperactivity 27.97 25.81 30 28119 20247 110540903
Hypothermia 27.96 25.81 34 28115 26268 110534882
Decreased appetite 27.87 25.81 49 28100 475797 110085353
Toxicity to various agents 27.68 25.81 50 28099 480505 110080645
Insomnia 27.30 25.81 171 27978 360419 110200731
Saccadic eye movement 27.18 25.81 7 28142 203 110560947
Hepatic enzyme increased 27.14 25.81 25 28124 320867 110240283
Inappropriate antidiuretic hormone secretion 27.02 25.81 38 28111 33813 110527337
Pleurothotonus 26.87 25.81 13 28136 2485 110558665
Bronchitis 26.79 25.81 4 28145 157028 110404122
Haemoglobin decreased 26.75 25.81 15 28134 248712 110312438
Musculoskeletal pain 26.35 25.81 7 28142 183016 110378134
Enteritis necroticans 26.33 25.81 4 28145 4 110561146
Product outer packaging issue 26.12 25.81 5 28144 34 110561116

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA EPC N0000175430 Atypical Antipsychotic
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014150 Antipsychotic Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018490 Serotonin Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D065127 Dopamine D2 Receptor Antagonists
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35471 psychotropic drug
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:37890 α-adrenergic antagonist
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:49103 drug metabolite
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:65191 second generation antipsychotic

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

DiseaseRelationSNOMED_IDDOID
Schizophrenia indication 58214004 DOID:5419
Priapism contraindication 6273006 DOID:9286
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Agranulocytosis contraindication 17182001 DOID:12987
Lowered convulsive threshold contraindication 19260006
Myocardial infarction contraindication 22298006 DOID:5844
Stenosis of intestine contraindication 23065003
Short bowel syndrome contraindication 26629001 DOID:10605
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Parkinsonism contraindication 32798002
Crohn's disease contraindication 34000006
Dehydration contraindication 34095006
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Hyperlipidemia contraindication 55822004 DOID:1168
Cerebrovascular disease contraindication 62914000 DOID:6713
Substance abuse contraindication 66214007
Diabetes mellitus contraindication 73211009 DOID:9351
Extrapyramidal disease contraindication 76349003
Diffuse Lewy body disease contraindication 80098002
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Tardive dyskinesia contraindication 102449007
Increased intestinal motility contraindication 102624003
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Impaired renal function disorder contraindication 197663003
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Esophageal dysmotility contraindication 266434009 DOID:9192
Neutropenic disorder contraindication 303011007 DOID:1227
At risk for aspiration contraindication 371736008
Impaired cognition contraindication 386806002
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Gastrointestinal hypomotility contraindication 421807004
Acquired torsion dystonia contraindication 433493000
Congenital long QT syndrome contraindication 442917000
Carcinoma of female breast contraindication 447782002
Esophageal Compression contraindication
Intestinal Cystic Fibrosis contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.78 Basic
pKa2 1.52 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
273MG/0.875ML (273MG/0.875ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
273MG/0.875ML (273MG/0.875ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
410MG/1.315ML (311.79MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
410MG/1.315ML (311.79MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
546MG/1.75ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
546MG/1.75ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
819MG/2.625ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
819MG/2.625ML (312MG/ML) INVEGA TRINZA JANSSEN PHARMS N207946 May 18, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10143693 April 5, 2036 REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
117MG/0.75ML (117MG/0.75ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
117MG/0.75ML (117MG/0.75ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
156MG/ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
156MG/ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
234MG/1.5ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
234MG/1.5ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
351MG/2.25ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
351MG/2.25ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
39MG/0.25ML (39MG/0.25ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
39MG/0.25ML (39MG/0.25ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
78MG/0.5ML (78MG/0.5ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
78MG/0.5ML (78MG/0.5ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12128049 Oct. 26, 2038 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
117MG/0.75ML (117MG/0.75ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
117MG/0.75ML (117MG/0.75ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
156MG/ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
156MG/ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
234MG/1.5ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
234MG/1.5ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
351MG/2.25ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
351MG/2.25ML (156MG/ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
39MG/0.25ML (39MG/0.25ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
39MG/0.25ML (39MG/0.25ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
78MG/0.5ML (78MG/0.5ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
78MG/0.5ML (78MG/0.5ML) ERZOFRI LUYE INNOMIND PHARMA N216352 July 26, 2024 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666573 Sept. 24, 2039 DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S)
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11304951 May 7, 2041 REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11324751 May 7, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12208100 May 7, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12208100 May 7, 2041 TREATMENT OF SCHIZOPHRENIA IN A PATIENT PREVIOUSLY BEEN TREATED WITH ONCE-A-MONTH (PP1M) OR ONCE-EVERY-THREE-MONTHS (PP3M) PALIPERIDONE PALMITATE BY SWITCHING TO ONCE-EVERY-SIX-MONTH PALIPERIDONE PALMITATE USING A DOSING WINDOW OF A DOSING REGIMEN
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11304951 May 7, 2041 REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11324751 May 7, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12208100 May 7, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 12208100 May 7, 2041 TREATMENT OF SCHIZOPHRENIA IN A PATIENT PREVIOUSLY BEEN TREATED WITH ONCE-A-MONTH (PP1M) OR ONCE-EVERY-THREE-MONTHS (PP3M) PALIPERIDONE PALMITATE BY SWITCHING TO ONCE-EVERY-SIX-MONTH PALIPERIDONE PALMITATE USING A DOSING WINDOW OF A DOSING REGIMEN
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666697 Nov. 24, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11666697 Nov. 24, 2041 TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST DRUG LABEL DRUG LABEL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.89 CHEMBL

External reference:

IDSource
D05340 KEGG_DRUG
4029217 VUID
N0000181687 NUI
4025875 VANDF
4029217 VANDF
CHEMBL2107360 ChEMBL_ID
R8P8USM8FR UNII
679314 RXNORM
166838 MMSL
23004 MMSL
26654 MMSL
d06297 MMSL
011888 NDDF
013207 NDDF
425483000 SNOMEDCT_US
426276000 SNOMEDCT_US
706896003 SNOMEDCT_US
C2719626 UMLSCUI
D000068882 MESH_DESCRIPTOR_UI
C0753678 UMLSCUI
CHEBI:83807 CHEBI
DB01267 DRUGBANK_ID
9852746 PUBCHEM_CID
115237 PUBCHEM_CID
7977 INN_ID
CHEBI:82978 CHEBI
R8P8USM8FR INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-560 INJECTION 39 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-561 INJECTION 78 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-562 INJECTION 117 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-563 INJECTION 156 mg INTRAMUSCULAR NDA 35 sections
INVEGA SUSTENNA HUMAN PRESCRIPTION DRUG LABEL 1 50458-564 INJECTION 234 mg INTRAMUSCULAR NDA 35 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-606 INJECTION, SUSPENSION, EXTENDED RELEASE 273 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-607 INJECTION, SUSPENSION, EXTENDED RELEASE 410 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-608 INJECTION, SUSPENSION, EXTENDED RELEASE 546 mg INTRAMUSCULAR NDA 40 sections
INVEGA TRINZA HUMAN PRESCRIPTION DRUG LABEL 1 50458-609 INJECTION, SUSPENSION, EXTENDED RELEASE 819 mg INTRAMUSCULAR NDA 40 sections
INVEGA HAFYERA HUMAN PRESCRIPTION DRUG LABEL 1 50458-611 INJECTION, SUSPENSION, EXTENDED RELEASE 1092 mg INTRAMUSCULAR NDA 40 sections
INVEGA HAFYERA HUMAN PRESCRIPTION DRUG LABEL 1 50458-612 INJECTION, SUSPENSION, EXTENDED RELEASE 1560 mg INTRAMUSCULAR NDA 40 sections
Erzofri extended-release HUMAN PRESCRIPTION DRUG LABEL 1 72526-105 INJECTION 39 mg INTRAMUSCULAR NDA 34 sections
Erzofri extended-release HUMAN PRESCRIPTION DRUG LABEL 1 72526-106 INJECTION 78 mg INTRAMUSCULAR NDA 34 sections
Erzofri extended-release HUMAN PRESCRIPTION DRUG LABEL 1 72526-107 INJECTION 117 mg INTRAMUSCULAR NDA 34 sections
Erzofri extended-release HUMAN PRESCRIPTION DRUG LABEL 1 72526-108 INJECTION 156 mg INTRAMUSCULAR NDA 34 sections
Erzofri extended-release HUMAN PRESCRIPTION DRUG LABEL 1 72526-109 INJECTION 234 mg INTRAMUSCULAR NDA 34 sections
Erzofri extended-release HUMAN PRESCRIPTION DRUG LABEL 1 72526-110 INJECTION 351 mg INTRAMUSCULAR NDA 34 sections