paliperidone palmitate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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:

None

Approvals:

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

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 1848.84 30.00 363 13234 2736 50588791
Galactorrhoea 1699.80 30.00 349 13248 3374 50588153
Amenorrhoea 943.09 30.00 253 13344 8231 50583296
Injection site nodule 877.78 30.00 199 13398 3149 50588378
Product dose omission issue 575.11 30.00 439 13158 183399 50408128
Blood prolactin abnormal 541.47 30.00 124 13473 2051 50589476
Inappropriate schedule of product administration 534.29 30.00 296 13301 71535 50519992
Psychotic disorder 446.87 30.00 181 13416 21631 50569896
Disturbance in social behaviour 421.10 30.00 107 13490 2787 50588740
Anosognosia 376.92 30.00 93 13504 2141 50589386
Hospitalisation 372.67 30.00 230 13367 67707 50523820
Sexual dysfunction 359.88 30.00 97 13500 3195 50588332
Hyperprolactinaemia 357.77 30.00 97 13500 3268 50588259
Off label use 347.21 30.00 522 13075 473904 50117623
Hallucination, auditory 342.10 30.00 123 13474 10605 50580922
Dystonia 329.40 30.00 123 13474 11803 50579724
Metabolic disorder 306.03 30.00 95 13502 5191 50586336
Extrapyramidal disorder 298.29 30.00 114 13483 11656 50579871
Injection site mass 293.36 30.00 122 13475 15558 50575969
Personality change 291.62 30.00 93 13504 5552 50585975
Sedation 288.68 30.00 148 13449 30462 50561065
Weight increased 281.75 30.00 307 13290 201584 50389943
Akathisia 276.12 30.00 98 13499 8131 50583396
Incorrect dose administered 270.58 30.00 166 13431 48248 50543279
Breast discharge 252.66 30.00 56 13541 791 50590736
Dyskinesia 251.99 30.00 131 13466 27730 50563797
Treatment noncompliance 233.92 30.00 128 13469 30022 50561505
Syringe issue 201.00 30.00 56 13541 2088 50589439
Suicide attempt 195.54 30.00 139 13458 51593 50539934
Psychotic symptom 187.09 30.00 47 13550 1165 50590362
Tardive dyskinesia 175.43 30.00 68 13529 7211 50584316
Product use in unapproved indication 174.97 30.00 184 13413 115635 50475892
Delusion 170.29 30.00 74 13523 10495 50581032
Refusal of treatment by patient 168.80 30.00 60 13537 4993 50586534
Injection site pain 163.45 30.00 174 13423 110850 50480677
Paranoia 162.00 30.00 71 13526 10277 50581250
Device leakage 131.37 30.00 52 13545 5826 50585701
Therapeutic response decreased 121.48 30.00 101 13496 47130 50544397
Blood glucose increased 116.01 30.00 118 13479 71206 50520321
Underdose 111.77 30.00 69 13528 20209 50571318
Diarrhoea 106.21 30.00 16 13581 588460 50003067
Product administered at inappropriate site 104.87 30.00 35 13562 2408 50589119
Aggression 104.23 30.00 67 13530 21049 50570478
Nausea 101.53 30.00 32 13565 705366 49886161
Insurance issue 84.12 30.00 30 13567 2518 50589009
Drooling 79.35 30.00 31 13566 3353 50588174
Product quality issue 79.33 30.00 66 13531 30792 50560735
Injection site abscess 78.54 30.00 23 13574 1026 50590501
Pain 78.43 30.00 29 13568 578874 50012653
Arthralgia 76.62 30.00 13 13584 438689 50152838
Condition aggravated 74.58 30.00 211 13386 296847 50294680
Injection site reaction 70.98 30.00 77 13520 49955 50541572
Injection site swelling 69.48 30.00 70 13527 41703 50549824
Abnormal behaviour 65.50 30.00 49 13548 19609 50571918
Accidental exposure to product 62.78 30.00 51 13546 23006 50568521
Breast enlargement 59.65 30.00 20 13577 1395 50590132
Parkinsonism 58.87 30.00 34 13563 8813 50582714
Fatigue 58.14 30.00 63 13534 707538 49883989
Hallucination 57.94 30.00 67 13530 46590 50544937
Drug ineffective 55.43 30.00 392 13205 818941 49772586
Injection site induration 55.16 30.00 32 13565 8365 50583162
Suicidal ideation 54.94 30.00 71 13526 55314 50536213
Cough 52.75 30.00 3 13594 241261 50350266
Headache 52.60 30.00 36 13561 506499 50085028
Imprisonment 52.10 30.00 12 13585 203 50591324
Lactation disorder 51.78 30.00 13 13584 321 50591206
Product use issue 51.75 30.00 120 13477 149355 50442172
Neuroleptic malignant syndrome 51.68 30.00 34 13563 11096 50580431
Dyspnoea 51.64 30.00 43 13554 547565 50043962
Abdominal discomfort 50.27 30.00 3 13594 231638 50359889
Needle issue 48.52 30.00 28 13569 7247 50584280
Joint swelling 48.15 30.00 5 13592 245281 50346246
Drug hypersensitivity 47.07 30.00 6 13591 251004 50340523
Adverse event 46.40 30.00 58 13539 43705 50547822
Schizophrenia 45.45 30.00 27 13570 7370 50584157
Breast tenderness 45.00 30.00 18 13579 2070 50589457
Menstruation irregular 44.54 30.00 25 13572 6137 50585390
Product administration error 44.23 30.00 39 13558 19660 50571867
Tremor 43.94 30.00 96 13501 114807 50476720
Vomiting 43.62 30.00 36 13561 460722 50130805
Prolactin-producing pituitary tumour 43.27 30.00 9 13588 92 50591435
Anaemia 42.86 30.00 8 13589 252448 50339079
Drug intolerance 41.65 30.00 5 13592 219099 50372428
Wrong technique in product usage process 41.33 30.00 62 13535 55448 50536079
Abdominal pain 41.16 30.00 7 13590 236221 50355306
Abnormal weight gain 40.14 30.00 15 13582 1437 50590090
Social avoidant behaviour 39.93 30.00 18 13579 2779 50588748
Pneumonia 39.08 30.00 27 13570 378374 50213153
Mania 38.13 30.00 28 13569 10888 50580639
Catatonia 37.89 30.00 19 13578 3717 50587810
Nasopharyngitis 37.67 30.00 4 13593 192923 50398604
Product leakage 36.92 30.00 11 13586 521 50591006
Blunted affect 35.97 30.00 9 13588 219 50591308
Pruritus 35.36 30.00 16 13581 283552 50307975
Back pain 35.22 30.00 8 13589 220022 50371505
Psychiatric decompensation 34.79 30.00 13 13584 1245 50590282
Pyrexia 34.38 30.00 31 13566 380172 50211355
Pituitary tumour benign 33.75 30.00 14 13583 1767 50589760
Breast engorgement 31.97 30.00 7 13590 93 50591434
Adverse drug reaction 31.96 30.00 55 13542 55167 50536360
Acute kidney injury 31.48 30.00 11 13586 228047 50363480
Peripheral swelling 30.07 30.00 9 13588 205927 50385600
Asthenia 30.05 30.00 25 13572 319017 50272510

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 1297.66 27.24 774 17182 95609 29460962
Inappropriate schedule of product administration 1084.94 27.24 531 17425 43941 29512630
Psychotic disorder 799.02 27.24 339 17617 20015 29536556
Blood prolactin increased 654.75 27.24 158 17798 1376 29555195
Hospitalisation 654.04 27.24 384 17572 45604 29510967
Off label use 499.80 27.24 749 17207 300051 29256520
Treatment noncompliance 454.68 27.24 243 17713 23984 29532587
Hallucination, auditory 433.94 27.24 177 17779 9416 29547155
Incorrect dose administered 430.77 27.24 261 17695 32723 29523848
Injection site nodule 430.45 27.24 112 17844 1358 29555213
Akathisia 402.11 27.24 152 17804 6590 29549981
Gynaecomastia 397.06 27.24 159 17797 8058 29548513
Extrapyramidal disorder 354.72 27.24 159 17797 10672 29545899
Weight increased 307.34 27.24 300 17656 76367 29480204
Therapeutic response decreased 300.60 27.24 187 17769 24524 29532047
Paranoia 288.74 27.24 134 17822 9743 29546828
Syringe issue 272.52 27.24 98 17858 3680 29552891
Sexual dysfunction 261.86 27.24 107 17849 5707 29550864
Delusion 257.68 27.24 129 17827 11087 29545484
Refusal of treatment by patient 237.71 27.24 94 17862 4600 29551971
Psychotic symptom 230.29 27.24 68 17888 1346 29555225
Drug ineffective 225.22 27.24 600 17356 362570 29194001
Therapeutic product effect decreased 224.62 27.24 167 17789 29284 29527287
Dystonia 223.55 27.24 112 17844 9637 29546934
Blood prolactin abnormal 215.81 27.24 58 17898 802 29555769
Sedation 209.76 27.24 131 17825 17274 29539297
Aggression 205.17 27.24 171 17785 35370 29521201
Underdose 189.16 27.24 107 17849 11762 29544809
Tardive dyskinesia 168.26 27.24 76 17880 5182 29551389
Anosognosia 162.87 27.24 46 17910 772 29555799
Injection site pain 158.60 27.24 142 17814 32304 29524267
Disturbance in social behaviour 156.80 27.24 53 17903 1649 29554922
Dyskinesia 144.52 27.24 110 17846 19951 29536620
Suicidal ideation 140.89 27.24 137 17819 34579 29521992
Galactorrhoea 139.77 27.24 35 17921 359 29556212
Erectile dysfunction 134.71 27.24 101 17855 17908 29538663
Neuroleptic malignant syndrome 133.04 27.24 96 17860 16052 29540519
Product administered at inappropriate site 125.45 27.24 45 17911 1675 29554896
Device leakage 125.16 27.24 59 17897 4436 29552135
Injection site mass 123.04 27.24 62 17894 5393 29551178
Condition aggravated 121.05 27.24 271 17685 146024 29410547
Product leakage 113.10 27.24 30 17926 393 29556178
Schizophrenia 112.23 27.24 62 17894 6503 29550068
Abnormal behaviour 110.56 27.24 100 17856 23027 29533544
Breast enlargement 110.54 27.24 30 17926 431 29556140
Diarrhoea 110.01 27.24 33 17923 332665 29223906
Suicide attempt 104.83 27.24 116 17840 33994 29522577
Product quality issue 103.25 27.24 82 17874 15813 29540758
Adverse event 101.72 27.24 80 17876 15211 29541360
Psychosexual disorder 101.22 27.24 21 17935 82 29556489
Drooling 97.70 27.24 44 17912 2977 29553594
Product administration error 97.64 27.24 76 17880 14234 29542337
Needle issue 90.56 27.24 48 17908 4635 29551936
Hallucination 90.25 27.24 123 17833 44589 29511982
Product use issue 89.77 27.24 132 17824 51312 29505259
Hyperprolactinaemia 88.02 27.24 32 17924 1238 29555333
Mania 86.56 27.24 58 17898 8605 29547966
Acute kidney injury 86.34 27.24 27 17929 265240 29291331
Metabolic disorder 86.28 27.24 43 17913 3652 29552919
Imprisonment 86.10 27.24 25 17931 465 29556106
Accidental exposure to product 84.17 27.24 62 17894 10691 29545880
Parkinsonism 83.16 27.24 53 17903 7225 29549346
Anaemia 80.23 27.24 13 17943 200938 29355633
Product use in unapproved indication 79.74 27.24 168 17788 86707 29469864
Psychiatric symptom 77.15 27.24 38 17918 3146 29553425
Pneumonia 74.39 27.24 52 17904 320120 29236451
Sepsis 70.52 27.24 4 17952 142678 29413893
Catatonia 70.39 27.24 40 17916 4428 29552143
Injection site reaction 68.99 27.24 56 17900 11132 29545439
Personality change 66.36 27.24 39 17917 4599 29551972
Wrong technique in product usage process 64.21 27.24 87 17869 31341 29525230
Agitation 63.95 27.24 113 17843 51191 29505380
Eye movement disorder 63.42 27.24 35 17921 3661 29552910
Retrograde ejaculation 63.39 27.24 18 17938 308 29556263
Dyspnoea 61.35 27.24 65 17891 326667 29229904
Social avoidant behaviour 59.28 27.24 31 17925 2911 29553660
Abdominal pain 58.10 27.24 7 17949 135350 29421221
Nausea 57.17 27.24 55 17901 289200 29267371
Breast tenderness 56.91 27.24 20 17936 700 29555871
Anxiety 55.22 27.24 144 17812 85221 29471350
Flat affect 55.05 27.24 20 17936 772 29555799
Priapism 54.57 27.24 34 17922 4454 29552117
Incorrect route of product administration 54.15 27.24 48 17908 10753 29545818
Toxicity to various agents 52.39 27.24 20 17936 173641 29382930
Pyrexia 51.98 27.24 59 17897 287563 29269008
Muscle rigidity 45.55 27.24 41 17915 9370 29547201
Haemoglobin decreased 45.53 27.24 6 17950 108369 29448202
Cough 44.67 27.24 11 17945 126716 29429855
Breast discharge 44.49 27.24 9 17947 30 29556541
Fatigue 43.42 27.24 79 17877 316742 29239829
Product packaging issue 42.49 27.24 15 17941 532 29556039
Wrong product administered 42.08 27.24 29 17927 4502 29552069
Intentional self-injury 41.07 27.24 44 17912 12417 29544154
Mental impairment 40.68 27.24 38 17918 9103 29547468
Arthralgia 40.58 27.24 17 17939 139600 29416971
Thinking abnormal 40.54 27.24 30 17926 5206 29551365
Restlessness 40.29 27.24 58 17898 22087 29534484
Asthenia 40.10 27.24 43 17913 215207 29341364
Investigation 39.22 27.24 16 17940 848 29555723
Irritability 38.82 27.24 57 17899 22095 29534476
Device malfunction 37.16 27.24 35 17921 8472 29548099
Renal failure 36.85 27.24 13 17943 118586 29437985
Rash 36.38 27.24 37 17919 189782 29366789
Medication error 36.33 27.24 54 17902 21157 29535414
Pruritus 35.98 27.24 13 17943 116836 29439735
Cardiac failure congestive 35.33 27.24 3 17953 76578 29479993
Blood creatinine increased 35.05 27.24 5 17951 85097 29471474
Atrial fibrillation 33.83 27.24 11 17945 105635 29450936
Hypotension 32.78 27.24 42 17914 194312 29362259
Extra dose administered 31.69 27.24 21 17935 3056 29553515
Adverse drug reaction 31.32 27.24 54 17902 23966 29532605
Respiratory failure 31.30 27.24 10 17946 97121 29459450
Ejaculation failure 30.75 27.24 13 17943 754 29555817
Psychiatric decompensation 30.74 27.24 16 17940 1488 29555083
Decreased appetite 30.58 27.24 26 17930 145316 29411255
Infection 30.49 27.24 5 17951 76746 29479825
Tremor 29.54 27.24 105 17851 73433 29483138
Drug interaction 29.00 27.24 47 17909 197338 29359233
Injection site rash 28.90 27.24 21 17935 3543 29553028
Injection site abscess 28.37 27.24 12 17944 697 29555874
Vomiting 28.06 27.24 54 17902 212206 29344365
Persecutory delusion 28.01 27.24 17 17939 2124 29554447
Homicidal ideation 27.88 27.24 18 17938 2506 29554065

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 1080.80 23.77 245 19967 3283 64475237
Inappropriate schedule of product administration 913.79 23.77 484 19728 91802 64386718
Product dose omission issue 791.48 23.77 579 19633 194168 64284352
Galactorrhoea 749.78 23.77 179 20033 3040 64475480
Psychotic disorder 643.18 23.77 280 19932 34298 64444222
Injection site nodule 571.43 23.77 144 20068 3086 64475434
Off label use 565.17 23.77 829 19383 631977 63846543
Blood prolactin abnormal 559.63 23.77 137 20075 2595 64475925
Disturbance in social behaviour 530.66 23.77 141 20071 3746 64474774
Sexual dysfunction 515.42 23.77 154 20058 6317 64472203
Anosognosia 510.85 23.77 128 20084 2677 64475843
Extrapyramidal disorder 486.77 23.77 195 20017 19357 64459163
Hospitalisation 483.53 23.77 298 19914 74909 64403611
Dystonia 479.55 23.77 191 20021 18674 64459846
Incorrect dose administered 450.67 23.77 264 19948 60501 64418019
Hallucination, auditory 446.25 23.77 176 20036 16763 64461757
Treatment noncompliance 446.18 23.77 234 19978 43248 64435272
Akathisia 402.13 23.77 147 20065 11363 64467157
Sedation 385.53 23.77 209 20003 41253 64437267
Amenorrhoea 374.88 23.77 121 20091 6418 64472102
Metabolic disorder 371.27 23.77 125 20087 7572 64470948
Dyskinesia 361.90 23.77 197 20015 39191 64439329
Personality change 346.29 23.77 122 20090 8471 64470049
Suicide attempt 316.53 23.77 224 19988 70783 64407737
Syringe issue 285.77 23.77 89 20123 4197 64474323
Hyperprolactinaemia 277.71 23.77 86 20126 3979 64474541
Gynaecomastia 263.87 23.77 91 20121 5925 64472595
Delusion 252.78 23.77 120 20092 17894 64460626
Weight increased 252.66 23.77 322 19890 213026 64265494
Tardive dyskinesia 240.34 23.77 95 20117 9083 64469437
Paranoia 229.65 23.77 109 20103 16243 64462277
Psychotic symptom 228.57 23.77 64 20148 2074 64476446
Refusal of treatment by patient 206.81 23.77 83 20129 8256 64470264
Aggression 197.01 23.77 142 20070 46090 64432430
Injection site mass 182.81 23.77 95 20117 17175 64461345
Product use in unapproved indication 177.21 23.77 246 19966 176372 64302148
Neuroleptic malignant syndrome 173.01 23.77 104 20108 24892 64453628
Injection site pain 152.31 23.77 181 20031 111227 64367293
Underdose 142.33 23.77 93 20119 25736 64452784
Product administered at inappropriate site 140.08 23.77 48 20164 3062 64475458
Therapeutic response decreased 139.80 23.77 122 20090 52066 64426454
Device leakage 134.38 23.77 61 20151 8205 64470315
Suicidal ideation 132.74 23.77 132 20080 66410 64412110
Diarrhoea 125.17 23.77 36 20176 722668 63755852
Abnormal behaviour 124.62 23.77 95 20117 33527 64444993
Product use issue 119.88 23.77 189 20023 151526 64326994
Parkinsonism 118.48 23.77 67 20145 14306 64464214
Drug ineffective 117.52 23.77 546 19666 839701 63638819
Blood glucose increased 115.71 23.77 148 20064 97925 64380595
Drooling 111.66 23.77 47 20165 5272 64473248
Nausea 108.22 23.77 56 20156 785744 63692776
Schizophrenia 102.84 23.77 56 20156 11112 64467408
Insurance issue 98.30 23.77 36 20176 2790 64475730
Product leakage 95.17 23.77 25 20187 633 64477887
Erectile dysfunction 93.77 23.77 55 20157 12572 64465948
Breast discharge 93.52 23.77 24 20188 553 64477967
Arthralgia 90.62 23.77 15 20197 442245 64036275
Needle issue 89.58 23.77 48 20164 9224 64469296
Catatonia 89.56 23.77 45 20167 7575 64470945
Psychiatric symptom 88.60 23.77 42 20170 6231 64472289
Hallucination 82.92 23.77 108 20104 72680 64405840
Accidental exposure to product 73.32 23.77 63 20149 26301 64452219
Dyspnoea 70.55 23.77 73 20139 718601 63759919
Injection site abscess 68.55 23.77 23 20189 1375 64477145
Abdominal pain 67.61 23.77 9 20203 312366 64166154
Pain 66.80 23.77 46 20166 553465 63925055
Sudden death 66.25 23.77 53 20159 20043 64458477
Injection site reaction 65.63 23.77 77 20135 46587 64431933
Anaemia 65.11 23.77 19 20193 378661 64099859
Cough 62.38 23.77 10 20202 302138 64176382
Mania 60.29 23.77 46 20166 16240 64462280
Condition aggravated 59.92 23.77 253 19959 372173 64106347
Tremor 58.92 23.77 138 20074 148092 64330428
Product administration error 57.23 23.77 56 20156 27587 64450933
Fatigue 56.07 23.77 93 20119 748637 63729883
Acute kidney injury 55.96 23.77 36 20176 449204 64029316
Breast enlargement 53.83 23.77 19 20193 1323 64477197
Mental impairment 53.65 23.77 43 20169 16300 64462220
Imprisonment 52.50 23.77 15 20197 523 64477997
Joint swelling 52.29 23.77 4 20208 215378 64263142
Incorrect route of product administration 51.63 23.77 49 20163 23249 64455271
Social avoidant behaviour 50.89 23.77 26 20186 4531 64473989
Eye movement disorder 50.37 23.77 30 20182 7049 64471471
Pruritus 49.57 23.77 18 20194 312382 64166138
Psychiatric decompensation 49.16 23.77 21 20191 2442 64476078
Pulmonary embolism 48.38 23.77 127 20085 146229 64332291
Adverse drug reaction 47.97 23.77 65 20147 45399 64433121
Vomiting 47.49 23.77 62 20150 551055 63927465
Pneumonia 47.16 23.77 64 20148 559512 63919008
Drug hypersensitivity 46.61 23.77 9 20203 237806 64240714
Restlessness 45.23 23.77 59 20153 39726 64438794
Injection site swelling 44.97 23.77 60 20152 41293 64437227
Product quality issue 44.97 23.77 51 20161 29748 64448772
Retrograde ejaculation 44.67 23.77 11 20201 213 64478307
Anxiety 44.36 23.77 152 20060 202497 64276023
Pyrexia 43.05 23.77 68 20144 558576 63919944
Breast tenderness 42.65 23.77 18 20194 2031 64476489
Sepsis 42.51 23.77 10 20202 230331 64248189
Muscle rigidity 41.12 23.77 38 20174 17435 64461085
Abdominal pain upper 40.44 23.77 4 20208 175026 64303494
Psychosexual disorder 40.12 23.77 9 20203 114 64478406
Headache 39.33 23.77 66 20146 529401 63949119
Intentional self-injury 39.30 23.77 47 20165 28997 64449523
Injection site induration 39.30 23.77 28 20184 8904 64469616
Abdominal discomfort 37.68 23.77 6 20206 182316 64296204
Agitation 36.98 23.77 84 20128 88283 64390237
Haemoglobin decreased 36.93 23.77 8 20204 195055 64283465
Adverse event 36.51 23.77 53 20159 39436 64439084
Mental disorder 36.12 23.77 43 20169 26402 64452118
Rash 36.07 23.77 55 20157 458494 64020026
Wrong technique in product usage process 35.63 23.77 69 20143 64905 64413615
Back pain 35.50 23.77 17 20195 250154 64228366
Toxicity to various agents 35.45 23.77 37 20175 363476 64115044
Device malfunction 35.16 23.77 35 20177 17598 64460922
Asthenia 34.97 23.77 50 20162 427994 64050526
Nasopharyngitis 33.35 23.77 10 20202 196063 64282457
Blunted affect 33.25 23.77 10 20202 418 64478102
Drug intolerance 33.06 23.77 9 20203 187983 64290537
Oculogyric crisis 32.83 23.77 16 20196 2522 64475998
Infection 32.24 23.77 9 20203 184871 64293649
Irritability 32.07 23.77 48 20164 36698 64441822
Blood creatine phosphokinase increased 30.67 23.77 61 20151 58497 64420023
Rhabdomyolysis 29.68 23.77 79 20133 91647 64386873
Prolactin-producing pituitary tumour 29.57 23.77 7 20205 114 64478406
Extra dose administered 29.33 23.77 21 20191 6729 64471791
Terminal dribbling 29.23 23.77 5 20207 12 64478508
Investigation 28.54 23.77 14 20198 2238 64476282
Saccadic eye movement 28.21 23.77 7 20205 140 64478380
Urinary tract infection 28.18 23.77 19 20193 231577 64246943
Therapeutic product effect decreased 27.41 23.77 89 20123 115262 64363258
Alopecia 27.20 23.77 9 20203 165681 64312839
Pain in extremity 27.19 23.77 33 20179 303052 64175468
Peripheral swelling 27.04 23.77 16 20196 209137 64269383
Menstruation irregular 26.97 23.77 17 20195 4418 64474102
Depression 26.69 23.77 121 20091 183170 64295350
Renal failure 26.30 23.77 12 20200 181676 64296844
Ejaculation failure 26.18 23.77 8 20204 353 64478167
Soliloquy 26.15 23.77 9 20203 581 64477939
Delirium 25.92 23.77 63 20149 69131 64409389
Cardiac failure congestive 25.44 23.77 5 20207 130575 64347945
Product packaging issue 25.14 23.77 10 20202 970 64477550
Thinking abnormal 25.02 23.77 24 20188 11532 64466988
Flat affect 24.90 23.77 12 20200 1845 64476675
Injection site infection 24.85 23.77 12 20200 1853 64476667
Wrong product administered 24.67 23.77 20 20192 7700 64470820
Libido disorder 24.42 23.77 7 20205 247 64478273
Pleural effusion 24.34 23.77 5 20207 126554 64351966
Tension 24.05 23.77 15 20197 3825 64474695
Neuropathy peripheral 23.98 23.77 4 20208 117521 64360999
Decreased appetite 23.80 23.77 32 20180 281257 64197263

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA EPC N0000175430 Atypical Antipsychotic
MeSH PA D014150 Antipsychotic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D015259 Dopamine Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D065127 Dopamine D2 Receptor Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35471 psychotropic drugs
CHEBI has role CHEBI:37890 alpha-adrenergic receptor blockaders
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:48561 dopaminergic antagonists
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:63726 neuroprotective agents
CHEBI has role CHEBI:65191 atypical antipsychotic agent

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)
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
117MG/0.75ML (117MG/0.75ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
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)
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
156MG/ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
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)
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
234MG/1.5ML (156MG/ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
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)
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
39MG/0.25ML (39MG/0.25ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
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)
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
78MG/0.5ML (78MG/0.5ML) INVEGA SUSTENNA JANSSEN PHARMS N022264 July 31, 2009 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9439906 Jan. 26, 2031 TREATMENT OF SCHIZOPHRENIA
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
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
1.560GM/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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.092GM/3.5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Aug. 30, 2024 NEW STRENGTH
1.560GM/5ML (312MG/ML) INVEGA HAFYERA JANSSEN PHARMS N207946 Aug. 30, 2021 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Aug. 30, 2024 NEW STRENGTH

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
CHEBI:83807 CHEBI
CHEBI:82978 CHEBI
CHEMBL2107360 ChEMBL_ID
R8P8USM8FR UNII
9852746 PUBCHEM_CID
115237 PUBCHEM_CID
DB01267 DRUGBANK_ID
679314 RXNORM
166838 MMSL
23004 MMSL
26654 MMSL
d06297 MMSL
011888 NDDF
013207 NDDF
117004004 SNOMEDCT_US
425483000 SNOMEDCT_US
426276000 SNOMEDCT_US
706896003 SNOMEDCT_US
D000068882 MESH_DESCRIPTOR_UI
C2719626 UMLSCUI
C0753678 UMLSCUI
7977 INN_ID

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 50458-606 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 50458-607 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 50458-608 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 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 38 sections
INVEGA HAFYERA HUMAN PRESCRIPTION DRUG LABEL 1 50458-612 INJECTION, SUSPENSION, EXTENDED RELEASE 1560 mg INTRAMUSCULAR NDA 38 sections