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

Stem definition	Drug id	CAS RN
	4498	199739-10-1

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company	Orphan
July 31, 2009	FDA	JANSSEN PHARMS
Sept. 20, 2013	PMDA	JANSSEN PHARMACEUTICAL K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	7.78	Basic
pKa2	1.52	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	ANTAGONIST			DRUG LABEL	DRUG LABEL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST			DRUG LABEL	DRUG LABEL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.89	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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