pomalidomide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4746	19171-19-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pomalyst actimid pomalidomide	an immunomodulator with antineoplastic and angiogenesis inhibitor activity Molecular weight: 273.25 Formula: C13H11N3O4 CLOGP: -0.19 LIPINSKI: 0 HAC: 7 HDO: 2 TPSA: 109.57 ALOGS: -2.03 ROTB: 1 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pomalyst
actimid
pomalidomide

an immunomodulator with antineoplastic and angiogenesis inhibitor activity

Molecular weight: 273.25
Formula: C13H11N3O4
CLOGP: -0.19
LIPINSKI: 0
HAC: 7
HDO: 2
TPSA: 109.57
ALOGS: -2.03
ROTB: 1

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
3	mg	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Feb. 8, 2013	FDA	CELGENE

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
Plasma cell myeloma	5858.20	20.56	2034	43988	42444	46597596
Death	1322.35	20.56	1632	44390	333916	46306124
Pneumonia	1126.29	20.56	1600	44422	374720	46265320
Full blood count decreased	1091.70	20.56	501	45521	21710	46618330
White blood cell count decreased	847.14	20.56	774	45248	111457	46528583
Neuropathy peripheral	586.11	20.56	575	45447	90318	46549722
Laboratory test abnormal	584.86	20.56	332	45690	22515	46617525
Neutropenia	441.14	20.56	620	45402	142584	46497456
Adverse drug reaction	343.61	20.56	311	45711	44051	46595989
Unevaluable event	308.15	20.56	298	45724	45877	46594163
Thrombosis	283.98	20.56	312	45710	55757	46584283
Platelet count decreased	281.13	20.56	415	45607	99609	46540431
Neutrophil count decreased	279.91	20.56	275	45747	43151	46596889
Fatigue	255.10	20.56	1227	44795	607470	46032570
Plasma cell myeloma recurrent	254.31	20.56	94	45928	2313	46637727
Influenza	234.55	20.56	359	45663	88911	46551129
Rheumatoid arthritis	217.07	20.56	4	46018	240211	46399829
Plasmacytoma	198.17	20.56	79	45943	2398	46637642
Constipation	197.85	20.56	491	45531	173606	46466434
Nasopharyngitis	191.76	20.56	450	45572	153548	46486492
Condition aggravated	182.69	20.56	16	46006	245036	46395004
Human chorionic gonadotropin increased	148.58	20.56	53	45969	1174	46638866
Drug interaction	139.21	20.56	18	46004	203076	46436964
Drug ineffective	127.04	20.56	303	45719	677535	45962505
Bronchitis	112.98	20.56	292	45730	105687	46534353
Infection	112.75	20.56	338	45684	133254	46506786
Drug hypersensitivity	109.14	20.56	52	45970	243773	46396267
Peripheral swelling	98.58	20.56	361	45661	157710	46482330
Full blood count increased	90.65	20.56	34	45988	872	46639168
Muscle spasms	90.50	20.56	297	45725	122816	46517224
Product dose omission issue	88.08	20.56	364	45658	168156	46471884
COVID-19	84.77	20.56	98	45924	18477	46621563
Cytopenia	83.86	20.56	66	45956	7702	46632338
Asthenia	83.39	20.56	558	45464	310517	46329523
Renal disorder	81.03	20.56	115	45907	26571	46613469
Light chain analysis increased	78.03	20.56	32	45990	1046	46638994
Arthralgia	76.21	20.56	153	45869	364450	46275590
Tremor	76.21	20.56	269	45753	115370	46524670
Abdominal pain	75.94	20.56	69	45953	229962	46410078
Cardiac disorder	73.81	20.56	145	45877	43713	46596327
Anaemia	68.58	20.56	459	45563	255320	46384720
Overdose	67.54	20.56	10	46012	101969	46538071
Multiple allergies	65.65	20.56	56	45966	7315	46632725
Vomiting	65.04	20.56	229	45793	452565	46187475
Red blood cell count decreased	62.50	20.56	114	45908	32509	46607531
Headache	62.18	20.56	252	45770	478100	46161940
Psoriasis	61.69	20.56	4	46018	78600	46561440
Hip fracture	58.93	20.56	99	45923	26457	46613583
Urinary tract infection	56.45	20.56	391	45631	219875	46420165
Therapeutic product effect incomplete	55.78	20.56	6	46016	78147	46561893
Blood test abnormal	55.24	20.56	57	45965	9463	46630577
Thrombocytopenia	54.39	20.56	258	45764	126323	46513717
Back pain	53.31	20.56	372	45650	209667	46430373
Product use in unapproved indication	53.01	20.56	12	46010	90261	46549779
Product use issue	52.81	20.56	14	46008	94630	46545410
Plasma cell leukaemia	52.60	20.56	25	45997	1168	46638872
Atrial fibrillation	51.89	20.56	221	45801	103369	46536671
Crystal nephropathy	51.37	20.56	22	46000	803	46639237
Immune system disorder	50.28	20.56	50	45972	7945	46632095
Cataract	48.19	20.56	125	45897	45290	46594750
Sepsis	47.10	20.56	261	45761	135753	46504287
Hyponatraemia	46.21	20.56	21	46001	101311	46538729
Hypercalcaemia	46.08	20.56	78	45944	20968	46619072
Haemoglobin decreased	45.70	20.56	249	45773	128700	46511340
Malaise	45.67	20.56	513	45509	330719	46309321
Rash	44.65	20.56	542	45480	355970	46284070
Seizure	42.88	20.56	35	45987	123019	46517021
Tooth disorder	42.83	20.56	80	45942	23223	46616817
Dizziness	42.82	20.56	518	45504	339896	46300144
Hypokalaemia	42.11	20.56	17	46005	88007	46552033
Wrong technique in product usage process	42.02	20.56	3	46019	54419	46585621
Anxiety	41.77	20.56	72	45950	181885	46458155
Bone pain	41.72	20.56	121	45901	46769	46593271
Respiratory syncytial virus infection	41.57	20.56	36	45986	4799	46635241
Blood count abnormal	41.47	20.56	68	45954	17810	46622230
Renal failure	41.36	20.56	221	45801	113373	46526667
Fall	41.05	20.56	500	45522	328597	46311443
Intentional product use issue	40.50	20.56	3	46019	52777	46587263
Infusion related reaction	40.23	20.56	25	45997	101183	46538857
Drug intolerance	38.19	20.56	262	45760	146787	46493253
Alanine aminotransferase increased	37.79	20.56	20	46002	88431	46551609
Coma	35.80	20.56	7	46015	58342	46581698
Anaphylactic reaction	35.64	20.56	5	46017	53107	46586933
Treatment failure	35.63	20.56	24	45998	93063	46546977
Tachycardia	35.12	20.56	28	45994	99594	46540446
Hospitalisation	34.19	20.56	10	46012	63375	46576665
Deep vein thrombosis	33.80	20.56	162	45860	79611	46560429
Pulmonary thrombosis	33.68	20.56	39	45983	7363	46632677
Respiratory tract infection	33.35	20.56	84	45938	29888	46610152
Aspartate aminotransferase increased	33.32	20.56	18	46004	78682	46561358
Bone lesion	33.17	20.56	32	45990	4899	46635141
Blood calcium increased	32.90	20.56	39	45983	7548	46632492
Pain	32.17	20.56	308	45714	476640	46163400
Electrocardiogram QT prolonged	31.82	20.56	6	46016	51319	46588721
Back disorder	31.67	20.56	42	45980	9099	46630941
Seasonal allergy	31.31	20.56	51	45971	13283	46626757
Monoclonal immunoglobulin present	30.89	20.56	15	46007	735	46639305
Pneumonia influenzal	30.89	20.56	19	46003	1490	46638550
Diarrhoea	29.71	20.56	741	45281	558861	46081179
Cardio-respiratory arrest	29.56	20.56	11	46011	59858	46580182
Agitation	29.42	20.56	9	46013	55406	46584634
Kidney infection	28.83	20.56	56	45966	16733	46623307
Protein total increased	28.68	20.56	22	46000	2471	46637569
Amyloidosis	28.00	20.56	16	46006	1095	46638945
Pancytopenia	27.95	20.56	161	45861	84897	46555143
Monoclonal immunoglobulin increased	27.59	20.56	8	46014	88	46639952
Tooth infection	27.51	20.56	46	45976	12240	46627800
SARS-CoV-2 test positive	26.67	20.56	19	46003	1906	46638134
Off label use	26.56	20.56	243	45779	379598	46260442
International normalised ratio increased	26.02	20.56	7	46015	46876	46593164
Therapeutic product effect decreased	25.78	20.56	26	45996	82575	46557465
Liver function test abnormal	25.69	20.56	7	46015	46480	46593560
Ascites	25.62	20.56	3	46019	36581	46603459
Suicidal ideation	25.21	20.56	12	46010	56370	46583670
Memory impairment	25.16	20.56	146	45876	77191	46562849
Ear infection	25.08	20.56	64	45958	22949	46617091
Product quality issue	24.77	20.56	3	46019	35645	46604395
Bradycardia	24.17	20.56	18	46004	66280	46573760
Swelling face	24.12	20.56	110	45912	52949	46587091
Osteoarthritis	23.72	20.56	16	46006	62009	46578031
Localised infection	23.70	20.56	64	45958	23737	46616303
Pseudomonas aeruginosa meningitis	23.69	20.56	4	46018	0	46640040
Cystitis	23.40	20.56	93	45929	42148	46597892
Cardiac amyloidosis	23.36	20.56	11	46011	503	46639537
Lower limb fracture	23.33	20.56	43	45979	12355	46627685
Dysphonia	23.26	20.56	87	45935	38327	46601713
Hepatic enzyme increased	23.04	20.56	28	45994	81759	46558281
Mobility decreased	22.68	20.56	16	46006	60578	46579462
Peritonitis viral	22.40	20.56	6	46016	48	46639992
Hypoglycaemia	22.18	20.56	13	46009	54336	46585704
Nervousness	22.06	20.56	70	45952	28405	46611635
Malignant neoplasm progression	21.95	20.56	19	46003	64907	46575133
Loss of personal independence in daily activities	21.53	20.56	15	46007	57168	46582872
Fibromyalgia	21.09	20.56	5	46017	36458	46603582
JC virus CSF test positive	20.85	20.56	5	46017	24	46640016
Inappropriate schedule of product administration	20.82	20.56	20	46002	64993	46575047

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
Plasma cell myeloma	5844.74	19.58	2412	44335	51050	29854681
Death	1520.98	19.58	2280	44467	355003	29550728
Pneumonia	1399.02	19.58	2118	44629	332188	29573543
Full blood count decreased	827.77	19.58	430	46317	15287	29890444
White blood cell count decreased	662.28	19.58	732	46015	83215	29822516
Laboratory test abnormal	637.11	19.58	375	46372	17067	29888664
Adverse drug reaction	514.20	19.58	364	46383	22781	29882950
Fatigue	481.86	19.58	1334	45413	319339	29586392
Neuropathy peripheral	455.43	19.58	555	46192	69920	29835811
Influenza	441.32	19.58	434	46313	42964	29862767
Unevaluable event	376.59	19.58	346	46401	31439	29874292
Thrombosis	349.17	19.58	378	46369	41853	29863878
Neutropenia	342.16	19.58	671	46076	127869	29777862
Drug interaction	254.99	19.58	14	46733	199554	29706177
Plasma cell myeloma recurrent	243.73	19.58	115	46632	3299	29902432
Peripheral swelling	189.63	19.58	341	46406	60733	29844998
Nasopharyngitis	187.09	19.58	332	46415	58517	29847214
Platelet count decreased	171.32	19.58	455	46292	105674	29800057
Plasmacytoma	159.98	19.58	86	46661	3270	29902461
Infection	153.54	19.58	361	46386	77713	29828018
Neutrophil count decreased	144.62	19.58	247	46500	42207	29863524
Condition aggravated	138.92	19.58	24	46723	137842	29767889
COVID-19	130.35	19.58	150	46597	17728	29888003
Cardiac disorder	127.91	19.58	226	46521	39667	29866064
Constipation	119.04	19.58	417	46330	112489	29793242
Renal disorder	106.25	19.58	156	46591	23428	29882303
Drug intolerance	105.30	19.58	224	46523	45067	29860664
Overdose	104.25	19.58	7	46740	84330	29821401
Tooth disorder	103.09	19.58	97	46650	9064	29896667
Back pain	98.82	19.58	368	46379	102228	29803503
Plasma cell leukaemia	91.02	19.58	39	46708	886	29904845
Deep vein thrombosis	86.15	19.58	248	46499	60253	29845478
Asthenia	84.27	19.58	612	46135	220678	29685053
Sepsis	81.31	19.58	446	46301	145949	29759782
Rash	76.67	19.58	537	46210	191352	29714379
Vomiting	75.36	19.58	143	46604	219675	29686056
Rhabdomyolysis	73.76	19.58	7	46740	63573	29842158
Aspartate aminotransferase increased	73.53	19.58	7	46740	63415	29842316
Localised infection	72.44	19.58	98	46649	13639	29892092
Full blood count increased	72.19	19.58	32	46715	791	29904940
Light chain analysis increased	71.69	19.58	34	46713	986	29904745
Muscle spasms	71.28	19.58	243	46504	64595	29841136
Immune system disorder	69.81	19.58	56	46691	4221	29901510
Hyponatraemia	66.96	19.58	12	46735	67190	29838541
Product dose omission issue	66.28	19.58	301	46446	91330	29814401
Alanine aminotransferase increased	64.50	19.58	18	46729	74258	29831473
Blood count abnormal	62.77	19.58	84	46663	11568	29894163
Acute kidney injury	61.76	19.58	220	46527	273622	29632109
Abdominal pain	61.19	19.58	73	46674	135581	29770150
Monoclonal immunoglobulin present	59.97	19.58	29	46718	879	29904852
Atrial fibrillation	59.68	19.58	329	46418	107795	29797936
Product use in unapproved indication	58.40	19.58	21	46726	73672	29832059
Illness	57.78	19.58	45	46702	3249	29902482
Agitation	57.61	19.58	8	46739	54065	29851666
Malignant neoplasm progression	54.94	19.58	22	46725	72265	29833466
Hypoglycaemia	53.24	19.58	8	46739	50973	29854758
Toxicity to various agents	52.53	19.58	125	46622	177058	29728673
Bronchitis	52.42	19.58	157	46590	38968	29866763
Rheumatoid arthritis	52.14	19.58	3	46744	41194	29864537
Blood test abnormal	48.29	19.58	51	46696	5474	29900257
Hyperkalaemia	47.13	19.58	22	46725	65988	29839743
Intentional product use issue	45.08	19.58	3	46744	36437	29869294
Psoriasis	43.64	19.58	7	46740	42499	29863232
Squamous cell carcinoma of skin	43.62	19.58	62	46685	9033	29896698
Red blood cell count decreased	43.50	19.58	114	46633	26207	29879524
Rib fracture	43.25	19.58	74	46673	12646	29893085
Anxiety	43.07	19.58	46	46701	89825	29815906
Cytopenia	42.16	19.58	58	46689	8198	29897533
Fluid retention	42.06	19.58	109	46638	24889	29880842
Hypokalaemia	42.03	19.58	13	46734	50179	29855552
Headache	41.99	19.58	145	46602	182161	29723570
Arthropathy	41.91	19.58	97	46650	20630	29885101
Suicide attempt	40.11	19.58	5	46742	36692	29869039
Back disorder	39.87	19.58	48	46699	5946	29899785
Upper limb fracture	39.56	19.58	40	46707	4080	29901651
Aggression	38.06	19.58	6	46741	36901	29868830
Pulmonary thrombosis	37.69	19.58	48	46699	6295	29899436
Wrong technique in product usage process	37.29	19.58	3	46744	31152	29874579
International normalised ratio increased	37.14	19.58	14	46733	47725	29858006
Hypotension	37.05	19.58	174	46573	200391	29705340
Dyspnoea	37.01	19.58	727	46020	332568	29573163
Nausea	36.88	19.58	292	46455	296665	29609066
Ascites	36.68	19.58	6	46741	35915	29869816
Electrocardiogram QT prolonged	36.56	19.58	6	46741	35829	29869902
Respiratory tract infection	36.35	19.58	77	46670	15429	29890302
Bone pain	36.25	19.58	87	46660	18939	29886792
Seizure	34.60	19.58	63	46684	98412	29807319
Hip fracture	34.30	19.58	62	46685	11062	29894669
Jaundice	34.14	19.58	5	46742	32481	29873250
Cardio-respiratory arrest	33.91	19.58	24	46723	57282	29848449
Malaise	33.52	19.58	403	46344	166559	29739172
Interstitial lung disease	33.33	19.58	27	46720	60170	29845561
Coronary artery disease	33.33	19.58	18	46729	49694	29856037
General physical health deterioration	33.30	19.58	66	46681	99878	29805853
Protein total increased	32.88	19.58	27	46720	2103	29903628
Hospitalisation	32.84	19.58	14	46733	44305	29861426
Balance disorder	32.66	19.58	128	46619	36365	29869366
Cataract	32.49	19.58	91	46656	21744	29883987
Bone lesion	31.56	19.58	29	46718	2628	29903103
Blood calcium increased	31.54	19.58	31	46716	3056	29902675
Pancreatitis	31.37	19.58	9	46738	36481	29869250
Coma	31.23	19.58	12	46735	40437	29865294
Cardiac arrest	31.21	19.58	61	46686	92789	29812942
Lower respiratory tract infection	30.99	19.58	102	46645	26612	29879119
Drug reaction with eosinophilia and systemic symptoms	30.85	19.58	4	46743	28484	29877247
Sinusitis	30.69	19.58	118	46629	33227	29872504
Blood urea increased	30.40	19.58	6	46741	31375	29874356
Hypercalcaemia	30.40	19.58	63	46684	12432	29893299
Lactic acidosis	30.17	19.58	6	46741	31207	29874524
Depressed level of consciousness	30.08	19.58	11	46736	38211	29867520
Body height decreased	30.05	19.58	33	46714	3701	29902030
Melaena	29.80	19.58	7	46740	32430	29873301
Neutropenic sepsis	29.51	19.58	59	46688	11350	29894381
Spinal fracture	29.46	19.58	44	46703	6704	29899027
Fall	29.40	19.58	422	46325	181450	29724281
White blood cell count abnormal	29.37	19.58	28	46719	2658	29903073
Dysarthria	29.18	19.58	6	46741	30484	29875247
Gastric disorder	29.06	19.58	56	46691	10487	29895244
Injection site pain	28.93	19.58	6	46741	30304	29875427
Gastrointestinal haemorrhage	28.76	19.58	54	46693	83392	29822339
Inappropriate schedule of product administration	28.72	19.58	13	46734	39715	29866016
SARS-CoV-2 test positive	28.11	19.58	22	46725	1600	29904131
Blood bilirubin increased	28.07	19.58	11	46736	36625	29869106
Tachycardia	27.88	19.58	45	46702	73694	29832037
Gamma-glutamyltransferase increased	27.63	19.58	6	46741	29344	29876387
Haematuria	27.56	19.58	18	46729	44816	29860915
Musculoskeletal disorder	27.49	19.58	36	46711	4853	29900878
Multiple allergies	26.65	19.58	24	46723	2119	29903612
Metabolic acidosis	25.94	19.58	13	46734	37448	29868283
Tooth infection	25.80	19.58	36	46711	5155	29900576
Drug hypersensitivity	25.73	19.58	42	46705	68477	29837254
Cerebral toxoplasmosis	25.58	19.58	20	46727	1452	29904279
Respiratory arrest	25.55	19.58	7	46740	29251	29876480
Angioedema	25.25	19.58	11	46736	34373	29871358
Incorrect dose administered	25.14	19.58	9	46738	31677	29874054
Blood immunoglobulin M increased	24.79	19.58	10	46737	194	29905537
Bradycardia	24.76	19.58	40	46707	65486	29840245
Acute myocardial infarction	24.36	19.58	28	46719	52911	29852820
Arthralgia	24.34	19.58	119	46628	135672	29770059
Hepatic function abnormal	24.25	19.58	18	46729	41927	29863804
Respiration abnormal	24.18	19.58	25	46722	2617	29903114
Agranulocytosis	23.95	19.58	3	46744	21939	29883792
Ear infection	23.89	19.58	42	46705	7332	29898399
Haematemesis	23.39	19.58	6	46741	26197	29879534
Psychotic disorder	23.34	19.58	3	46744	21512	29884219
Shock	22.93	19.58	4	46743	22855	29882876
Blood pressure abnormal	22.85	19.58	40	46707	6959	29898772
Pyrexia	22.25	19.58	609	46138	293880	29611851
Seasonal allergy	22.20	19.58	32	46715	4721	29901010
Blood creatinine increased	22.15	19.58	71	46676	91304	29814427
Hypoacusis	22.10	19.58	60	46687	14079	29891652
Blood lactate dehydrogenase increased	22.05	19.58	3	46744	20598	29885133
Lower limb fracture	21.99	19.58	28	46719	3671	29902060
White blood cell disorder	21.73	19.58	17	46730	1235	29904496
Blood alkaline phosphatase increased	21.69	19.58	11	46736	31476	29874255
Transaminases increased	21.67	19.58	5	46742	23452	29882279
Encephalopathy	21.09	19.58	12	46735	32193	29873538
Oxygen saturation decreased	21.06	19.58	22	46725	43418	29862313
Sinus disorder	20.88	19.58	36	46711	6189	29899542
Clostridium difficile infection	20.81	19.58	63	46684	15720	29890011
Spinal disorder	20.72	19.58	26	46721	3359	29902372
Mucosal inflammation	20.49	19.58	11	46736	30483	29875248
White blood cell count increased	20.49	19.58	19	46728	39654	29866077
Ventricular tachycardia	20.30	19.58	6	46741	23856	29881875
Gastrointestinal infection	20.06	19.58	27	46720	3738	29901993
Drug ineffective	20.00	19.58	393	46354	339994	29565737
Hepatic enzyme increased	19.85	19.58	14	46733	33480	29872251
Vertebral lesion	19.84	19.58	8	46739	155	29905576

Pharmacologic Action:

Source	Code	Description
ATC	L04AX06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Other immunosuppressants
MeSH PA	D020533	Angiogenesis Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D006131	Growth Inhibitors
MeSH PA	D006133	Growth Substances
MeSH PA	D007155	Immunologic Factors
FDA EPC	N0000184014	Thalidomide Analog
CHEBI has role	CHEBI:35610	cytostatic
CHEBI has role	CHEBI:48422	angiostatic agents
CHEBI has role	CHEBI:50846	biomodulator

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Multiple myeloma	indication	109989006	DOID:9538

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.84	acidic
pKa2	1.86	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
1MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 20, 2023	ADDITIONULLL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
2MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 20, 2023	ADDITIONULLL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
3MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 20, 2023	ADDITIONULLL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
4MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 20, 2023	ADDITIONULLL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
1MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 20, 2024	PEDIATRIC EXCLUSIVITY
2MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 20, 2024	PEDIATRIC EXCLUSIVITY
3MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 20, 2024	PEDIATRIC EXCLUSIVITY
4MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 20, 2024	PEDIATRIC EXCLUSIVITY
1MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
1MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
2MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
2MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
3MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
3MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
4MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
4MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	May 14, 2027	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
1MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 14, 2027	PEDIATRIC EXCLUSIVITY
2MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 14, 2027	PEDIATRIC EXCLUSIVITY
3MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 14, 2027	PEDIATRIC EXCLUSIVITY
4MG	POMALYST	CELGENE	N204026	Feb. 8, 2013	RX	CAPSULE	ORAL	Nov. 14, 2027	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Protein cereblon	Cytosolic other	Q96SW2	CRBN_HUMAN	MODULATOR	EC50	6.58		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

ID	Source
D08976	KEGG_DRUG
4032092	VANDF
C2347625	UMLSCUI
CHEBI:72690	CHEBI
134780	PUBCHEM_CID
CHEMBL43452	ChEMBL_ID
DB08910	DRUGBANK_ID
C467566	MESH_SUPPLEMENTAL_RECORD_UI
7348	IUPHAR_LIGAND_ID
8873	INN_ID
D2UX06XLB5	UNII
1369713	RXNORM
199372	MMSL
29234	MMSL
d08041	MMSL
014897	NDDF
703789000	SNOMEDCT_US
703790009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pomalyst	HUMAN PRESCRIPTION DRUG LABEL	1	59572-501	CAPSULE	1 mg	ORAL	NDA	35 sections
Pomalyst	HUMAN PRESCRIPTION DRUG LABEL	1	59572-502	CAPSULE	2 mg	ORAL	NDA	35 sections
Pomalyst	HUMAN PRESCRIPTION DRUG LABEL	1	59572-503	CAPSULE	3 mg	ORAL	NDA	35 sections
Pomalyst	HUMAN PRESCRIPTION DRUG LABEL	1	59572-504	CAPSULE	4 mg	ORAL	NDA	35 sections