All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

methoxy polyethylene glycol-epoetin beta 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
erythropoietin type blood factors	5165	677324-53-7

Description:

Molecule	Description
Synonyms: methoxy polyethylene glycol-epoetin beta mircera	A pegylated form of recombinant human erythropoietin, a glycosylated protein naturally produced in the kidney that stimulates erythrocyte production in the bone marrow. Methoxypolyethylene glycol epoetin beta may reverse anemias induced by cancer therapy Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
4	mcg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Nov. 14, 2007	FDA	HOFFMAN-LA ROCHE
July 20, 2007	EMA	Roche Registration GmbH

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
Drug hypersensitivity	3951.38	34.40	1615	9569	461994	90155269
Flushing	613.29	34.40	271	10913	88220	90529043
Dyspnoea	476.00	34.40	560	10624	880395	89736868
Pruritus	443.35	34.40	430	10754	541095	90076168
Aplasia pure red cell	385.93	34.40	96	11088	5098	90612165
Death	371.98	34.40	362	10822	456189	90161074
Unresponsive to stimuli	361.13	34.40	146	11038	37975	90579288
Feeling hot	349.24	34.40	177	11007	77831	90539432
Vomiting	254.13	34.40	391	10793	787902	89829361
Nausea	251.42	34.40	470	10714	1109846	89507417
Haemoglobin decreased	236.76	34.40	180	11004	161776	90455487
No adverse event	224.39	34.40	126	11058	67856	90549407
Marasmus	140.79	34.40	30	11154	793	90616470
Inappropriate schedule of product administration	138.61	34.40	128	11056	149805	90467458
Pulse absent	116.06	34.40	39	11145	6016	90611247
Back pain	106.50	34.40	161	11023	317014	90300249
Shunt occlusion	92.34	34.40	21	11163	754	90616509
Blood pressure decreased	83.17	34.40	71	11113	74824	90542439
Shunt stenosis	76.70	34.40	17	11167	542	90616721
Drug ineffective	73.53	34.40	40	11144	1384258	89233005
Erythema	66.61	34.40	109	11075	229137	90388126
Chest pain	58.95	34.40	125	11059	319520	90297743
Haemoglobin increased	58.42	34.40	25	11159	7456	90609807
Agonal respiration	56.57	34.40	11	11173	181	90617082
Hypotension	56.28	34.40	124	11060	325273	90291990
Serum ferritin increased	55.45	34.40	24	11160	7357	90609906
Hyperhidrosis	54.09	34.40	75	11109	136230	90481033
Arthralgia	49.91	34.40	17	11167	778505	89838758
Off label use	48.73	34.40	39	11145	1102213	89515050
Blood pressure increased	47.07	34.40	86	11098	197131	90420132
Cardiac failure	46.08	34.40	62	11122	109434	90507829
Urticaria	45.10	34.40	111	11073	312623	90304640
Loss of consciousness	43.86	34.40	69	11115	140169	90477094
Seizure like phenomena	43.44	34.40	13	11171	1377	90615886
Throat tightness	43.44	34.40	33	11151	29451	90587812
Chest discomfort	41.78	34.40	67	11117	138298	90478965
Fatigue	41.53	34.40	49	11135	1153974	89463289
Alopecia	41.31	34.40	6	11178	495065	90122198
Anaemia	38.53	34.40	113	11071	352689	90264574
Infusion related reaction	37.32	34.40	4	11180	416776	90200487
Reticulocyte count decreased	36.39	34.40	9	11175	465	90616798

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
Drug hypersensitivity	3874.07	28.31	1302	10026	98087	42511920
Flushing	487.89	28.31	224	11104	36804	42573203
Aplasia pure red cell	468.70	28.31	141	11187	7025	42602982
Pruritus	391.96	28.31	354	10974	188417	42421590
Death	333.77	28.31	507	10821	470678	42139329
Dyspnoea	299.99	28.31	467	10861	442154	42167853
Feeling hot	299.38	28.31	139	11189	23343	42586664
No adverse event	261.98	28.31	150	11178	38871	42571136
Haemoglobin decreased	223.55	28.31	222	11106	132249	42477758
Unresponsive to stimuli	216.84	28.31	123	11205	31280	42578727
Nausea	125.07	28.31	304	11024	396495	42213512
Haemoglobin increased	116.65	28.31	46	11282	5160	42604847
Vomiting	114.49	28.31	243	11085	289480	42320527
Inappropriate schedule of product administration	98.09	28.31	124	11204	95778	42514229
Blood iron decreased	85.41	28.31	39	11289	6279	42603728
Erythema	84.39	28.31	123	11205	108670	42501337
Urticaria	76.08	28.31	96	11232	73940	42536067
Hyperhidrosis	74.07	28.31	105	11223	90407	42519600
Serum ferritin increased	71.52	28.31	36	11292	7183	42602824
Blood pressure decreased	70.28	28.31	82	11246	58250	42551757
Off label use	68.35	28.31	43	11285	638292	41971715
Pulse absent	66.96	28.31	33	11295	6294	42603713
Drug ineffective	54.10	28.31	53	11275	630144	41979863
Seizure like phenomena	52.42	28.31	17	11311	1080	42608927
Marasmus	51.52	28.31	16	11312	883	42609124
Ventricular hyperkinesia	51.02	28.31	12	11316	226	42609781
Right atrial enlargement	48.74	28.31	12	11316	276	42609731
Hypochromasia	47.08	28.31	12	11316	319	42609688
Agonal respiration	44.01	28.31	9	11319	85	42609922
Mitral valve thickening	42.66	28.31	12	11316	468	42609539
Throat tightness	41.66	28.31	28	11300	9571	42600436
Mean platelet volume increased	39.18	28.31	12	11316	632	42609375
Reticulocyte count decreased	38.11	28.31	12	11316	693	42609314
Left ventricular enlargement	36.15	28.31	12	11316	820	42609187
Weight decreased	36.05	28.31	6	11322	207942	42402065
Drug interaction	36.05	28.31	13	11315	266986	42343021
Chest pain	35.47	28.31	99	11229	139431	42470576
Shunt occlusion	33.68	28.31	12	11316	1015	42608992
Left atrial enlargement	33.59	28.31	12	11316	1023	42608984
Hypertension	30.75	28.31	106	11222	167098	42442909
Chest discomfort	30.48	28.31	58	11270	63558	42546449
Anaemia	29.03	28.31	149	11179	280129	42329878
Acute kidney injury	29.02	28.31	33	11295	367304	42242703
Dizziness	29.01	28.31	137	11191	249117	42360890
Shunt stenosis	29.01	28.31	10	11318	767	42609240
High density lipoprotein decreased	28.85	28.31	16	11312	3881	42606126
Back pain	28.84	28.31	93	11235	141683	42468324
Product use in unapproved indication	28.48	28.31	7	11321	184449	42425558

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
Drug hypersensitivity	7556.81	28.25	2872	17579	451218	110117630
Flushing	1104.90	28.25	486	19965	104250	110464598
Pruritus	838.27	28.25	757	19694	580803	109988045
Dyspnoea	785.72	28.25	987	19464	1105885	109462963
Feeling hot	611.79	28.25	310	20141	90796	110478052
Unresponsive to stimuli	579.29	28.25	267	20184	63523	110505325
Aplasia pure red cell	567.46	28.25	161	20290	9417	110559431
No adverse event	445.69	28.25	234	20217	73605	110495243
Nausea	374.23	28.25	748	19703	1234942	109333906
Vomiting	343.14	28.25	606	19845	910069	109658779
Haemoglobin decreased	255.09	28.25	270	20181	248457	110320391
Inappropriate schedule of product administration	232.07	28.25	234	20217	203403	110365445
Death	224.50	28.25	435	20016	698434	109870414
Pulse absent	185.11	28.25	72	20379	11220	110557628
Blood pressure decreased	170.50	28.25	153	20298	114938	110453910
Marasmus	154.41	28.25	40	20411	1651	110567197
Erythema	154.03	28.25	227	20224	291220	110277628
Back pain	143.99	28.25	251	20200	370745	110198103
Hyperhidrosis	143.60	28.25	175	20276	187123	110381725
Drug ineffective	119.22	28.25	67	20384	1520473	109048375
Serum ferritin increased	111.77	28.25	51	20400	11796	110557052
Off label use	100.17	28.25	79	20372	1500106	109068742
Urticaria	97.65	28.25	195	20256	318662	110250186
Agonal respiration	96.28	28.25	20	20431	304	110568544
Haemoglobin increased	94.64	28.25	42	20409	9105	110559743
Shunt stenosis	93.83	28.25	26	20425	1390	110567458
Chest pain	93.11	28.25	211	20240	376164	110192684
Seizure like phenomena	92.19	28.25	29	20422	2412	110566436
Shunt occlusion	88.57	28.25	26	20425	1711	110567137
Throat tightness	87.10	28.25	62	20389	33427	110535421
Hypotension	78.80	28.25	244	20207	523605	110045243
Arthralgia	77.50	28.25	24	20427	779608	109789240
Chest discomfort	75.74	28.25	124	20327	173724	110395124
Blood pressure increased	73.12	28.25	153	20298	258220	110310628
Blood iron decreased	70.31	28.25	44	20407	19170	110549678
Loss of consciousness	69.81	28.25	128	20323	196178	110372670
Condition aggravated	59.35	28.25	31	20420	734805	109834043
Fatigue	57.66	28.25	85	20366	1215873	109352975
Cardiac failure	55.27	28.25	113	20338	187513	110381335
Infusion related reaction	55.12	28.25	4	20447	381158	110187690
Weight decreased	55.12	28.25	10	20441	468047	110100801
Ventricular hyperkinesia	51.77	28.25	12	20439	309	110568539
Weight increased	47.23	28.25	10	20441	419634	110149214
Heart rate increased	46.40	28.25	90	20361	143744	110425104
Right atrial enlargement	46.11	28.25	12	20439	504	110568344
Hepatic enzyme increased	44.63	28.25	4	20447	320888	110247960
Depression	44.01	28.25	4	20447	317331	110251517
Sinusitis	43.21	28.25	3	20448	296685	110272163
Hypochromasia	42.28	28.25	12	20439	700	110568148
Dizziness	42.03	28.25	246	20205	697947	109870901
Insomnia	41.80	28.25	8	20443	360582	110208266
Mitral valve thickening	41.37	28.25	12	20439	757	110568091
Anaemia	40.50	28.25	204	20247	546882	110021966
Drug interaction	40.49	28.25	21	20430	500162	110068686
Alopecia	40.41	28.25	9	20442	364744	110204104
Left ventricular enlargement	39.89	28.25	12	20439	859	110567989
Chronic kidney disease	39.57	28.25	59	20392	76232	110492616
Peripheral swelling	39.08	28.25	13	20438	404021	110164827
Product use in unapproved indication	38.94	28.25	17	20434	447360	110121488
Reticulocyte count decreased	38.67	28.25	12	20439	954	110567894
Rheumatoid arthritis	38.44	28.25	5	20446	299608	110269240
Pallor	37.23	28.25	49	20402	56418	110512430
High density lipoprotein decreased	36.90	28.25	19	20432	5714	110563134
Hypertension	36.20	28.25	188	20263	509896	110058952
Nasopharyngitis	35.91	28.25	14	20437	394347	110174501
Systemic lupus erythematosus	35.83	28.25	3	20448	254335	110314513
Anaphylactic reaction	35.02	28.25	70	20381	114230	110454618
Anti-erythropoietin antibody positive	33.20	28.25	10	20441	719	110568129
Blood parathyroid hormone increased	33.01	28.25	16	20435	4232	110564616
Mean platelet volume increased	32.70	28.25	12	20439	1592	110567256
Asthma	32.54	28.25	4	20447	250287	110318561
Left atrial enlargement	31.81	28.25	12	20439	1719	110567129
Transferrin decreased	31.48	28.25	9	20442	539	110568309
Lower respiratory tract infection	31.32	28.25	4	20447	243102	110325746
Pyrexia	30.89	28.25	76	20375	898189	109670659
Pain in extremity	30.65	28.25	27	20424	487091	110081757
Therapeutic product effect incomplete	30.55	28.25	3	20448	223802	110345046
Mobility decreased	30.36	28.25	4	20447	237418	110331430
Wound	29.86	28.25	4	20447	234433	110334415
Confusional state	29.46	28.25	26	20425	468654	110100194
Blood urea increased	29.21	28.25	43	20408	54914	110513934
Documented hypersensitivity to administered product	28.86	28.25	10	20441	1124	110567724
Blood phosphorus increased	28.77	28.25	24	20427	16316	110552532

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B03XA03	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS OTHER ANTIANEMIC PREPARATIONS Other antianemic preparations
CHEBI has role	CHEBI:75835	anti-anaemic agent
CHEBI has role	CHEBI:231911	renoprotective agent

Related Drugs by ATC class:

B03XA Other antianemic preparations 8 drugs

daprodustatdarbepoetin alfaepoetin alfaluspaterceptmolidustatpeginesatideroxadustatvadadustat

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

Disease	Relation	SNOMED_ID	DOID
Anemia in chronic kidney disease	indication	707323002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Erythropoietin receptor	Membrane receptor	P19235	EPOR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
LR3UXN0193	UNII
4026967	VANDF
C1328071	UMLSCUI
CHEBI:755792	CHEBI
CHEMBL3707314	ChEMBL_ID
DB09107	DRUGBANK_ID
C508420	MESH_SUPPLEMENTAL_RECORD_UI
1591957	RXNORM
425913002	SNOMEDCT_US
426360006	SNOMEDCT_US
120086	MMSL
24326	MMSL
d06911	MMSL
012324	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-400	INJECTION, SOLUTION	30 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-401	INJECTION, SOLUTION	50 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-402	INJECTION, SOLUTION	75 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-403	INJECTION, SOLUTION	100 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-404	INJECTION, SOLUTION	150 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-405	INJECTION, SOLUTION	200 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-406	INJECTION, SOLUTION	250 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-407	INJECTION, SOLUTION	120 ug	INTRAVENOUS	BLA	31 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-408	INJECTION, SOLUTION	360 ug	INTRAVENOUS	BLA	31 sections