methoxy polyethylene glycol-epoetin beta 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

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

Approvals:

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

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	2557.32	32.71	1087	7503	309600	63170832
Flushing	408.26	32.71	200	8390	74887	63405545
Pruritus	401.14	32.71	354	8236	361099	63119333
Aplasia pure red cell	311.46	32.71	80	8510	4407	63476025
Dyspnoea	272.99	32.71	386	8204	660927	62819505
No adverse event	272.71	32.71	126	8464	41279	63439153
Death	255.98	32.71	282	8308	374099	63106333
Feeling hot	220.35	32.71	116	8474	50238	63430194
Unresponsive to stimuli	195.17	32.71	94	8496	33722	63446710
Haemoglobin decreased	173.26	32.71	149	8441	145336	63335096
Vomiting	168.38	32.71	283	8307	559334	62921098
Inappropriate schedule of product administration	158.47	32.71	123	8467	103842	63376590
Marasmus	151.50	32.71	30	8560	495	63479937
Nausea	145.38	32.71	340	8250	854131	62626301
Shunt occlusion	88.19	32.71	20	8570	645	63479787
Shunt stenosis	75.73	32.71	17	8573	523	63479909
Pulse absent	64.20	32.71	25	8565	5349	63475083
Blood pressure decreased	60.33	32.71	58	8532	64964	63415468
Urticaria	59.14	32.71	91	8499	165711	63314721
Drug ineffective	55.40	32.71	37	8553	1044728	62435704
Chest pain	51.31	32.71	99	8491	215860	63264572
Back pain	47.48	32.71	108	8482	264037	63216395
Cardiac failure	46.86	32.71	59	8531	89083	63391349
Hyperhidrosis	40.98	32.71	61	8529	107775	63372657
Arthralgia	39.43	32.71	14	8576	569696	62910736
Agonal respiration	37.80	32.71	6	8584	24	63480408
Anaemia	36.10	32.71	104	8486	293326	63187106
Fatigue	34.36	32.71	42	8548	887986	62592446

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	2374.94	28.46	851	8104	79678	34868298
Aplasia pure red cell	393.98	28.46	118	8837	6014	34941962
Pruritus	354.19	28.46	291	8664	141690	34806286
Flushing	337.88	28.46	165	8790	32255	34915721
No adverse event	330.10	28.46	146	8809	22781	34925195
Death	262.21	28.46	406	8549	397643	34550333
Dyspnoea	185.45	28.46	338	8617	376444	34571532
Haemoglobin decreased	176.32	28.46	184	8771	120588	34827388
Inappropriate schedule of product administration	140.70	28.46	121	8834	62175	34885801
Unresponsive to stimuli	131.38	28.46	84	8871	27485	34920491
Feeling hot	131.19	28.46	74	8881	19298	34928678
Nausea	74.83	28.46	223	8732	339685	34608291
Vomiting	69.83	28.46	178	8777	247443	34700533
Urticaria	68.33	28.46	82	8873	62295	34885681
Marasmus	58.55	28.46	16	8939	582	34947394
Haemoglobin increased	53.13	28.46	23	8932	3386	34944590
Ventricular hyperkinesia	52.62	28.46	12	8943	204	34947772
Blood pressure decreased	50.39	28.46	64	8891	51451	34896525
Right atrial enlargement	50.26	28.46	12	8943	251	34947725
Erythema	50.02	28.46	85	8870	88695	34859281
Hypochromasia	47.89	28.46	12	8943	309	34947667
Anaemia	45.48	28.46	147	8808	233188	34714788
Mitral valve thickening	45.45	28.46	12	8943	382	34947594
Mean platelet volume increased	41.92	28.46	12	8943	518	34947458
Hypertension	40.31	28.46	100	8855	136343	34811633
Left ventricular enlargement	38.60	28.46	12	8943	690	34947286
Off label use	38.26	28.46	31	8924	419493	34528483
Hyperhidrosis	38.11	28.46	69	8886	75623	34872353
Blood iron decreased	37.84	28.46	21	8934	5292	34942684
Shunt occlusion	36.06	28.46	12	8943	858	34947118
Left atrial enlargement	35.60	28.46	12	8943	893	34947083
Serum ferritin increased	35.00	28.46	21	8934	6125	34941851
Cardiac failure	32.51	28.46	72	8883	91176	34856800
Seizure like phenomena	29.54	28.46	10	8945	754	34947222
Shunt stenosis	29.31	28.46	10	8945	772	34947204
Drug interaction	28.74	28.46	11	8944	225935	34722041

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	4854.13	27.16	1895	13816	297021	79431656
Pruritus	756.62	27.16	621	15090	394027	79334650
Flushing	736.80	27.16	355	15356	87913	79640764
No adverse event	582.00	27.16	233	15478	36959	79691718
Aplasia pure red cell	502.70	27.16	142	15569	7668	79721009
Dyspnoea	454.67	27.16	687	15024	856338	78872339
Feeling hot	334.63	27.16	184	15527	59550	79669127
Unresponsive to stimuli	323.98	27.16	176	15535	55612	79673065
Inappropriate schedule of product administration	289.66	27.16	227	15484	133401	79595276
Nausea	220.69	27.16	540	15171	956656	78772021
Vomiting	220.63	27.16	435	15276	665393	79063284
Haemoglobin decreased	171.96	27.16	215	15496	221904	79506773
Marasmus	171.68	27.16	40	15671	988	79727689
Blood pressure decreased	119.20	27.16	121	15590	99345	79629332
Urticaria	116.47	27.16	162	15549	185039	79543638
Death	113.41	27.16	304	15407	566210	79162467
Shunt stenosis	92.66	27.16	26	15685	1365	79727312
Shunt occlusion	90.65	27.16	26	15685	1478	79727199
Hyperhidrosis	84.17	27.16	125	15586	151367	79577310
Erythema	77.12	27.16	149	15562	223141	79505536
Drug ineffective	72.73	27.16	64	15647	1080849	78647828
Pulse absent	70.25	27.16	36	15675	10067	79718610
Chest pain	68.25	27.16	163	15548	282141	79446536
Back pain	65.48	27.16	168	15543	304012	79424665
Serum ferritin increased	56.88	27.16	31	15680	9816	79718861
Cardiac failure	56.71	27.16	106	15605	154736	79573941
Arthralgia	56.65	27.16	21	15690	571782	79156895
Hypertension	56.53	27.16	168	15543	330824	79397853
Seizure like phenomena	56.33	27.16	19	15692	1848	79726829
Throat tightness	55.15	27.16	45	15666	27862	79700815
Haemoglobin increased	55.02	27.16	26	15685	6106	79722571
Off label use	54.80	27.16	59	15652	907156	78821521
Ventricular hyperkinesia	51.86	27.16	12	15699	287	79728390
Chest discomfort	49.92	27.16	94	15617	137950	79590727
Anaemia	48.92	27.16	195	15516	444820	79283857
Right atrial enlargement	48.54	27.16	12	15699	383	79728294
Mitral valve thickening	47.61	27.16	12	15699	415	79728262
Weight decreased	46.99	27.16	7	15704	355191	79373486
Fatigue	45.29	27.16	71	15640	929656	78799021
Blood pressure increased	44.66	27.16	116	15595	211244	79517433
Hypochromasia	41.80	27.16	12	15699	684	79727993
Left ventricular enlargement	40.98	27.16	12	15699	734	79727943
Drug interaction	39.83	27.16	16	15695	415167	79313510
Condition aggravated	38.21	27.16	26	15685	501098	79227579
Anaphylactic reaction	37.98	27.16	63	15648	83680	79644997
Mean platelet volume increased	36.18	27.16	12	15699	1108	79727569
Left atrial enlargement	35.34	27.16	12	15699	1191	79727486
Rash	35.14	27.16	214	15497	578144	79150533
Agonal respiration	34.95	27.16	7	15704	82	79728595
Infusion related reaction	34.27	27.16	3	15708	230234	79498443
Pallor	30.21	27.16	43	15668	50019	79678658
Documented hypersensitivity to administered product	30.01	27.16	10	15701	937	79727740
Weight increased	29.48	27.16	9	15702	277377	79451300
Depression	29.29	27.16	4	15707	216786	79511891
Chronic kidney disease	28.97	27.16	49	15662	66105	79662572
Peripheral swelling	28.20	27.16	9	15702	269608	79459069

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

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
CHEMBL3707314	ChEMBL_ID
DB09107	DRUGBANK_ID
1591957	RXNORM
120086	MMSL
24326	MMSL
d06911	MMSL
012324	NDDF
425913002	SNOMEDCT_US
426360006	SNOMEDCT_US
C508420	MESH_SUPPLEMENTAL_RECORD_UI

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	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-400	INJECTION, SOLUTION	30 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-400	INJECTION, SOLUTION	30 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-401	INJECTION, SOLUTION	50 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-401	INJECTION, SOLUTION	50 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-401	INJECTION, SOLUTION	50 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-402	INJECTION, SOLUTION	75 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-402	INJECTION, SOLUTION	75 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-402	INJECTION, SOLUTION	75 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-403	INJECTION, SOLUTION	100 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-403	INJECTION, SOLUTION	100 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-403	INJECTION, SOLUTION	100 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-404	INJECTION, SOLUTION	150 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-404	INJECTION, SOLUTION	150 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-404	INJECTION, SOLUTION	150 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-405	INJECTION, SOLUTION	200 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-405	INJECTION, SOLUTION	200 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-405	INJECTION, SOLUTION	200 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-406	INJECTION, SOLUTION	250 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-406	INJECTION, SOLUTION	250 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-406	INJECTION, SOLUTION	250 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-407	INJECTION, SOLUTION	120 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-407	INJECTION, SOLUTION	120 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-407	INJECTION, SOLUTION	120 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-408	INJECTION, SOLUTION	360 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-408	INJECTION, SOLUTION	360 ug	INTRAVENOUS	BLA	29 sections
Mircera	HUMAN PRESCRIPTION DRUG LABEL	1	59353-408	INJECTION, SOLUTION	360 ug	INTRAVENOUS	BLA	29 sections