peginterferon beta-1a 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5137	1211327-92-2

Description:

Molecule	Description
Synonyms: peginterferon beta-1a plegridy BIIB017	an interferon beta-1a to which a single, linear 20,000 dalton methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde molecule is covalently attached to the alpha amino group of the N-terminal amino acid residue. A possible role for IFNs in prophylaxis or early treatment of COVID-19 has been suggested to compensate for possibly insufficient endogenous IFN production. However, the efficacy and safety of IFNs for treatment or prevention of COVID-19 were not established. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

peginterferon beta-1a
plegridy
BIIB017

an interferon beta-1a to which a single, linear 20,000 dalton methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde molecule is covalently attached to the alpha amino group of the N-terminal amino acid residue. A possible role for IFNs in prophylaxis or early treatment of COVID-19 has been suggested to compensate for possibly insufficient endogenous IFN production. However, the efficacy and safety of IFNs for treatment or prevention of COVID-19 were not established.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
8.90	mcg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Aug. 15, 2014	FDA	BIOGEN IDEC INC

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
Influenza like illness	645.19	24.26	235	5284	66589	63416914
Multiple sclerosis relapse	439.34	24.26	163	5356	48315	63435188
Injection site erythema	360.58	24.26	165	5354	83009	63400494
Injection site reaction	231.11	24.26	109	5410	58415	63425088
Device malfunction	128.87	24.26	51	5468	17806	63465697
Injection site pruritus	86.54	24.26	52	5467	45064	63438439
General symptom	81.84	24.26	23	5496	2785	63480718
Maternal exposure during pregnancy	68.96	24.26	90	5429	219972	63263531
Injection site bruising	66.92	24.26	43	5476	41867	63441636
Injection site rash	64.89	24.26	32	5487	18777	63464726
Abortion spontaneous	59.93	24.26	42	5477	47153	63436350
Injection site pain	58.61	24.26	64	5455	129736	63353767
Drug delivery system malfunction	50.51	24.26	13	5506	1127	63482376
Adverse reaction	43.23	24.26	20	5499	10183	63473320
Chills	39.58	24.26	49	5470	113329	63370174
Injection site swelling	35.65	24.26	31	5488	47541	63435962
Off label use	32.99	24.26	9	5510	674453	62809050
Needle fatigue	31.76	24.26	6	5513	122	63483381
Caesarean section	31.00	24.26	19	5500	17013	63466490
Procedural anxiety	30.28	24.26	8	5511	768	63482735
Magnetic resonance imaging abnormal	30.13	24.26	11	5508	3074	63480429
Product dose omission issue	28.67	24.26	63	5456	234250	63249253
Anal polyp	27.96	24.26	5	5514	74	63483429
Central nervous system lesion	27.74	24.26	15	5504	10620	63472883
Lymphopenia	27.26	24.26	18	5501	18309	63465194
White blood cell count decreased	26.33	24.26	45	5474	139059	63344444
Product administered to patient of inappropriate age	25.90	24.26	10	5509	3258	63480245

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
Influenza like illness	322.32	39.47	85	857	27549	34928440
Multiple sclerosis relapse	136.11	39.47	37	905	13096	34942893
Injection site reaction	82.31	39.47	25	917	13008	34942981
Injection site erythema	81.53	39.47	26	916	15873	34940116

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
Influenza like illness	618.80	27.69	209	4408	71498	79668273
Multiple sclerosis relapse	417.84	27.69	140	4477	46393	79693378
Injection site erythema	350.41	27.69	141	4476	78056	79661715
Injection site reaction	178.79	27.69	79	4538	54706	79685065
Device malfunction	96.83	27.69	39	4578	21409	79718362
Injection site pruritus	85.75	27.69	44	4573	42239	79697532
Injection site bruising	69.89	27.69	38	4579	40964	79698807
Maternal exposure during pregnancy	65.77	27.69	58	4559	136480	79603291
Injection site rash	65.34	27.69	28	4589	17926	79721845
Chills	61.57	27.69	60	4557	160174	79579597
Injection site pain	60.23	27.69	54	4563	129784	79609987
Abortion spontaneous	52.09	27.69	28	4589	29479	79710292
Drug delivery system malfunction	50.43	27.69	11	4606	706	79739065
Injection site swelling	33.16	27.69	25	4592	47107	79692664
Product administered to patient of inappropriate age	31.77	27.69	12	4605	5541	79734230
Product dose omission issue	30.81	27.69	53	4564	247484	79492287
Loss of control of legs	30.46	27.69	9	4608	1956	79737815
Magnetic resonance imaging abnormal	29.32	27.69	10	4607	3449	79736322
Anal polyp	29.12	27.69	5	4612	89	79739682
General symptom	28.20	27.69	9	4608	2525	79737246

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L03AB13	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSTIMULANTS IMMUNOSTIMULANTS Interferons
FDA CS	M0025715	Interferon-beta
FDA EPC	N0000191625	Interferon beta

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

Disease	Relation	SNOMED_ID	DOID
Relapsing remitting multiple sclerosis	indication	426373005	DOID:2378

🐶 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
Interferon alpha/beta receptor	Membrane receptor	P17181 P48551	INAR1_HUMAN INAR2_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
I8309403R0	UNII
4033770	VANDF
C3848580	UMLSCUI
CHEMBL2108677	ChEMBL_ID
D10483	KEGG_DRUG
DB09122	DRUGBANK_ID
9661	INN_ID
7637	IUPHAR_LIGAND_ID
1546168	RXNORM
227899	MMSL
30489	MMSL
d08282	MMSL
015648	NDDF
706897007	SNOMEDCT_US
714201001	SNOMEDCT_US
C428112	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PlegridyPen	HUMAN PRESCRIPTION DRUG LABEL	1	64406-011	INJECTION, SOLUTION	125 ug	SUBCUTANEOUS	BLA	27 sections
PlegridyPen	HUMAN PRESCRIPTION DRUG LABEL	1	64406-011	INJECTION, SOLUTION	125 ug	SUBCUTANEOUS	BLA	27 sections
PlegridyPen	HUMAN PRESCRIPTION DRUG LABEL	1	64406-011	INJECTION, SOLUTION	125 ug	SUBCUTANEOUS	BLA	27 sections
Plegridy	HUMAN PRESCRIPTION DRUG LABEL	1	64406-015	INJECTION, SOLUTION	125 ug	SUBCUTANEOUS	BLA	27 sections
Plegridy	HUMAN PRESCRIPTION DRUG LABEL	1	64406-015	INJECTION, SOLUTION	125 ug	SUBCUTANEOUS	BLA	27 sections
Plegridy	HUMAN PRESCRIPTION DRUG LABEL	1	64406-015	INJECTION, SOLUTION	125 ug	SUBCUTANEOUS	BLA	27 sections
Plegridy	HUMAN PRESCRIPTION DRUG LABEL	1	64406-017	INJECTION, SOLUTION	125 ug	INTRAMUSCULAR	BLA	27 sections
Plegridy	HUMAN PRESCRIPTION DRUG LABEL	1	64406-017	INJECTION, SOLUTION	125 ug	INTRAMUSCULAR	BLA	27 sections
Plegridy	HUMAN PRESCRIPTION DRUG LABEL	1	64406-017	INJECTION, SOLUTION	125 ug	INTRAMUSCULAR	BLA	27 sections