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

Stem definition	Drug id	CAS RN
human origin	5315	1655501-53-3

Description:

Molecule	Description
Synonyms: fremanezumab ajovy TEV-48125 LBR-101 RN307 PF-04472429 fremanezumab-vfrm fremanezumab (genetical recombination)	Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

fremanezumab
ajovy
TEV-48125
LBR-101
RN307
PF-04472429
fremanezumab-vfrm
fremanezumab (genetical recombination)

Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

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

Drug dosage:

Dose	Unit	Route
7.50	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
June 23, 2021	PMDA	OTSUKA PHARMACEUTICAL Co., Ltd.
March 28, 2019	EMA	TEVA GMBH
Sept. 14, 2018	FDA	TEVA PHARMS USA

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FDA Adverse Event Reporting System (Female)

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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
Injection site erythema	272.11	32.34	117	3272	83057	63402576
Injection site pruritus	224.94	32.34	86	3303	45030	63440603
Injection site rash	186.94	32.34	60	3329	18749	63466884
Injection site swelling	168.72	32.34	71	3318	47501	63438132
Injection site reaction	167.27	32.34	75	3314	58449	63427184
Injection site pain	146.15	32.34	89	3300	129711	63355922
Accidental exposure to product	128.39	32.34	50	3339	27355	63458278
Device leakage	110.50	32.34	32	3357	7064	63478569
Incorrect dose administered by device	106.55	32.34	28	3361	4320	63481313
Injection site urticaria	81.50	32.34	30	3359	14043	63471590

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FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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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
Injection site erythema	181.82	34.72	73	2304	78124	79663887
Injection site pruritus	181.58	34.72	62	2315	42221	79699790
Injection site swelling	134.11	34.72	51	2326	47081	79694930
Injection site rash	95.57	34.72	31	2346	17923	79724088
Injection site reaction	83.51	34.72	38	2339	54747	79687264
Injection site pain	62.32	34.72	42	2335	129796	79612215
Accidental exposure to product	54.97	34.72	24	2353	31298	79710713
Injection site urticaria	51.78	34.72	18	2359	12808	79729203
Device leakage	46.79	34.72	16	2361	10840	79731171
Drug dose omission by device	42.41	34.72	13	2364	6237	79735774

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N02CD03	NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists
MeSH PA	D000700	Analgesics
MeSH PA	D000077221	Calcitonin Gene-Related Peptide Receptor Antagonists
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents

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

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Disease	Relation	SNOMED_ID	DOID
Migraine	indication	37796009	DOID:6364
Prevention of migraine attacks	indication	408381007

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🐶 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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Calcitonin gene-related peptide 1	GPCR	P06881	CALCA_HUMAN	ANTIBODY BINDING	Kd	10.30		IUPHAR	DRUG LABEL

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External reference:

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ID	Source
017742	NDDF
10299	INN_ID
2056690	RXNORM
289669	MMSL
34962	MMSL
34963	MMSL
4037844	VANDF
4037845	VANDF
781125008	SNOMEDCT_US
781150006	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-202	INJECTION	225 mg	SUBCUTANEOUS	BLA	27 sections
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-202	INJECTION	225 mg	SUBCUTANEOUS	BLA	27 sections
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-202	INJECTION	225 mg	SUBCUTANEOUS	BLA	27 sections
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-204	INJECTION	225 mg	SUBCUTANEOUS	BLA	27 sections
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-204	INJECTION	225 mg	SUBCUTANEOUS	BLA	27 sections
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-204	INJECTION	225 mg	SUBCUTANEOUS	BLA	27 sections

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