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

fremanezumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Drug dosage:

Dose	Unit	Route
7.50	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
June 23, 2021	PMDA	OTSUKA PHARMACEUTICAL Co., Ltd.
Sept. 14, 2018	FDA	TEVA PHARMS USA
March 28, 2019	EMA	TEVA 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
Injection site erythema	375.61	25.43	171	6627	98331	90523318
Accidental exposure to product	371.82	25.43	134	6664	42232	90579417
Injection site pruritus	309.19	25.43	125	6673	53709	90567940
Injection site rash	267.74	25.43	91	6707	24082	90597567
Injection site swelling	237.60	25.43	107	6691	59732	90561917
Injection site pain	223.58	25.43	147	6651	173552	90448097
Device leakage	173.66	25.43	53	6745	9938	90611711
Injection site reaction	166.80	25.43	97	6701	91983	90529666
Incorrect dose administered by device	146.38	25.43	41	6757	5696	90615953
Device malfunction	131.66	25.43	52	6746	20925	90600724
Drug dose omission by device	111.16	25.43	38	6760	10193	90611456
Migraine	109.45	25.43	100	6698	190292	90431357
Injection site urticaria	103.82	25.43	42	6756	17969	90603680
Wrong technique in device usage process	76.61	25.43	25	6773	5810	90615839
Needle issue	71.82	25.43	30	6768	13904	90607745
Inappropriate schedule of product administration	69.49	25.43	70	6728	149863	90471786
Medication overuse headache	63.44	25.43	16	6782	1485	90620164
Injection site mass	61.52	25.43	31	6767	22059	90599590
Injection site warmth	59.03	25.43	28	6770	17487	90604162
Device delivery system issue	51.30	25.43	14	6784	1764	90619885
Incorrect dose administered	48.28	25.43	43	6755	78887	90542762
Wrong technique in product usage process	47.82	25.43	41	6757	71530	90550119
Injection site discharge	44.55	25.43	12	6786	1439	90620210
Abortion missed	40.85	25.43	12	6786	1970	90619679
Therapeutic response shortened	38.44	25.43	23	6775	22856	90598793
Headache	38.00	25.43	146	6652	862600	89759049
Device issue	33.07	25.43	23	6775	29514	90592135
Pruritus	32.81	25.43	102	6696	541423	90080226
Urticaria	32.38	25.43	72	6726	312662	90308987
Injection site vesicles	32.01	25.43	12	6786	4188	90617461
Constipation	31.82	25.43	67	6731	280328	90341321
Status migrainosus	31.15	25.43	6	6792	158	90621491
Device difficult to use	30.44	25.43	18	6780	17507	90604142
Device defective	30.40	25.43	11	6787	3475	90618174
Immediate post-injection reaction	30.17	25.43	7	6791	457	90621192
Injection site induration	30.05	25.43	15	6783	10453	90611196
Injection site oedema	29.12	25.43	9	6789	1754	90619895
Injection site extravasation	29.11	25.43	14	6784	9005	90612644
Product storage error	28.05	25.43	18	6780	20223	90601426
Product dose omission issue	26.70	25.43	64	6734	291623	90330026
Injection site cellulitis	26.12	25.43	8	6790	1513	90620136

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
Accidental exposure to product	48.33	38.47	16	603	20377	42600339

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
Injection site erythema	268.72	26.99	119	5532	94057	110489591
Injection site pruritus	267.69	26.99	100	5551	51158	110532490
Accidental exposure to product	209.03	26.99	83	5568	49925	110533723
Injection site swelling	201.96	26.99	86	5565	61704	110521944
Injection site rash	168.58	26.99	58	5593	23361	110560287
Injection site pain	137.67	26.99	95	5556	177827	110405821
Migraine	106.07	26.99	80	5571	171572	110412076
Injection site reaction	96.98	26.99	59	5592	89011	110494637
Device leakage	93.56	26.99	34	5617	16014	110567634
Drug dose omission by device	78.13	26.99	29	5622	14487	110569161
Inappropriate schedule of product administration	74.15	26.99	70	5581	203567	110380081
Injection site urticaria	73.32	26.99	29	5622	17186	110566462
Medication overuse headache	58.43	26.99	14	5637	1549	110582099
Wrong technique in device usage process	53.17	26.99	18	5633	6883	110576765
Device malfunction	50.15	26.99	25	5626	25533	110558115
Abortion missed	48.44	26.99	12	5639	1525	110582123
Injection site warmth	46.32	26.99	21	5630	17384	110566264
Headache	45.06	26.99	122	5529	882255	109701393
Therapeutic response shortened	43.91	26.99	24	5627	29559	110554089
Injection site mass	42.26	26.99	22	5629	24591	110559057
Pruritus	38.66	26.99	89	5562	581471	110002177
Incorrect dose administered by device	38.08	26.99	14	5637	6800	110576848
Injection site oedema	36.70	26.99	10	5641	1844	110581804
Needle issue	36.63	26.99	18	5633	17822	110565826
Injection site bruising	36.34	26.99	26	5625	51237	110532411
Device defective	29.56	26.99	10	5641	3812	110579836
Injection site discharge	29.48	26.99	8	5643	1452	110582196
Injection site vesicles	28.03	26.99	10	5641	4461	110579187
Product use issue	27.99	26.99	54	5597	311641	110272007
Product storage error	27.82	26.99	16	5635	21712	110561936
Immediate post-injection reaction	27.67	26.99	6	5645	425	110583223

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N02CD03	NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists
MeSH PA	D000077221	Calcitonin Gene-Related Peptide Receptor Antagonists
MeSH PA	D000700	Analgesics
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
CHEBI has role	CHEBI:35480	analgesic

Related Drugs by ATC class:

N02CD Calcitonin gene-related peptide (CGRP) antagonists 7 drugs

atogepanteptinezumaberenumabgalcanezumabrimegepantubrogepantzavegepant

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

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

🐶 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
Calcitonin gene-related peptide 1	GPCR	P06881	CALCA_HUMAN	ANTIBODY BINDING	Kd	10.30		IUPHAR	DRUG LABEL

External reference:

ID	Source
PF8K38CG54	UNII
4037844	VANDF
4037845	VANDF
C4549503	UMLSCUI
CHEBI:757206	CHEBI
CHEMBL4297756	ChEMBL_ID
DB14041	DRUGBANK_ID
D11055	KEGG_DRUG
10299	INN_ID
C000604315	MESH_SUPPLEMENTAL_RECORD_UI
9208	IUPHAR_LIGAND_ID
C000605816	MESH_SUPPLEMENTAL_RECORD_UI
781125008	SNOMEDCT_US
781150006	SNOMEDCT_US
289669	MMSL
34962	MMSL
34963	MMSL
d08897	MMSL
017742	NDDF
2056690	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-202	INJECTION	225 mg	SUBCUTANEOUS	BLA	28 sections
AJOVY	HUMAN PRESCRIPTION DRUG LABEL	1	51759-204	INJECTION	225 mg	SUBCUTANEOUS	BLA	28 sections