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

Stem definition	Drug id	CAS RN
human origin	5309	1426055-14-2

Description:

Molecule	Description
Synonyms: lanadelumab DX-2930 Lanadelumab-fyo SHP 643 takhzyro lanadelumab (genetical recombination)	Lanadelumab-flyo is a fully human monoclonal antibody (IgG1/kappa-light chain) that binds plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE.In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

lanadelumab
DX-2930
Lanadelumab-fyo
SHP 643
takhzyro
lanadelumab (genetical recombination)

Lanadelumab-flyo is a fully human monoclonal antibody (IgG1/kappa-light chain) that binds plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE.In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.

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

Drug dosage:

Dose	Unit	Route
21.40	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
Aug. 23, 2018	FDA	DYAX CORP
March 28, 2022	PMDA	Takeda Pharmaceutical Company Limited
Nov. 22, 2018	EMA	SHIRE PHARMACEUTICALS IRELAND LTD

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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
Hereditary angioedema	2065.07	34.29	352	2908	7210	63478552
Product dose omission issue	290.76	34.29	168	3092	234145	63251617
Inappropriate schedule of product administration	188.00	34.29	96	3164	103869	63381893
Product availability issue	149.33	34.29	36	3224	4085	63481677
COVID-19	123.42	34.29	75	3185	113028	63372734
Injection site pain	118.85	34.29	77	3183	129723	63356039
Insurance issue	84.82	34.29	25	3235	6096	63479666
Weight increased	66.46	34.29	74	3186	260718	63225044
Weight decreased	66.23	34.29	76	3184	276722	63209040
Stress	64.16	34.29	41	3219	67126	63418636

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FDA Adverse Event Reporting System (Male)

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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
Hereditary angioedema	580.34	54.20	79	587	968	34955297
Product dose omission issue	121.23	54.20	54	612	119657	34836608
Inappropriate schedule of product administration	72.01	54.20	31	635	62265	34894000
Product availability issue	63.74	54.20	13	653	1874	34954391
Weight increased	54.39	54.20	29	637	93004	34863261

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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
Hereditary angioedema	1877.02	42.18	296	2723	5039	79736330
Product dose omission issue	351.26	42.18	175	2844	247362	79494007
Product availability issue	200.93	42.18	43	2976	3904	79737465
Inappropriate schedule of product administration	184.12	42.18	93	2926	133535	79607834
Injection site pain	140.64	42.18	77	2942	129761	79611608
COVID-19	134.52	42.18	80	2939	157594	79583775
Weight increased	104.18	42.18	85	2934	277301	79464068
Weight decreased	101.36	42.18	93	2926	355105	79386264
Insurance issue	79.91	42.18	22	2997	5711	79735658
Product distribution issue	69.99	42.18	15	3004	1365	79740004

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B06AC05	BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Drugs used in hereditary angioedema
FDA EPC	N0000192750	Plasma Kallikrein Inhibitor
FDA MoA	N0000184151	Kallikrein Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Hereditary angioneurotic edema	indication	82966003	DOID:14735

🐶 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
Plasma kallikrein	Enzyme	P03952	KLKB1_HUMAN	ANTIBODY BINDING	IC50	10.05		IUPHAR	DRUG LABEL

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External reference:

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ID	Source
10265	INN_ID
2055641	RXNORM
2372V1TKXK	UNII
288339	MMSL
34817	MMSL
4037795	VANDF
773956002	SNOMEDCT_US
773961000	SNOMEDCT_US
9094	IUPHAR_LIGAND_ID
C000596550	MESH_SUPPLEMENTAL_RECORD_UI

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
TAKHZYRO	HUMAN PRESCRIPTION DRUG LABEL	1	47783-644	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	30 sections
TAKHZYRO	HUMAN PRESCRIPTION DRUG LABEL	1	47783-644	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	30 sections
TAKHZYRO	HUMAN PRESCRIPTION DRUG LABEL	1	47783-645	SOLUTION	150 mg	SUBCUTANEOUS	BLA	30 sections
TAKHZYRO	HUMAN PRESCRIPTION DRUG LABEL	1	47783-646	SOLUTION	300 mg	SUBCUTANEOUS	BLA	30 sections
TAKHZYRO	HUMAN PRESCRIPTION DRUG LABEL	1	47783-646	SOLUTION	300 mg	SUBCUTANEOUS	BLA	30 sections

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